Abilify® Medication Guide

Generic name: aripiprazole

Read this Medication Guide before you start taking ABILIFY and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about ABILIFY (aripiprazole)?

(For other side effects, also see “What are the possible side effects of ABILIFY?”).

Serious side effects may happen when you take ABILIFY, including:

• Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ABILIFY can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY is not approved for the treatment of patients with dementia-related psychosis.

• Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying

• attempts to commit suicide

• new or worse depression

• new or worse anxiety

• feeling very agitated or restless

• panic attacks

• trouble sleeping (insomnia)

• new or worse irritability

• acting aggressive, being angry, or violent

• acting on dangerous impulses

• an extreme increase in activity and talking (mania)

• other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

• Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

What is ABILIFY?

ABILIFY is a prescription medicine used to treat:

• schizophrenia in people age 13 years and older.

• bipolar I disorder in people age 10 years and older, including:

• manic or mixed episodes that happen with bipolar I disorder.

• manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate.

• long-term treatment of bipolar I disorder.

• major depressive disorder in adults, as an add-on treatment to an antidepressant medicine when you do not get better with an antidepressant alone.

• irritability associated with autistic disorder in children and adolescents ages 6 to 17 years old.

• agitation associated with schizophrenia or bipolar disorder.

The symptoms of schizophrenia include:

• losing touch with reality (psychosis)

• seeing things or hearing voices that are not there (hallucinations)

• believing things that are not true (delusions)

• being suspicious (paranoia)

• disorganized speech and thinking

• bizarre behavior

The symptoms of bipolar I disorder include:

• extreme mood swings that include feeling depressed and high or irritable mood

• talking too fast and too much

• impulsive behavior

• having more energy and restlessness than usual

• needing less sleep than usual

The symptoms of major depressive disorder (MDD) include:

• feeling of sadness and emptiness

• loss of interest in activities that you once enjoyed and loss of energy

• problems focusing and making decisions

• feeling of worthlessness or guilt

• changes in sleep or eating patterns

• thoughts of death or suicide

The symptoms of irritability associated with autistic disorder include:

• aggressive behavior towards others

• intentionally trying to harm oneself

• temper tantrums

• quickly changing moods

The symptoms of agitation associated with schizophrenia or bipolar disorder include:

• hostility or aggressive behavior

• agitation and inner tension

• self-exhausting behavior

What should I tell my healthcare provider before taking ABILIFY?

Before taking ABILIFY, tell your healthcare provider if you have or had:

• diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start ABILIFY and also during therapy.

• seizures (convulsions).

• low or high blood pressure.

• heart problems or stroke.

• pregnancy or plans to become pregnant. It is not known if ABILIFY will harm your unborn baby.

• breast-feeding or plans to breast-feed. It is not known if ABILIFY will pass into your breast milk. You and your healthcare provider should decide if you will take ABILIFY or breast-feed. You should not do both.

• low white blood cell count.

• phenylketonuria. ABILIFY DISCMELT Orally Disintegrating Tablets contain phenylalanine.

• any other medical conditions.

Tell your healthcare provider about all the medicines that you take or recently have taken, including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.

ABILIFY and other medicines may affect each other causing possible serious side effects. ABILIFY may affect the way other medicines work, and other medicines may affect how ABILIFY works.

Your healthcare provider can tell you if it is safe to take ABILIFY with your other medicines. Do not start or stop any medicines while taking ABILIFY without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I take ABILIFY?

• Take ABILIFY exactly as your healthcare provider tells you to take it.

Do not change the dose or stop taking ABILIFY yourself.

• ABILIFY can be taken with or without food.

• ABILIFY tablets should be swallowed whole.

• If you miss a dose of ABILIFY, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of ABILIFY at the same time.

• If you have been prescribed ABILIFY DISCMELT, take it as follows:

• Do not open the blister until ready to take the DISCMELT tablet.

• To remove one DISCMELT tablet, open the package and peel back the foil on the blister to expose the tablet.

• Do not push the tablet through the foil because this could damage the tablet.

• Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ABILIFY DISCMELT Orally Disintegrating Tablet on the tongue.

• Tablet disintegration occurs rapidly in saliva. It is recommended that ABILIFY DISCMELT be taken without liquid. However, if needed, it can be taken with liquid.

• Do not attempt to split the DISCMELT tablet.

• If you take too much ABILIFY, call your healthcare provider or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

What should I avoid while taking ABILIFY?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABILIFY affects you. ABILIFY may make you drowsy.

• Do not drink alcohol while taking ABILIFY.

• Avoid getting over-heated or dehydrated.

• Do not over-exercise.

• In hot weather, stay inside in a cool place if possible.

• Stay out of the sun. Do not wear too much or heavy clothing.

• Drink plenty of water.

What are the possible side effects of ABILIFY?

Serious side effects have been reported with ABILIFY including: Also see “What is the most important information I should know about ABILIFY?” at the beginning of this Medication Guide.

• Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.

• High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take ABILIFY. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start ABILIFY and during therapy.

Call your healthcare provider if you have any of these symptoms of high blood sugar while taking ABILIFY:

• feel very thirsty

• need to urinate more than usual

• feel very hungry

• feel weak or tired

• feel sick to your stomach

• feel confused, or your breath smells fruity.

• Difficulty swallowing: may lead to aspiration and choking.

• Tardive dyskinesia: Call your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking ABILIFY. Tardive dyskinesia may also start after you stop taking ABILIFY.

• Orthostatic hypotension (decreased blood pressure): lightheadedness or fainting when rising too quickly from a sitting or lying position.

• Low white blood cell count

• Seizures (convulsions)

Common side effects with ABILIFY in adults include:

• nausea • inner sense of restlessness/need to move

• vomiting (akathisia)

• constipation • anxiety

• headache • insomnia

• dizziness • restlessness

Common side effects with ABILIFY in children include:

• feeling sleepy • insomnia

• headache • nausea

• vomiting • stuffy nose

• fatigue • weight gain

• increased appetite • uncontrolled movement such as restlessness, tremor, muscle stiffness

These are not all the possible side effects of ABILIFY. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ABILIFY?

• Store ABILIFY at room temperature, between 59°F to 86°F (15°C to 30°C).

• Opened bottles of ABILIFY Oral Solution can be used for up to

6 months after opening, but not beyond the expiration date on the bottle.

Keep ABILIFY and all medicines out of the reach of children.

General information about ABILIFY

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABILIFY for a condition for which it was not prescribed. Do not give ABILIFY to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about ABILIFY. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ABILIFY that was written for healthcare professionals. For more information about ABILIFY visit www.abilify.com.

What are the ingredients in ABILIFY?

Active ingredient: aripiprazole

Inactive ingredients:

Tablets: cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.

ABILIFY DISCMELT Orally Disintegrating Tablets: acesulfame potassium, aspartame (which contains phenylalanine), calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.

ABILIFY Oral Solution: disodium edetate, fructose (200 mg per mL), glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose (400 mg per mL), and purified water. The oral solution is flavored with natural orange cream and other natural flavors.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

ABILIFY is a trademark of Otsuka Pharmaceutical Company.

Source: http://packageinserts.bms.com/medguide/medguide_abilify.pdf

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Psychotherapy, or “talk therapy,” is a way to treat people with a mental disorder by helping them understand their illness. It teaches people strategies and gives them tools to deal with stress and unhealthy thoughts and behaviors. Psychotherapy helps patients manage their symptoms better and function at their best in everyday life.

Sometimes psychotherapy alone may be the best treatment for a person, depending on the illness and its severity. Other times, psychotherapy is combined with medications. Therapists work with an individual or families to devise an appropriate treatment plan.

What are the different types of psychotherapy?

Many kinds of psychotherapy exist. There is no “one-size-fits-all” approach. In addition, some therapies have been scientifically tested more than others. Some people may have a treatment plan that includes only one type of psychotherapy. Others receive treatment that includes elements of several different types. The kind of psychotherapy a person receives depends on his or her needs.

This section explains several of the most commonly used psychotherapies. However, it does not cover every detail about psychotherapy. Patients should talk to their doctor or a psychotherapist about planning treatment that meets their needs.

Cognitive Behavioral Therapy

Cognitive behavioral therapy (CBT) is a blend of two therapies: cognitive therapy (CT) and behavioral therapy. CT was developed by psychotherapist Aaron Beck, M.D., in the 1960′s. CT focuses on a person’s thoughts and beliefs, and how they influence a person’s mood and actions, and aims to change a person’s thinking to be more adaptive and healthy. Behavioral therapy focuses on a person’s actions and aims to change unhealthy behavior patterns.

CBT helps a person focus on his or her current problems and how to solve them. Both patient and therapist need to be actively involved in this process. The therapist helps the patient learn how to identify distorted or unhelpful thinking patterns, recognize and change inaccurate beliefs, relate to others in more positive ways, and change behaviors accordingly.

CBT can be applied and adapted to treat many specific mental disorders.
CBT for depression

Many studies have shown that CBT is a particularly effective treatment for depression, especially minor or moderate depression. Some people with depression may be successfully treated with CBT only. Others may need both CBT and medication. CBT helps people with depression restructure negative thought patterns. Doing so helps people interpret their environment and interactions with others in a positive and realistic way. It may also help a person recognize things that may be contributing to the depression and help him or her change behaviors that may be making the depression worse.

CBT for anxiety disorders

CBT for anxiety disorders aims to help a person develop a more adaptive response to a fear. A CBT therapist may use “exposure” therapy to treat certain anxiety disorders, such as a specific phobia, post traumatic stress disorder, or obsessive compulsive disorder. Exposure therapy has been found to be effective in treating anxiety-related disorders.  It works by helping a person confront a specific fear or memory while in a safe and supportive environment. The main goals of exposure therapy are to help the patient learn that anxiety can lessen over time and give him or her the tools to cope with fear or traumatic memories.

A recent study sponsored by the Centers for Disease Control and Prevention concluded that CBT is effective in treating trauma-related disorders in children and teens.

CBT for bipolar disorder

People with bipolar disorder usually need to take medication, such as a mood stabilizer. But CBT is often used as an added treatment. The medication can help stabilize a person’s mood so that he or she is receptive to psychotherapy and can get the most out of it. CBT can help a person cope with bipolar symptoms and learn to recognize when a mood shift is about to occur. CBT also helps a person with bipolar disorder stick with a treatment plan to reduce the chances of relapse (e.g., when symptoms return).
CBT for eating disorders

Eating disorders can be very difficult to treat. However, some small studies have found that CBT can help reduce the risk of relapse in adults with anorexia who have restored their weight.  CBT may also reduce some symptoms of bulimia, and it may also help some people reduce binge-eating behavior.

CBT for schizophrenia

Treating schizophrenia with CBT is challenging. The disorder usually requires medication first. But research has shown that CBT, as an add-on to medication, can help a patient cope with schizophrenia.5 CBT helps patients learn more adaptive and realistic interpretations of events. Patients are also taught various coping techniques for dealing with “voices” or other hallucinations. They learn how to identify what triggers episodes of the illness, which can prevent or reduce the chances of relapse.

CBT for schizophrenia also stresses skill-oriented therapies. Patients learn skills to cope with life’s challenges. The therapist teaches social, daily functioning, and problem-solving skills. This can help patients with schizophrenia minimize the types of stress that can lead to outbursts and hospitalizations.

Source: http://www.nimh.nih.gov/health/topics/psychotherapies/index.shtml

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Attention Deficit Hyperactivity Disorder (ADHD) is a condition that becomes apparent in some children in the preschool and early school years. It is hard for these children to control their behavior and/or pay attention. It is estimated that between 3 and 5 percent of children have ADHD, or approximately 2 million children in the United States. This means that in a classroom of 25 to 30 children, it is likely that at least one will have ADHD. (Source: NIMH, www.nimh.nih.gov, accessed February 11, 2009)

Autism Spectrum Disorder also known as Pervasive Developmental Disorders (PDDs), cause severe and pervasive impairment in thinking, feeling, language, and the ability to relate to others. A recent study of a U.S. metropolitan area estimated that 3.4 of every 1,000 children 3-10 years old had autism. (Source: NIMH, www.nimh.nih.gov, accessed February 11, 2009)

Bipolar Disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in a person’s mood, energy, and ability to function. About 5.7 million American adults or about 2.6 percent of the population age 18 and older in any given year, have bipolar disorder. Both children and adolescents can develop bipolar disorder. It is more likely to affect the children of parents who have the illness. (Source: NIMH, www.nimh.nih.gov, accessed February 11, 2009)

Conduct disorder, also known as disruptive behavior disorder, is a disorder that involves chronic behavior problems during childhood and adolescence including stealing, fighting, or bullying others. Conduct disorder affects 1 to 4 percent of 9- to 17-year-olds, depending on exactly how the disorder is defined, and seems to be more common in boys than in girls. (Source: SAMHSA, www.mentalhealth.samhsa.gov, accessed March 18, 2009)

Depression is a treatable illness. Major depression is more than a sad mood, depression affects a young person’s ability to think, feel, and behave in a normal manner. Major depression can lead to school failure, alcohol and drug use, and even suicide. At any point in time, 1 in every 10 children and adolescents are affected by serious emotional disturbances. (Source: SAMHSA, www.mentalhealth.samhsa.gov, accessed March 18, 2009)

Eating Disorders are severe disturbances in eating behavior. There are two main types of eating disorders: anorexia nervosa and bulimia nervosa. Eating disorders frequently appear in adolescence. Although eating disorders are more common in females, approximately 5 to 15 percent of individuals diagnosed with anorexia or bulimia are male. Individuals with anorexia are up to ten times more likely to die because of their illness. (Source: NIMH, www.nimh.nih.gov, accessed March 18, 2009)

Oppositional Defiant Disorder (ODD) is a persistent pattern of disobedient, hostile, and defiant behavior towards various authority figures. Some studies have shown that 1 to 6 percent of the school-age population is affected. The disorder is more common in boys prior to puberty but after puberty, both genders are equal. (Source: SAMHSA, www.mentalhealth.samhsa.gov, accessed March 18, 2009)

Post-Traumatic Stress Disorder (PTSD) is a condition that affects individuals who have experienced a disturbing or frightening event. PTSD generally starts within three months of the event, however for some individuals it doesn’t appear until much later. In any given year, 5.2 million Americans (including children and adolescents) suffer from PTSD. (Source: SAMHSA, www. mentalhealth.samhsa.gov, accessed March 18, 2009)

Risk-Taking Behavior is any action that increases the likelihood of injury or death. 72% of all deaths among 10-24 year-olds result from four causes: motor-vehicle crashes, other unintentional injuries, homicide, and suicide. The 2007 National Youth Risk Behavior Survey indicated that over a thirty day span, 29.1% of high school students surveyed had ridden in a car with a driver who had been drinking alcohol and 18% had carried a weapon. Over a 12 month span, 6.9% of high school students had attempted suicide, 75% had drunk alcohol, and 47.8% had sexual intercourse. (Source: Eaton, et. al., Youth Risk Behavior Surveillance–United States, 2007, CDC, www.cdc.gov, accessed March 18, 2009.)

Schizophrenia is a chronic and disabling brain disorder. It affects about 1% of Americans. Psychotic symptoms usually appear in males during their late teens and early 20s and in females in their mid-20s to early 30s. Symptoms seldom appear after the age of 45 and rarely before puberty. (Source: NIMH, www.nimh.nih.gov, accessed March 18, 2009)

Suicide is the third leading cause of death for 15-to-24-year-olds, among this age group, suicide accounts for 12.3% of all deaths. In 2007, 6.9% of high school student surveyed through the Youth Risk Behavior Survey indicated they had attempted suicide in the last 12 months, and 14.5% had seriously considered attempting suicide. The warning signs and risk factors associated with suicide include: depression, previous suicide attempts, recent losses, frequent thoughts about death, and the use of drugs or alcohol. (Source: CDC, www.cdc.gov, accessed March 18, 2009)

Child and Adolescent Drug Abuse Statistics

An estimated 19.9 million Americans aged 12 or older were current users of an illicit drug in 2007. This estimate represents 8.0 percent of the population.

An estimated 70.9 million Americans reported being current users of a tobacco product in 2007, a prevalence rate of 28.6% of the population 12 years and older.

Marijuana is the most widely used illicit substance in this country. In 2007, 14.4 million people were current users of marijuana.

Vicodin is one of the drugs most commonly abused by adolescents. In 2008, 15.4% of 12th graders reporting using a prescription drug for non-medical purposes in the last year.

(Source: NIDA, www.nida.nih.gov, accessed March 18, 2009. Data provided from the NIDA funded Monitoring the Future: National Survey Results on Drug Use and the SAMHSA funded 2007 National Survey on Drug Use and Health.)[1]

Source:

1-http://www.aacap.org/cs/root/resources_for_families/child_and_adolescent_mental_illness_statistics

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Tablets 5 mg, 10 mg

THERAPEUTIC CLASSIFICATION

Anxiolytic-sedative

ACTIONS AND CLINICAL PHARMACOLOGY

‘Valium’ (diazepam) is an anxiolytic-sedative drug useful in the symptomatic relief of anxiety and tension states. It has also adjunctive value in the relief of certain neurospastic conditions.

ABSORPTION:

Diazepam is rapidly and completely absorbed from the gastrointestinal tract, peak plasma concentrations appearing 30-90 minutes after oral ingestion.

DISTRIBUTION:

Diazepam and its metabolites are highly bound to plasma proteins (diazepam 98%). The volume of distribution at steady state is 0.8-1.0 L/kg. In humans, comparable blood levels of ‘Valium’ were obtained in maternal and cord blood indicating placental transfer of the drug.

METABOLISM:

Diazepam is mainly metabolized to the pharmacologically active metabolites such as N-desmethyldiazepam, temazepam and oxazepam.

ELIMINATION:

The acute half-life is six to eight hours with a slower decline thereafter (half-life up to 48 hours). The terminal elimination half-life of the active metabolite N-desmethyldiazepam is up to 100 hours. Diazepam and its metabolites are excreted mainly in the urine, predominantly in their conjugated forms. The clearance of diazepam is 20-30 mL/min.

PHARMACOKINETICS IN SPECIAL CLINICAL SITUATIONS :

The elimination half-life may be prolonged in the newborn, in the elderly and in patients with liver disease. In renal failure the half-life of diazepam is unchanged.

INDICATIONS

Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

‘Valium’ (diazepam) is useful in the symptomatic management of mild to moderate degrees of anxiety in conditions dominated by tension, excitation, agitation, fear or aggressiveness, such as may occur in:-psychoneurosis, anxiety reactions due to stress conditions and anxiety states with somatic expression. In acute alcoholic withdrawal, ‘Valium’ may be useful in the symptomatic relief of acute agitation, tremor and impending acute delirium tremens. ‘Valium’ is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology, such as inflammation of the muscle and joints or secondary to trauma; spasticity caused by upper motor neuron disorders, such as cerebral palsy and paraplegia; athetosis and the rare “stiff man syndrome”.

CONTRAINDICATIONS

‘Valium’ (diazepam) is contraindicated in patients with:

A known hypersensitivity to benzodiazepines, severe respiratory insufficiency, severe hepatic insufficiency, sleep apnea syndrome, myasthenia gravis and, because of lack of sufficient clinical experience, in children under six months of age.

WARNINGS

‘Vailum’ (diazepam) is not recommended in patients with dependence on other substances including alcohol. An exception to the latter is the management of acute withdrawal reactions.

Benzodiazepines are not recommended for the primary treatment of psychotic illness.

Benzodiazepines should not be used alone to treat depression or anxiety associated with depression as suicide may occur in such patients.

PRECAUTIONS

Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse.

A lower dose is recommended for patients with chronic respiratory insufficiency, due to the risk of respiratory depression.

TOLERANCE:

Some loss of response to the effects of benzodiazepines may develop after repeated use of ‘Valium’ (diazepam) for prolonged time.

DEPENDENCE:

Use of benzodiazepines and benzodiazepine-like agents may lead to the development of physical and psychological dependence. This risk of dependence increases with dose and duration of treatment (48,56,57]; it is also greater in predisposed patients with a history of alcohol or drug abuse.

WITHDRAWAL:

Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.

REBOUND ANXIETY:

A transient syndrome whereby the symptoms that led to treatment with ‘Valium’ recur in an enhanced form. This may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness.

Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually.

AMNESIA:

It should be borne in mind that benzodiazepines may induce anterograde amnesia. Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Effects of this may be associated with inappropriate behaviour.

PSYCHIATRIC AND ‘PARADOXICAL’ REACTIONS:

Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines. Should this occur, the use of the drug should be discontinued. They are more likely to occur in children and in the elderly.

USE IN ELDERLY:

Elderly and debilitated patients or those with organic brain disorders have been found to be prone to central nervous system depression following even low doses. For these patients it is recommended that the dosage be limited to the smallest, effective amount to preclude development of ataxia, over sedation or other possible adverse effects.

USE IN EPILEPTIC PATIENT:

Careful consideration should be given if ‘Valium’ is to be used in patients with epilepsy as the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the doses of standard anticonvulsant medication. An abrupt withdrawal of ‘Valium’ in such cases may also be associated with the temporary increase in the frequency and/or severity of seizures.

USE IN PREGNANCY AND NURSING:

The safety of diazepam for use in pregnancy has not been established. An increased risk of congenital malformation associated with the use of benzodiazepines during the first trimester of pregnancy has been suggested. ‘Valium’ Injection should not be used during pregnancy except if absolutely necessary.

Continuous administration of benzodiazepines during pregnancy may give rise to hypotension, reduced respiratory function and hypothermia in the newborn child. Withdrawal symptoms in newborn infants have occasionally been reported with this class of drug. Special care must be taken when ‘Valium’ is used during labour and delivery, as high single doses may produce irregularities in the fetal heart rate and hypotonia, poor sucking, hypothermia and moderate respiratory depression in the neonate. With new born infants it must be remembered that the enzyme system involved in the breakdown of the drug is not yet fully developed (especially in premature infants).

Diazepam passes into breast milk. Breast-feeding is therefore not recommended in patients receiving ‘Valium’.

GENERAL:

Patients receiving ‘Valium’ should be advised to proceed cautiously wherever mental alertness and physical coordination are required. The usual precautions in treating patients with impaired renal and hepatic functions should be observed. If ‘Valium’ is administered for protracted periods, periodic blood counts and liver function tests would be highly advisable.

DRUG INTERACTIONS:

Careful consideration should be given if ‘Valium’ is to be combined with other centrally acting agents, such as (antipsychotics, anxiolytics/sedatives, antidepressants, hypnotics, anticonvulsants, narcotic analgesics, anesthetics and sedative antihistamines because the pharmacological action of these (84) agents might potentiate or be potentiated by the action of ‘Valium’. Since ‘Valium’ has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other central nervous system depressant drugs during ‘Valium’ therapy.

There is potentially relevant interaction between diazepam and compounds which inhibit certain hepatic enzymes (particularly cytochrome P 450 III A). Data indicate that these compounds influence the pharmacokinetics of diazepam and may lead to increased and prolonged sedation. At present this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine and fluoxetine and omeprazole.

There have also been reports that the metabolic elimination of phenytoin is affected by diazepam.

Cisapride may lead to a temporary increase in the sedative effects of orally administered benzodiazepines due to faster absorption.

ADVERSE REACTIONS

The most common adverse reactions reported for ‘Valium’ (diazepam) are fatigue, drowsiness, muscle weakness and ataxia. These phenomena occur predominantly at the start of therapy and usually disappear with prolonged administration.

The following may also occur: dizziness, nausea, dry mouth or hypersalivation, blurred vision, diplopia, headache, slurred speech, tremors, dysarthria, confusion, depression, incontinence or urinary retention, constipation, gastrointestinal disturbances, skin rash, generalized exfoliative dermatitis, hypotension and changes in libido; very rarely, elevated transaminases and alkaline phosphatase have been reported occasionally.

Other reactions noted less frequently are vertigo, hypoactivity, euphoria and impairment of memory.

Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages.

Effects of this be associated with inappropriate behaviour.

The more serious adverse reactions occasionally reported are leucopenia, jaundice and hypersensitivity.

PSYCHIATRIC AND ‘PARADOXICAL’ REACTIONS:

Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines . Should these occur, the drug should be discontinued. They are more likely to occur in children and in the elderly.

Minor changes in EEG patterns have been observed in patients on. ‘Valium’ therapy. These changes consist of low to moderate voltage fast activity, 20 to 30 cycles per second and are of no known significance.

Chronic use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in withdrawal or rebound phenomena.

Abuse of benzodiazepines has been reported.

SYMPTOMS AND TREATMENT OF OVERDOSAGE

SYMPTOMS

The main symptoms of overdosage are drowsiness, over sedation and ataxia. When the effects of the drug overdosage begin to wear off, the patient exhibits some jitteriness and overstimulation. The cardinal manifestations of overdosage are drowsiness and confusion, reduced reflexes and coma (rarely) and death (very rarely). However, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol). There are minimum effects on respiration, pulse and blood pressure unless the overdosage is extreme.

TREATMENT

In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken. Vomiting should be induced (within 1 hour) if the patient is conscious or gastric lavage, with the airway protected if the patient is unconscious, may be beneficial if performed soon after oral ingestion of ‘Valium’ (diazepam). If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. If necessary, a CNS stimulant such as caffeine or methylphenidate may be administered with caution. Supportive measures should be instituted as indicated:- maintenance of an adequate airway, levarterenol or metaraminol bitartrate for hypotension. Flumazenil may be useful as an antagonist. Caution should be observed in the use of flumazenil in epileptics treated with benzodiazepines. Dialysis appears to be of little value.

DOSAGE AND ADMINISTRATION

Dosage for ‘Valium’ (diazepam) should be individualized for maximal beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In the first few days of administration a cumulative effect of drug may occur, and therefore, the dosage should be increased only after stabilization is apparent.

DURATION OF TREATMENT

The duration of treatment should be as short as possible. The patient should be reassessed regularly and the need for continued treatment evaluated, especially if the patient is symptom free. It should not exceed 2- 3 months, including the tapering-off period. Extension beyond this period should not take place without reevaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration and explain precisely how the dosage will be progressively decreased. Moreover, it is important that the patient be aware of the possibility of rebound phenomena, thereby minimizing anxiety over such symptoms should they occur during withdrawal. There is evidence that, in the case of shortacting benzodiazepines, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high. When long-acting benzodiazepines such as diazepam are being used, it is important to warn against changing to a short-acting benzodiazepine as withdrawal symptoms may develop.

USUAL DAILY DOSE

ADULTS:

Symptomatic relief of anxiety and tension in psychoneurosis and anxiety reactions:Depending upon severity of symptoms – 2 mg to 10 mg, two to four times daily.

Symptomatic relief in acute alcohol withdrawal: 10 mg, three or four times during timehe first 24 hours, reducing to 5 mg, three or four ts daily as needed.

Adjunctively for relief of skeletal muscle spasm: 2 mg to 10 mg, three to four times daily.

Elderly and debilitated patients, or in thepresence of debilitating disease: 2 mg, one or two times daily initially, increase gradually as needed and tolerated

CHILDREN:

Because of varied responses, initiate therapy with lowest dose and increase as required. Not for use in children under six months. (See Contraindications):  1 mg to 2½ mg, three or four times daily initially; increase gradually as needed and tolerated.

PHARMACEUTICAL INFORMATION

CHEMISTRY: ‘Valium’ contains as active substance diazepam (7-chloro- 1, 3-dihydro-l-methyl-5-phenyl-2H-1, 4-benzodiazepine-2- one), a benzodiazepine derivative. It is a colorless, crystalline compound, insoluble in water and has a molecular weight of 284.74.

STRUCTURAL FORMULA

COMPOSITION: ‘Valium’ is available for oral administration as tablets containing 5 mg of diazepam. Non-medicinal ingredients are corn starch, iron oxide yellow, lactose and magnesium stearate.

AVAILABILITY OF DOSAGE FORMS

‘Valium’ (diazepam) Scored Tablets: 5 mg, yellow; and 10 mg, blue.

PRESCRIBING INFORMATION

VALIUM® ROCHE®

(diazepam)

Tablets

5 mg, 10 mg

ANXIOLYTIC-SEDATIVE

HOFFMANN-LA ROCHE LIMITED DATE OF PREPARATION:

2455 Meadowpine Boulevard December 18, 1969

MISSISSAUGA, ONTARIO L5N 6L7

Date of Revision:

March 12, 1998

®Registered Trademark

Copyright 1998 – Hoffmann-La Roche Ltd.

CAN 6053

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Sertraline hydrochloride (trade names Zoloft and Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It was introduced to the market by Pfizer in 1991. Sertraline is primarily used to treat major depression in adult outpatients as well as obsessive–compulsive, panic, and social anxiety disorders in both adults and children. In 2007, it was the most prescribed antidepressant on the U.S. retail market, with 29,652,000 prescriptions.

The efficacy of sertraline for depression is similar to that of older tricyclic antidepressants, but its side effects are much less pronounced. Differences with newer antidepressants are subtler and also mostly confined to side effects. Evidence suggests that sertraline may work better than fluoxetine (Prozac) for some subtypes of depression. Sertraline is highly effective for the treatment of panic disorder, but cognitive behavioral therapy is a better treatment for obsessive-compulsive disorder, whether by itself or in combination with sertraline. Although approved for social phobia and posttraumatic stress disorder, sertraline leads to only modest improvement in these conditions. Sertraline also alleviates the symptoms of premenstrual dysphoric disorder and can be used in sub-therapeutic doses or intermittently for its treatment.

Sertraline shares the common side effects and contraindications of other SSRIs, with high rates of nausea, diarrhea, insomnia, and sexual side effects; however, its effects on cognition are mild. The unique effect of sertraline on dopaminergic neurotransmission may be related to its favorable action on cognitive functions. In pregnant women taking sertraline, the drug was present in significant concentrations in fetal blood, and was also associated with a higher rate of various birth defects. Similarly to other antidepressants, the use of sertraline for depression may be associated with a higher rate of suicidality. Due to the rarity of this side effect, statistically significant data are difficult to obtain, and suicidality continues to be a subject of controversy.(1)

Definition

Sertraline is an antidepressant that belongs to the class of drugs called selective serotonin reuptake inhibitors (SSRIs). In the in United States it is sold under the brand name Zoloft.

Purpose

Sertraline is used to treat depression, obsessive-compulsive disorder , panic disorder , and post-traumatic stress disorder .

Description

Serotonin, one of the neurotransmitters , is a brain chemical that carries nerve impulses from one nerve cell to another. Researchers think that depression and certain other mental disorders may be caused, in part, because there is not enough serotonin being released and transmitted in the brain. Like the other SSRI antidepressants, fluvoxamine (Luvox), fluoxetine (Prozac), and paroxetine (Paxil), sertraline increases the level of brain serotonin (also known as 5-HT). Increased serotonin levels in the brain may be beneficial in patients with obsessive-compulsive disorder, alcoholism, certain types of headaches, post-traumatic stress disorder (PTSD), pre-menstrual tension and mood swings, and panic disorder. Sertraline is not more or less effective than the other SSRI drugs although selected characteristics of each drug in this class may offer greater benefits in some patients. Fewer drug interactions have been reported with sertraline, however, than with other medications in the same class.

The benefits of sertraline develop slowly over a period of up to four weeks. Patients should be aware of this and continue to take the drug as directed, even if they feel no immediate improvement.

Sertraline is available in 25-mg, 50-mg and 100-mg tablets, or as a 20-mg per ml solution.

Recommended dosage

The recommended dosage of sertraline depends on the disorder being treated. The initial recommended dosage for depression and obsessive-compulsive disorder is 50 mg daily. This may be increased at intervals of at least one week to the maximum recommended dosage of 200 mg daily. For the treatment of panic disorder and post-traumatic stress disorder, the initial dose is 25 mg once daily. This dosage is increased to 50 mg daily after one week. If there is no therapeutic response, the dosage may be increased to the maximum of 200 mg daily at intervals of at least one week. These dosages may need to be reduced in elderly patients (over age 65) or in people with liver disease.

For the treatment of obsessive-compulsive disorder in the pediatric population, treatment should be initiated at a dose of 25 mg per day in children six to 12 years of age and 50 mg per day in children 13 to 17 years of age. Doses may be increased at one-week intervals to a total daily dose of 200 mg.

Precautions

A group of serious side effects, called serotonin syndrome, have resulted from the combination of antidepressants such as sertraline and members of another class of antidepressants known as monoamine oxidase (MAO) inhibitors. Serotonin syndrome usually consists of at least three of the following symptoms: diarrhea, fever, sweatiness, mood or behavior changes, overactive reflexes, fast heart rate, restlessness, shivering or shaking. Because of this, sertraline should never be taken in combination with MAO inhibitors. Patient taking any MAO inhibitors, for example Nardil ( phenelzine sulfate) or Parmate ( tranylcypromine sulfate), should stop the MAO inhibitor then wait at least 14 days before starting sertraline or any other antidepressant. The same holds true when discontinuing sertraline and starting an MAO inhibitor. Also, people should not take sertraline oral concentrate while using disulfiram (Antabuse). Sertraline should never be taken by people who are any other SSRI antidepressants.

Sertraline should be used with cautiously and with close physician supervision by people with a prior history of seizures , people who are at an increased risk of bleeding, and those for whom weight loss is undesirable. Sertraline may precipitate a shift to mania in patients with bipolar (formerly manic-depressive) disease.

Side effects

More than 5% of patients experience insomnia , dizziness, and headache. About 14% of men report delayed ejaculation while 6% report decreased sex drive while taking this drug. In order to reduce these sexual side effects, patients can wait for tolerance to develop (this may take up to 12 weeks), reduce the dose, have drug holidays (where the weekend dose is either decreased or skipped), or discus with their physician using a different antidepressant.

More than 10% of patients report nausea and diarrhea while taking sertraline. Other possible side effects include agitation, anxiety, rash, constipation, vomiting, tremors, or visual difficulty. Although most side effects eventually subside, it may take up to four weeks for people to adjust to the drug.

Interactions

Sertraline interacts with St. John’s Wort , an herbal remedy for depression. The risk of seizures is increased in patients using tramadol and sertraline. Taking sertraline with MAO inhibitors may result in the serious side effects discussed above. Erythromycin, an antibiotic, may inhibit the breakdown of sertraline in the liver and cause increased central nervous system effects such as drowsiness and decreasing of mental alertness. Other antidepressants should not be taken by people using sertraline except in rare cases when prescribed by a physician. If a combination of antidepressants is considered beneficial, a low dose of tricyclic antidepressants (10–25 mg daily) should be used.

Sertraline should not be taken with grapefruit juice as the combination may increase sertraline levels in the body. (2)

Sources:

1- http://en.wikipedia.org/wiki/Sertraline

2- http://www.minddisorders.com/Py-Z/Sertraline.html

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Depression is a serious disorder that can cause significant problems in mood, thinking, and behavior at home, in school, and with peers. It is estimated that major depressive disorder (MDD) affects about 5 percent of adolescents.

Research has shown that, as in adults, depression in children and adolescents is treatable. Certain antidepressant medications, called selective serotonin reuptake inhibitors (SSRIs), can be beneficial to children and adolescents with MDD. Certain types of psychological therapies also have been shown to be effective. However, our knowledge of antidepressant treatments in youth, though growing substantially, is limited compared to what we know about treating depression in adults.

Recently, there has been some concern that the use of antidepressant medications themselves may induce suicidal behavior in youths. Following a thorough and comprehensive review of all the available published and unpublished controlled clinical trials of antidepressants in children and adolescents, the U.S. Food and Drug Administration (FDA) issued a public warning in October 2004 about an increased risk of suicidal thoughts or behavior (suicidality) in children and adolescents treated with SSRI antidepressant medications. In 2006, an advisory committee to the FDA recommended that the agency extend the warning to include young adults up to age 25.

More recently, results of a comprehensive review of pediatric trials conducted between 1988 and 2006 suggested that the benefits of antidepressant medications likely outweigh their risks to children and adolescents with major depression and anxiety disorders. The study, partially funded by NIMH, was published in the April 18, 2007, issue of the Journal of the American Medical Association.1

What Did the FDA Review Find?

In the FDA review, no completed suicides occurred among nearly 2,200 children treated with SSRI medications. However, about 4 percent of those taking SSRI medications experienced suicidal thinking or behavior, including actual suicide attempts—twice the rate of those taking placebo, or sugar pills.

In response, the FDA adopted a “black box” label warning indicating that antidepressants may increase the risk of suicidal thinking and behavior in some children and adolescents with MDD. A black-box warning is the most serious type of warning in prescription drug labeling.

The warning also notes that children and adolescents taking SSRI medications should be closely monitored for any worsening in depression, emergence of suicidal thinking or behavior, or unusual changes in behavior, such as sleeplessness, agitation, or withdrawal from normal social situations. Close monitoring is especially important during the first four weeks of treatment. SSRI medications usually have few side effects in children and adolescents, but for unknown reasons, they may trigger agitation and abnormal behavior in certain individuals.
What Do We Know About Antidepressant Medications?

The SSRIs include:
fluoxetine (Prozac)
sertraline (Zoloft)
paroxetine (Paxil)
citalopram (Celexa)
escitalopram (Lexapro)
fluvoxamine (Luvox)

Another antidepressant medication, venlafaxine (Effexor), is not an SSRI but is closely related.

SSRI medications are considered an improvement over older antidepressant medications because they have fewer side effects and are less likely to be harmful if taken in an overdose, which is an issue for patients with depression already at risk for suicide. They have been shown to be safe and effective for adults.

However, use of SSRI medications among children and adolescents ages 10 to 19 has risen dramatically in the past several years. Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older. The other SSRI medications and the SSRI-related antidepressant venlafaxine have not been approved for treatment of depression in children or adolescents, but doctors still sometimes prescribe them to children on an “off-label” basis. In June 2003, however, the FDA recommended that paroxetine not be used in children and adolescents for treating MDD.

Fluoxetine can be helpful in treating childhood depression, and can lead to significant improvement of depression overall. However, it may increase the risk for suicidal behaviors in a small subset of adolescents. As with all medical decisions, doctors and families should weigh the risks and benefits of treatment for each individual patient.

What Should You Do for a Child With Depression?

A child or adolescent with MDD should be carefully and thoroughly evaluated by a doctor to determine if medication is appropriate. Psychotherapy often is tried as an initial treatment for mild depression. Psychotherapy may help to determine the severity and persistence of the depression and whether antidepressant medications may be warranted. Types of psychotherapies include “cognitive behavioral therapy,” which helps people learn new ways of thinking and behaving, and “interpersonal therapy,” which helps people understand and work through troubled personal relationships.

Those who are prescribed an SSRI medication should receive ongoing medical monitoring. Children already taking an SSRI medication should remain on the medication if it has been helpful, but should be carefully monitored by a doctor for side effects. Parents should promptly seek medical advice and evaluation if their child or adolescent experiences suicidal thinking or behavior, nervousness, agitation, irritability, mood instability, or sleeplessness that either emerges or worsens during treatment with SSRI medications.

Once started, treatment with these medications should not be abruptly stopped. Although they are not habit-forming or addictive, abruptly ending an antidepressant can cause withdrawal symptoms or lead to a relapse. Families should not discontinue treatment without consulting their doctor.

All treatments can be associated with side effects. Families and doctors should carefully weigh the risks and benefits, and maintain appropriate follow-up and monitoring to help control for the risks.

What Does Research Tell Us?

An individual’s response to a medication cannot be predicted with certainty. It is extremely difficult to determine whether SSRI medications increase the risk for completed suicide, especially because depression itself increases the risk for suicide and because completed suicides, especially among children and adolescents, are rare. Most controlled trials are too small to detect for rare events such as suicide (thousands of participants are needed). In addition, controlled trials typically exclude patients considered at high risk for suicide.

One major clinical trial, the NIMH-funded Treatment for Adolescents with Depression Study (TADS)2, has indicated that a combination of medication and psychotherapy is the most effective treatment for adolescents with depression. The clinical trial of 439 adolescents ages 12 to 17 with MDD compared four treatment groups—one that received a combination of fluoxetine and CBT, one that received fluoxetine only, one that received CBT only, and one that received a placebo only. After the first 12 weeks, 71 percent responded to the combination treatment of fluoxetine and CBT, 61 percent responded to the fluoxetine only treatment, 43 percent responded to the CBT only treatment, and 35 percent responded to the placebo treatment.

At the beginning of the study, 29 percent of the TADS participants were having clinically significant suicidal thoughts. Although the rate of suicidal thinking decreased among all the treatment groups, those in the fluoxetine/CBT combination treatment group showed the greatest reduction in suicidal thinking.

Researchers are working to better understand the relationship between antidepressant medications and suicide. So far, results are mixed. One study, using national Medicaid files, found that among adults, the use of antidepressants does not seem to be related to suicide attempts or deaths. However, the analysis found that the use of antidepressant medications may be related to suicide attempts and deaths among children and adolescents.3

Another study analyzed health plan records for 65,103 patients treated for depression.4 It found no significant increase among adults and young people in the risk for suicide after starting treatment with newer antidepressant medications.

A third study analyzed suicide data from the National Vital Statistics and commercial prescription data. It found that among children ages five to 14, suicide rates from 1996 to 1998 were actually lower in areas of the country with higher rates of SSRI antidepressant prescriptions. The relationship between the suicide rates and the SSRI use rates, however, is unclear.5

New NIMH-funded research will help clarify the complex interplay between suicide and antidepressant medications. In addition, the NIMH-funded Treatment of Resistant Depression in Adolescents (TORDIA) study, will investigate how best to treat adolescents whose depression is resistant to the first SSRI medication they have tried. Finally, NIMH also is supporting the Treatment of Adolescent Suicide Attempters (TASA) study, which is investigating the treatment of adolescents who have attempted suicide. Treatments include antidepressant medications, CBT or both.

Complete list of all NIMH Clinical Trials.
Bridge JA, Iyengar S, Salary CB, Barbe RP, Birmaher B, Pincus HA, Ren L, Brent DA, MD. Clinical Response and Risk for Reported Suicidal Ideation and Suicide Attempts in Pediatric Antidepressant Treatment: A Meta-analysis of Randomized Controlled Trials. JAMA. 2007;297:1683-1696.
Treatment for Adolescents with Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents with Depression Study (TADS) randomized controlled trial. Journal of the American Medical Association, 2004 Aug 18; 292(7):807-20.
Olfson M, Marcus SC, Shaffer D. Antidepressant Drug Therapy and Suicide in Severely Depressed Children and Adults. Archives of General Psychiatry. 2006 Aug. 63:865-72
Simon GE, Savarino J, Operskalski B, Wang P. Suicide Risk During Antidepressant Treatment. American Journal of Psychiatry. 2006. 163 (1): 41-47.
Gibbons RD, Hur K, Bhaumik DK, Mann JJ. The relationships between antidepressant prescription rates and rate of early adolescent suicide. American Journal of Psychiatry 2006. 163 (11): 1898-1904
Source: http://www.nimh.nih.gov

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THE AUTHOR, Lawrence Stevens, is a lawyer whose practice has included representing psychiatric “patients”. His pamphlets are not copyrighted. You are encouraged to make copies for distribution to those who you think will benefit.

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If you need specific advice about how to stop taking one or more psychiatric drugs, this is the book to read. In this respect, this book fills in a gap left in other books by Dr. Peter Breggin I have read, including Psychiatric Drugs: Hazards to the Brain (1983), Toxic Psychiatry (1991), and Talking Back to Prozac (1998). In this book Drs. Breggin & Cohen also make clear they think the concept of “mental illness” is erroneous. For example, they repeatedly put the term mental illness in mocking quotation marks. They state clearly that in their opinion you are better off without psychiatric drugs, whatever your “psychiatric problem” may be: depression, manic-depressive mood swings, anxiety attacks, “schizophrenia” or psychosis, or anything else.
In this book Drs. Breggin & Cohen review the reasons you should not be taking any kind of psychiatric drug:
“No psychiatric drug has ever been tailored to a known biochemical derangement. … no biochemical imbalances have ever been documented with certainty in association with any psychiatric diagnosis. The hunt goes on for these illusive imbalances; but their existence is pure speculation, inspired by those who advocate drugs” (p. 35).
“Although medication advocates often speak with seeming confidence about how psychiatric drugs can correct biochemical imbalances in the brain, they are merely indulging in pure speculation. There’s little evidence for the existence of any such imbalances and no way to demonstrate how drugs would affect them if they did exist” (p. 34).
“Often, patients are told, ‘It’s biological and genetic.’ Never mind that there’s no substantial evidence that any psychiatric diagnoses have a physical basis” (p. 93).
“Precisely because there is so little scientific backing for the use of psychiatric drugs, mystification and slogans are often communicated to doctors by drug advertising, and then to patients by doctors” (p. 112-123, underline added).
“Indeed, we should suspect that any psychoactive drug – any drug that affects mental function – tends to produce irreversible changes in some if not most people. What hope can we have that bathing the brain in a psychiatric drug will actually improve the overall function of this mysterious organ? Almost none. In fact … most of what we know about the various neurotransmitters has been gathered by studying how psychiatric drugs disrupt or spoil their functioning” (p. 9 – underline added).
“Advocates of psychiatric drugs often claim that the medications improve learning and the ability to benefit from psychotherapy, but the contrary is true. There are no drugs that improve mental function, self-understanding, or human relations. Any drug that affects mental processes does so by impairing them” (p. 97-98).
“Despite a hugely successful promotional campaign by drug companies and biological psychiatry, the effectiveness of most or all psychiatric drugs remains difficult to demonstrate. The drugs often prove no more effective than sugar pills, or placebos – and to accomplish even these limited positive results, the clinical trials and data that they generate typically have to be statistically manipulated” (p. 37).
“But isn’t psychiatry science? Isn’t faith in psychiatry based on facts? On research? Can’t we ‘trust in research’? The sad truth is that, in the field of psychiatry, it is impossible to ‘trust in research.’ Nearly all of the research in this field is paid for by drug companies and conducted by people who will ‘deliver’ in the best way possible for those companies. … Sadly, even well-informed people too often put their faith in psychiatry and psychiatric research. It is the same as putting their faith in a drug company” (p. 189-190).
“…emotional suffering cannot be dulled without harming other functions such as concentration, alertness, sensitivity, and self-awareness” (p. 36).
“All psychiatric drugs can cause problems during withdrawal” (p. 16). And the longer you take a psychiatric drug, the more difficult your withdrawal will be.
“…many adverse drug effects are difficult to distinguish from emotional problems” (p. 24).
“Contrary to claims, neuroleptics have no specific effects on irrational ideas (delusions) or perceptions (hallucinations). Like all other psychiatric drugs, they have the same impact on healthy animals, healthy volunteers, and patients – namely, the production of apathy and indifference” (p. 77).
Neuroleptic drugs cause brain damage evidenced by a movement disorder called tardive dyskinesia, but “Neuroleptics actually suppress the symptoms of tardive dyskinesia while the disease is developing. … The rates of TD [tardive dyskinesia] are extremely high. Many standard textbooks estimate a rate of 5% – 7% per year in healthy young adults [who are taking neuroleptic drugs]. The rate is cumulative so that 25% – 35% of patients [taking neuroleptics] will develop the disorder in 5 years of treatment. Among the elderly [taking neuroleptics], rates of TD reach 20% or more per year. For a variety of reasons, including the failure to include tardive akathisia in estimates, the actual rates are probably much higher for all patients” (p. 78).
So-called antipsychotic or neuroleptic drugs cause a fatal disease called neuroleptic malignant syndrome in up to 2.4% of people taking them. “Using a low-end rate of 1 percent, Maxmen and Ward (1995, p. 33) estimate that 1,000 – 4,000 deaths occur in America each year as a result of neuroleptic malignant syndrome. The actual number is probably much greater” (p. 79).
Neuroleptic, also known as antipsychotic or major tranquilizer drugs “subject almost every system in the body to impairment. Research, including a recent study, indicates that these drugs are toxic to cells in general” (p. 81).
Clozaril … was banned in some European countries because it caused so many fatalities; but the escalating power of drug companies subsequently led to its approval by the FDA” in the United States (p. 82).
If you are pregnant, psychiatric drugs you take will cross into the baby’s bloodstream “and from there, to enter the unborn infant’s brain. Similarly, psychiatric drugs enter the mother’s milk and thus also affects the nursing infant’s brain” (p. 26).
“…women who take lithium during pregnancy expose their infants to an increased rate of heart defects” (p. 26).
“Some physicians try to reassure pregnant or nursing mothers about their baby’s safety while they are taking psychiatric drugs. But there is no scientific basis for offering this reassurance in regard to any drug that affects the brain” (p. 84).
This book is a well-documented, well-written, recent (1999), exposé of the health care quackery called biological psychiatry, particularly psychiatric drugs.
On specifically how to go about stopping taking psychiatric drugs, Drs. Breggin & Cohen say “The general rule recommended by some practitioners is to taper off in 10 percent decrements – usually every seven to ten days” (p. 126). That means you do it in ten separate steps. They suggest the last ten percent may need to be divided into a series of smaller steps and that if you are an older person who has “been taking tranquilizers daily for over twenty years … a withdrawal period of two years is not unusual” (p. 137). If you are taking more than one psychiatric drug each day, they recommend going off the drugs one at a time, that is, continuing your usual dose of your other drugs while you taper off one of them. How do you decide which drug to discontinue first? They say if “you’re taking drug ‘A’ to counteract the side effects of drug ‘B’ … you should probably start withdrawal with drug ‘B’” (p. 136). While they recommend you withdraw from psychiatric drugs with the help of a health care professional, they acknowledge that “most people who come off psychiatric drugs have successfully done so on their own, without active clinical supervision” (p. 113 – italics in original).
I was disappointed to find nothing in this book about a problem that is central to the subject of the book: forced psychiatric drugging of imprisoned or “hospitalized” persons, and the enactment of forced outpatient psychiatric drugging laws in the majority of the states of the U.S.A., exemplified by Kendra’s Law in New York. Like many of us in the ex-patient’s or “psychiatric survivor’s” movement, I was once imprisoned or “hospitalized” and forced to take a psychiatric drug – Thorazine. I was psychologically entirely normal at the time, even if I was very unhappy about the loss of the relationship with the woman I loved and about being on scholastic probation in college, leading to my parents deciding to force me into what they mistakenly thought would be “therapy”: Since I refused to seek “therapy” voluntarily, their only way to force me into “therapy” was committing me to a “hospital” against my will. The day I was incarcerated (or “hospitalized”), after the hospital staff got through asking me questions for their paperwork, I was permitted to walk around awhile in the hallways and rooms in the place I’d been imprisoned, exploring my new surroundings. But for no apparent reason, after awhile a nurse approached me with a hypodermic needle in her hand and told me she had a shot for me my doctor had prescribed for me. “I haven’t even seen a doctor” I told her. She seemed to realize I was correct, and she looked a little embarrassed when I asked the name of the doctor who had supposedly ordered the shot: She had no idea who he was. But none of that mattered to the hospital staff. She went away but was back a little while later with a large orderly, later joined by another, to force me to submit to the injection. They also did not care when I told them I hadn’t yet had a hearing or trial to determine if my commitment was justified or not, that I was being held only on a pretrial commitment order, and that it was wrong for them to force me to take a drug before I’d had a chance to go to court to present my arguments against committing or “treating” me against my will. Because of involuntary “hospitalization” laws in every state, and “outpatient commitment” laws in 40 or more states of the U.S.A. that exist for the purpose of forcing people to take psychiatric drugs or face repeated imprisonment in psychiatric “hospitals,” those of us who because of our past experience of it fear forced administration of these harmful drugs need advice about how to protect ourselves from it. All Drs. Breggin & Cohen say on this subject is: “Do not let anyone pressure you into starting or continuing psychiatric drugs. As a competent adult, you have the ethical and legal right to make your own decisions about taking psychiatric drugs. … Your decisions about taking or rejecting drugs need to be made without coercive pressure from doctors” (p. 29). While I agree with this statement, it is obvious many, apparently most, state legislators, judges, psychiatrists, and psychiatric hospital staff members do not. What us victims of psychiatry need is a strategy for avoiding forced psychiatric drugging. Drs. Breggin & Cohen do not offer one in this book.
There may not be a reliable way to protect yourself from forced psychiatric drugging, but here are two ideas: One is to hire a lawyer to write a “Declaration Regarding Mental Health Treatment,” also known as an “advance directive,” in which you say you want to receive no psychiatric drugs (or physical restraint or shock treatment) if you ever are declared mentally ill or incompetent, with a certification by a psychiatrist attached stating that you were mentally competent at the time you made the Declaration. This will undermine the argument that you would consent to “treatment” if only your thinking were not clouded by mental illness. Another strategy is to maintain a relationship with a psychiatrist who opposes coercive “treatment” who will testify for you if you become a victim of psychiatric oppression such as forced “hospitalization” or psychiatric assault such as forced psychiatric drugging. A lawyer recently advised me it probably needs to be a psychiatrist, not a psychologist. Perhaps in states where psychologists are permitted to commit people against their will, a psychologist’s testimony would be adequate.
In a rational world where human rights were respected, forced psychiatric drugging would not happen. In a rational world where human rights were respected, none of today’s psychiatric drugs would be used by anyone, voluntarily or involuntarily. Perhaps books like Your Drug May Be Your Problem will help some of us start thinking rationally about psychiatric drugs.
by
Peter R. Breggin, M.D. & David Cohen, Ph.D.
Perseus Books – Reading, Massachusetts – 1999
reviewed by Douglas A. Smith
Source: http://www.antipsychiatry.org/br-ydmby.htm

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Brand Names (generic names):

Cibalith-S (lithium)

Eskalith (lithium)

Lithane (lithium)

Lithizime (lithium)

Lithobid (lithium)

Lithonate (lithium)

Lithotabs (lithium)

Side Effects:

Acne

Birth defects if given to a

pregnant woman

Blackout spells

Blurred vision

Cardiac arrhythmia

Change in the ability to taste food

Chest tightness

Coma

Confusion

Constipation

Decreased appetite

Depression

Diabetes

Diarrhea

Difficulty thinking

Dizziness

Drowsiness

Dry mouth

Excessive saliva in the mouth

Fast, slow, irregular, or pounding heartbeat

Frequent urination

Gas

Giddiness

Hair loss

Hallucinations

Incontinence

Increased thirst

Indigestion

Insomnia

Itching

Joint or muscle pain

Lethargy

Lightheadedness

Loss of appetite

Loss of coordination

Movements that are unusual or difficult to control

Muscle weakness, stiffness, twitching, or tightness

Nausea

Painful, cold, or discolored fingers and toes

Paleness

Persistent headache

Rash

Restlessness

Ringing in the ears

Seizures

Sexual problems

Slurred speech

Stomach pain or bloating

Stupor

Swelling of the eyes, face, lips, tongue, throat, hands, wrists, feet, ankles, or lower legs

Thin, brittle fingernails or hair

Thyroid problems

Tiredness

Tongue pain

Tremors

Uncontrollable tongue movements

Unusual discomfort in cold temperatures

Vomiting

Weight gain or loss 137

General Warnings And Studies On Lithium:

Lithium is a mineral given in salt form. It is found in tiny amounts in minerals, water, plant, animal and human tissues. However, just because it is a naturally occurring substance, do not make the mistake of thinking it is safe.

One of the most dangerous effects of lithium prescribed to patients is that in order to achieve a “sedating” effect, the “therapeutic” dosage that psychiatrists use is near toxic; i.e., so poisonous that it can cause serious harm or even death.135

Medical experts state that the almost inevitable result of lithium not being metabolized is that it can lead to kidney damage. Lithium is even more hazardous when too much of it accumulates in the body and the toxicity from this can also lead to permanent brain damage and death.136

References

135 “Xanax addiction extremely tough to kick,” MSNBC News Online, 2001.

136 Statement by Joseph A. Califano, Jr., Chairman and President, “Under the Counter: The Diversion and Abuse of Controlled Prescription Drugs in the U.S.” The National Center on Addiction and Substance Abuse at Columbia University, July 2005.

137 Physicians’ Desk Reference, (Medical Economics Company, New Jersey, 1998), pp. 2822-2823; David L. Richman, M.D., Leonard

Source:http://www.cchrint.org/pdfs/The_Side_Effects_of_Common_Psychiatric_Drugs.pdf

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Brand Names (generic names):

Amytal (amobarbital)

Butalan (butabarbital)

Butisol (butabarbital)

Luminal (phenobarbitone)

Mebaral (mephobarbial)

Nembutal (pentobarbital)

Seconal (secobarbital)

Sodium Amytal (amobarbital)

Solfoton (phenobarbital)

Tuinal (secobarbital and amobarbital)

Side Effects:

Addiction

Breathing difficulties

Chronic tiredness

Depression

Disorientation

Dizziness

Fever

Hallucination

Kidney disease

Lack of coordination

Liver disease

Menstrual irregularities

Rash

Slowed reflexes & response

Sluggishness

Tightness in chest

Upset stomach

Vision problems

Swelling of eyelids, face, or lips

Barbiturates are prescribed for anxiety, depression and insomnia. However, they are infrequently used today, replaced by tranquilizers. They are highly dangerous because of the small difference between a normal dose and an overdose. The lethal dosage of barbiturates varies greatly with tolerance from one individual to another.

Barbiturate intoxication symptoms include: respiratory depression, lowered blood pressure, fatigue, fever, unusual excitement, irrational, dizziness, poor concentration, sedation, confusion, impaired coordination, impaired judgment, addiction and respiratory arrest that may lead to death.

Withdrawal Effects include elevated blood pressure and pulse, sweating, tremors, and possible seizures.

Source:http://www.cchrint.org/pdfs/The_Side_Effects_of_Common_Psychiatric_Drugs.pdf

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• The Side Effects Of Common Psychiatric Drugs: Antipsychotics (0)
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(Called Major Tranquilizers or Neuroleptics)

Brand Names (Generic Names):

Older Antipsychotics

Compazine (prochlorperazine)

Haldol (haloperidol)

Largactil (clorpromazine)

Lidone (molindone)

Loxitane (loxapine)

Mellaril (thioridazine hydrochloride)

Moban (molindone hydrochloride)

Navane (thiorixene)

Novo-Trifluzine (trifluoperazine)

Nozinan (methotrimeprazine)

Orap (pimozide)

Permitil (fluphenazine)

Phenergam (promethazie)

Proketazine (carphenazine)

Prolixin (fluphenazine hydrochloride)

Repoise (butaperazine Maleate)

Serentil (mesoridazine besylate)

Sparine (promazine)

Stelazine (trifluoperazine)

Stemetil (prochlorperazine)

Taractan (chlorprothixene)

Thorazine (chlorpromazine)

Tindal (acetophenazine)

Trancopal (chlormezanone)

Trilafon (perphenazine)

Vesprin (triflupromazine)

Newer Atypical Antipsychotics

Abilify (aripiprazole)

Clozaril (clozapine)

Geodon (ziprasidone hydrochloride)

Invega (palperidone)

Leponex (clozapine)

Risperdal (risperidone)

Serlect (sertindole)

Seroquel (quetiapine)

Symbyax (fluoxetine and olanzapine –antidepressant/antipsychotic mix)

Zeldox (ziprasidone)

Zyprexa (olanzapine)

Side Effects:

Abnormal gait (manner of walking)

Agitation

Akathisia*

Anxiety

Birth defects

Blood disorders

Blood-sugar abnormalities

Blurred vision

Breastmilk production

Cardiac arrest

Changes in behavior

Chest pain

Confusion

Constipation

Death from liver failure

Decreased sexual interest or ability

Depression

Diabetes

Diarrhea

Difficulty breathing, swallowing or fast

breathing

Difficulty falling asleep or staying asleep

Difficulty urinating or loss of bladder control

Dizziness

Dreaming more than usual

Drowsiness

Dry mouth

Dry or discolored skin

Excess sweating

Excessive weight gain

Extreme inner anxiety

Eye pain or discoloration

Fainting

Fast, irregular, or pounding

heartbeat

Fatal blood clots

Fever

Fine worm-like tongue movements

Flu-like symptoms

Headache

Heart arrhythmia

Heart failure

Heart palpitation

Heartburn

Heat stroke

Hemorrhage

High fever

Hives

Hostility

Hyperglycemia (abnormally high blood sugar)

Hypoglycemia (abnormally low blood sugar)

Impotence

Increased appetite

Increased salivation

Indigestion

Insomnia

Involuntary movements

Itching

Jaw, neck, and back muscle spasms

Joint pain

Lack of energy

Light-headedness

Loss of appetite

Manic reaction

Mood changes

Muscle or joint stiffness, pain, or weakness

Muscle twitching

Nausea

Nervousness

Neuroleptic Malignant Syndrome*

Nightmares

Pacing

Pain in arms, legs, back, or joints

Pain in the upper right part of the stomach

Painful erection that lasts for hours

Painful skin rashes

Pancreatitis (inflammation of pancreas, a gland near the stomach that helps digestion)

Poor concentration

Restlessness or pacing

Seizures or convulsions

Sexual dysfunction

Shakiness

Shaking hands that you cannot control

Sleepiness

Slow or difficult speech

Slow, jerky movements

Sore throat

Spasms

Suicidal thoughts

Swelling of the arms, hands, feet, ankles, or lower legs

Swollen and leaking breasts

Tachycardia (heart irregularity)

Tardive Dyskinesia*

Tremors

Unusual behavior

Unusual bleeding or bruising

Unusual tiredness

Violence

Vomiting

Weakness

Weight gain

Yellowing of the skin or eyes86

GENERAL WARNINGS AND STUDIES ON ANTIPSYCHOTICS:

2001: The Journal of Toxicology reported that the newer antipsychotics “will soon account for the majority of poisonings from antipsychotic agents that get presented to health care facilities in the U.S.”90 Researchers found, “[T]he ingestion of a single tablet of clozapine (Clozaril), olanzapine (Zyprexa) and risperidone (Risperidal) may cause significant toxicity in a toddler. Ataxia (involuntary muscular movement), confusions, EPS (extrapyramidal symptoms – nerve damage), coma and respiratory arrest have been reported following ingestion of 50-200 mg of clozapine in toddlers.”91

September 2003: The FDA requested the makers of six newer antipsychotic drugs add a caution to their labeling language about the potential risk of diabetes and blood sugar abnormalities.92

June 2004: The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin reporting that the newer antipsychotics could increase the risk of diabetes.93

September 22, 2005: Dr. Jeffrey Lieberman of Columbia University and other researchers published a study in The New England Journal of Medicine that compared the older generation of antipsychotics with several newer ones. Far from proving effectiveness, of the 1,493 patients who participated, 74% discontinued taking antipsychotic drugs before the end of their treatment due to inefficacy, intolerable side effects or other reasons. After 18 months of taking Zyprexa, 64% of the patients stopped taking it—most commonly because it caused sleepiness, weight gain or neurological symptoms like stiffness and tremors.94

December 1, 2005: Researchers found that 18% of nearly 23,000 elderly patients taking the older antipsychotics died within the first six months of taking them.95

May 2, 2006: USA Today released the results of an analysis of FDA data that showed at least 45 children died between 2000 and 2004 from the side effects of antipsychotic drugs (Clozaril, Risperdal, Zyprexa, Seroquel, Abilify and Geodon). Despite an adults-only FDA approval for these drugs, according to USA Today, up to 2.5 million children were prescribed them. As the FDA’s Adverse Drug Reactions reporting database only collects 1% to 10% of drug-induced side effects and reported deaths, the true child death rate could be between 450 and several thousand. Further, there were 1,328 reports of other side effects, some life-threatening, such as convulsions and low white blood cell count.96

January 5, 2008: The Lancet (Britain) published a study where the authors concluded “that the routine prescription of antipsychotic drugs early in the management of aggressive challenging behavior, even in low doses, should no longer be regarded as a satisfactory form of care.”97

April 2008: The American Geriatrics Society published a study entitled, “Antipsychotic Drug Use and Risk of Pneumonia in Elderly People,” which reviewed 22,944 elderly people with at least one antipsychotic prescription. The results of the study showed that “antipsychotics were associated with an almost 60% increase in the risk of pneumonia…” concluding that elderly people are at greater risk of pneumonia, especially during the first week of antipsychotic drug treatment.98

April 9, 2008: Pharmacoepidemiology and Drug Safety published a study entitled, “The use of central nervous system [CNS] drugs and analgesics [painkillers] among very old people with and without dementia.” The study compared the use of CNS drugs in people aged 85 years or older, with and without dementia and concluded: “[T]he use of antipsychotics in people with dementia should arouse particular concern, because of the high risk of severe adverse events and the limited evidence of positive effects.”99

May 26, 2008: The Archives of Internal Medicine published a study about “Antipsychotic

Therapy and Short-term Serious Events in Older Adults With Dementia” that found:

“Serious events…are frequent following the short-term use of antipsychotic drugs in

older adults with dementia. Antipsychotic drugs should be used with caution even when

short-term therapy is being prescribed.”100

June 2008: The FDA issued a warning to healthcare professionals that conventional and

atypical antipsychotics are associated with an increased risk of mortality in elderly patients

treated for dementia-related psychosis. It specified that antipsychotics are not indicated

for the treatment of this condition. Additionally, the FDA required the manufacturers of

these drugs to add a boxed warning about this risk to the prescribing information. Older,

conventional antipsychotics were also to carry a “black box” warning about an increased

risk of death in some elderly people.101

April 2009: The Irish Medicines Board published in their Drug Safety Newsletter, a warning

about antipsychotics causing a risk of stroke and now increased risk of mortality in elderly

patients treated for dementia. This risk covers both typical and atypical antipsychotics.102

WARNINGS ON SPECIFIC ANTIPSYCHOTICS:

ABILIFY (aripiprazole):

Abilify and other antipsychotic drugs have caused a potentially fatal condition called

neuroleptic malignant syndrome. Patients who develop this may have high fevers, muscle

rigidity, altered mental status, irregular pulse or blood pressure, rapid heart rate, excessive

sweating, and heart arrhythmias (irregularities).103

Body temperature regulation—disruption of the body’s ability to reduce core body

temperature—has been attributed to antipsychotic agents such as Abilify.104

April 2003: The U.S. consumer advocacy group Public Citizen conducted a review of

information published on Abilify, basing their evaluation primarily on publicly available

FDA reviews of information submitted by the manufacturer to gain FDA approval for

Abilify. Approval was based on five trials only lasting four to six weeks. According to

Public Citizen, “…nothing in these five trials can lead one to believe that aripiprazole

(Abilify) is a meaningful advancement in the treatment of schizophrenia.”105

The information insert on Abilify lists hyperglycemia (abnormally high blood sugar—

usually associated with diabetes), hypoglycemia (abnormally low blood sugar) and diabetes

as possible side effects.106

Clozaril (clozapine):

May 2008: Medsafe (New Zealand) posted a prescriber update called “Clozapine and

Achy Breaky Hearts” warning that clozapine can cause myocarditis [inflammation of the

heart muscle] that may be fatal. It was also associated with cardiomyopathy [disease of

the heart muscle]. While risk factors are unknown, pre-treatment cardiovascular screening

was recommended.107

May 2008: Medsafe posted their June 2008 “Watching Briefs,” a report in which they

included a warning: “Use of clozapine in older patients carries a higher risk of adverse

reactions such as postural hypotension [low blood pressure], falls, sedation and constipation,

compared to use in younger patients. Therefore, increased clinical monitoring of the elderly

is necessary to ensure their safety.”108

Haldol (haloperidol):

September 17, 2007: The FDA issued an alert to Healthcare Professionals about

haloperidol (marketed as Haldol), stating: “Due to a number of case reports of sudden

death, TdP [Torsades de Pointes] and QT prolongation [TdP and QT prolongation are types

of heart abnormalities] in patients treated with haloperidol (especially when the drug is

given intravenously or at doses higher than recommended), the sponsor has updated the

labeling for haloperidol.” ECG (Electrocardiogram—a graphical recording of the cardiac

cycle produced by a special machine, a.k.a. EKG) monitoring was recommended if

haloperidol is given intravenously, even though haloperidol is not approved for intravenous

administration.109

ZYPREXA (olanzapine):

July 22, 2005: Eli Lilly & Co., the manufacturer of Zyprexa, agreed to pay $1.07 billion

to settle more than 8,000 claims against the drug, alleging it could potentially cause lifethreatening

diabetes.110

September 22, 2005: Dr. Jeffrey Lieberman of Columbia University and other researchers

published a study in The New England Journal of Medicine comparing an older generation

of antipsychotics with several newer ones.111 After 18 months of taking Zyprexa, 64%

of the patients stopped taking it, most often because it was not well tolerated and caused

sleepiness, weight gain or neurological symptoms like stiffness and tremors.112

October 5, 2007: Eli Lilly issued an important Safety Information update on its website

and product labels for Zyprexa and Symbyax (combination of Zyprexa and fluoxetine, or

Prozac) warning of the risk of weight gain, hyperglycemia (increased blood sugar) and

hyperlipidemia (elevated fats in the blood and cholesterol).113

2008: The current Zyprexa Safety Information includes a “black box” warning of increased

risk of death in elderly patients with dementia, as well as the following warnings: High

level of fats in the blood, weight gain, high blood sugar, strokes and “mini strokes” (in

elderly people with dementia), neuroleptic malignant syndrome, tardive dyskinesia, low

blood pressure, trouble with judgment, thinking, and reflexes, trouble swallowing, body

temperature problems…and “this is not a complete list….”114

*Akathisia: A, meaning “without” and kathisia, meaning “sitting,” an inability to keep still. Patients

pace about uncontrollably. The side effect has been linked to assaultive, violent behavior.87

*Neuroleptic malignant syndrome: A potentially fatal toxic reaction where patients break into

fevers and become confused, agitated and extremely rigid. An estimated 100,000 Americans have

died from it after taking the older antipsychotics.88

*Tardive Dyskinesia: Tardive, meaning “late” and dyskinesia meaning, “abnormal movement of

muscles.” Tardive Dyskinesia is a permanent impairment of the power of voluntary movement of

the lips, tongue, jaw, fingers, toes and other body parts.89

References

1 Physicians’ Desk Reference, http://www.pdrhealth.com; “Adderall,” DrugStore.com, Internet URL: http://www.drugstore.com;

“Study Suggests Focalin (TM) LA Capsules (d-MPH-ER) Are Safe and Effective for ADHD in Adults,” PR Newswire, 5 May 2004;

A.D.D. Warehouse website; ADHDHelp, Internet URL: http://www.adhdhelp.org/metadate.htm. Journal of the Royal Society of Med.,

Vol 92, Mar. 99 “letters to the editor” p. 156. Medline Plus, www.nim.nih.gov/medlineplus: Millichap, J.Gordon “Methylphenidate

Role in Tourettes Syndrome Prevalence.

2 Diagnostic and Statistical Manual of Mental Disorders (DSM-III-R), American Psychiatric Association, Washington, D.C., 1987, p. 136.

3 “Drug Scheduling,” U.S. Drug Enforcement Administration Online, Internet URL: http://www.dea.gov.

4 Raul R. Gainetdinov; William C. Wetsel; Edward D. Sara; R. Levin Jones; Mohamed Jaber; Marc G. Caron, “Role of Serotonin in the

Paradoxical Calming Effect of Psychostimulants on Hyperactivity,” Science, 15 Jan. 1999.

5 “Statement on Concerta and Methylphenidate,” Statement posted on the FDA website, 28 June 2005.

6 Marian S. MacDonagh, PharmaD, and Kim Peterson, MS, “Drug Class Review on Pharmacologic Treatment for ADHD: Final

Report,” Oregon Health and Science University, Sept. 2005, pp. 13-20.

7 “FDA will study safety of attention-deficit drugs,” Kansas City Star, 5 Jan. 2006.

8 “Stimulants in children with ADHD may have negative CV effect,” Mental Health Law Weekly, 4 Feb. 2006.

9 Ricardo Alonso-Zaldivar, “Warning Urged for ADHD Drugs,” Los Angeles Times, 10 Feb. 2006.

10 Todd Zwillich, “FDA Panel Recommends Warnings of Rare Reports of Aggressive Behavior or Psychotic Symptoms,” WebMD, 23

Mar. 2006.

11 “Dark side of a wonder drug,” The Australian, 28 Mar. 2006.

12 Almut G. Winterstein, et al., “Cardiac Safety of Central Nervous System Stimulants in Children and Adolescents With Attention-

Deficit/Hyperactivity Disorder,” Pediatrics, Vol. 120, Dec. 2007, pp. e1494-e1501.

13 W. Goldman, et al., “Association between treatment with central nervous system stimulants and Raynaud’s Syndrome in children: a

study of rheumatology patients,” Arthritis & Rheumatism, Vol. 58, No. l, 2 Feb. 2008, pp. 563-566.

14 Brian Vastig, “Pay Attention: Ritalin Acts Much Like Cocaine,” JAMA, 22/29 Aug. 2001, Vol. 286, No. 8, p. 905.

15 Joel Turtel, Public Schools, Public Menace: How Public Schools Lie to Parents and Betray Our Children, (Library Books, New

York), 2004-2005, p. 135.

16 “Partnership Attitude Tracking Study” of teens in 2004, 17th Annual report by Partnership for a Drug-Free America, 21 Apr. 2005;

“Survey: 1 in 5 teens getting high on medications, over-counter drugs,” NewsItem.com, 2 May 2005.

17 Larry A. Kroutil, et al., “Nonmedical use of prescription stimulants in the United States,” Drug and Alcohol Dependence, Feb. 2006.

18 Brian Witte, “Slaying blamed on reaction to hyperactivity drug,” Associated Press, 25 Oct. 1999.

19 “J & J Psychiatric Safety Labeling, Cardiovascular Events Are Topic For Cmte,” FDAAdvisoryCommittee.com, June 2005.

20 “Health Canada Suspends Marketing of Adderall,” FDA Alert, 9 Feb. 2005.

21 “Health Canada allows Adderall XR® back on the Canadian market,” Health Canada News Release, 24 Aug. 2005.

22 Partnership Attitude Tracking Study, Teens – 2004, Partnership for a Drug-Free America, 21 Apr. 2005, p. 7; “Cylert recall

demanded over safety concerns,” Lifestyle News, www.mynippon.com/news/2005/03/cylert-recall-demanded-over-safety-concerns.

23 “Injured by Cylert?” Parker Waichman Alonso, LLP, http://www.yourlawyer.com/topics/overview/cylert.

24 “FDA Withdraws Approval for ADD Drug,” Associated Press, 24 Oct. 2005.

25 “Updated Safety Information: Warnings regarding serious rash, including Stevens-Johnson Syndrome and hypersensitivity reactions,

and psychiatric symptoms,” Cephalon, Inc., Sept. 2007.

26 Op. cit., DSM-III-R, pp. 136, 175.; Medical Economics Company, Physicians Desk Reference (Montvale, NJ: Medical Economics

Co, 1998), pp. 1,897.

27 “Methylphenidate (A Background Paper),” U.S. Drug Enforcement Administration, Oct. 1995, p. 16.

28 “Antidepressant Ritalin to be delisted because of abuse,” Daily Yomiuri Online, 19 Oct. 2007.

29 Ritalin Drug Label, fda.gov.

30 Physicians’ Desk Reference, http://www.pdrhealth.com; Joseph Glenmullen, M.D. Prozac Backlash, (Simon & Schuster, New York,

2000), p. 8; “Antidepressants Lift Clouds, But Lost ‘Miracle Drug’ Label,” The New York Times, 30 June 2002; Alice Park, “More

Drugs To Treat Hyperactivity,” TIME Magazine, 10 Sept. 2001; Wellbutrin/Bupropion, Prozac Truth website; “Teen Suffers Seizure

After Snorting Antidepressant,” HealthScoutNews Reporter, 23 Apr. 2003.

31 Dr. Candace B. Pert, Letter to the Editor, TIME Magazine, 20 Oct. 1997, p. 8.

32 “Worsening Depression and Suicidality in Patients Being Treated with Antidepressant Medication,” FDA Public Health Advisory, 22

Mar. 2004.

33 Gardiner Harris, “Antidepressant Study Seen to Back Expert,” The New York Times, 20 Aug. 2004.

34 “Antidepressant aggression concern,” BBC News Online, 21 Sept. 2004.

35 “Suicidality in Children and Adolescents Being Treated With Antidepressant Medications,” FDA Public Health Advisory, 15 Oct. 2004.

36 “New advice on prescribing anti-depressants,” New Zealand Ministry of Health Media Release, 21 Oct. 2004.

37 “Use of SSRI antidepressants in children and adolescents,” Australian Adverse Drug Reactions Bulletin, Vol. 23, No. 6, Dec. 2004.

38 “European Medicines Agency finalises review of antidepressants in children and adolescents,” European Medicines Agency Press

Release, 25 Apr. 2005.

39 Sarah Boseley, “Suicide fear from antidepressants,” The Guardian (London), 18 Feb. 2005.

40 Joanna Moncrieff and Irving Kirsch, “Efficacy of Antidepressants in Adults,” British Medical Journal, Vol. 331, 16 July 2005, pp.

155-157; Salynn Boyles, “Battle Brews Over Antidepressant Use,” Fox News, 15 Jul. 2005.

41 “Suicidality with SSRIs: adults and children,” Australian Adverse Drug Reactions Bulletin, Vol. 24, No. 4, Aug. 2005.

42 “Annex II,” Commission Decision of 19-VIII-2005, Commission of the European Communities, 19 Aug. 2005.

43 Ivar Aursnes, et al., “Suicide Attempts in Clinical Trials with Paroxetine Randomised Against Placebo,” BMC Medicine, Vol. 3, pp.

14-18.

44 Sheryl Ubelacker, “SSRI antidepressants may raise suicide risk in elderly patients: study,” Sympatico, 1 May 2006.

45 “Antidepressants should list new risks: FDA,” Reuters, 19 July 2006; “Combined Use of 5-Hydroxytryptamine Receptor Agonists (Triptans), Selective Serotonin Reuptake Inhibitors (SSRIs) or Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs) May

Result in Life-threatening Serotonin Syndrome,” FDA Public Health Advisory, 19 July 2006.

46 “FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressants,” FDA News, 2 May 2007.

47 “Antidepressants and suicidal thoughts and behaviour,” Pharmacovigilance Working Party, Jan. 2008.

48 Yan Chen, et al., “Risk of Cerebrovascular Events [CVE] Associated with Antidepressant Use in Patients with Depression: A

Population-Bases, Nested Case-Control Study,” The Annals of Pharmacotherapy, Vol. 42, No. 2, pp. 177-184, 22 Jan. 2008.

49 “Implementation of warnings on suicidal thoughts and behaviour in antidepressants,” MHRA, 5 February 2008.

50 Irving Kirsch, et al., “Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug

Administration,” Public Library of Science, Vol. 5, Iss. 2, 26 Feb. 2008.

51 “Antidepressant drug use and risk of venous thromboembolism,” Pharmacotherapy, Vol. 28, No. 2, 28 Feb. 2008.

52 Thomas Laughren, M.D., Letter to GlaxoSmithKline Attn: Randal L. Batenhorst, Food and Drug Administration, Jan. 2009.

53 Benedict Carey, “Treatment of Depression in Pregnancy Affects Babies,” The New York Times, 4 Feb. 2005.

54 “General information concerning use of SSRI antidepressants in pregnant women,” Therapeutic Goods Administration, 7 Sept. 2005.

55 “Paroxetine HCL – Paxil and generic paroxetine,” 2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary

Supplements, FDA MedWatch, 27 Sept. 2005.

56 Steve Mitchell, “Analysis: SSRIs’ risk to infants,” United Press International, 6 Feb. 2006.

57 “Advisory – Newer antidepressants linked to serious lung disorder in newborns,” Health Canada press release, 10 Mar. 2006.

58 Maria Bishop, “Use of Antidepressants in Pregnancy Affects Neonatal Outcomes: Presented at AACAP,” Doctor’s Guide, 29 Oct.

2007.

59 “Paxil, Prozac, Zoloft and Other SSRI Antidepressants Tied to Premature Birth,” News Inferno, 6 May 2008.

60 “Duloxetine hydrochloride (marketed as Cymbalta) information,” FDA information sheet, 30 June 2005.

61 “Cymbalta (duloxetine hydrochloride),” 2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements, FDA

MedWatch, 17 Oct. 2005.

62 “NDA # 21-733. CYMBALTA® (duloxetine hydrochloride) Delayed-release Capsules. MACMIS # 14550,” FDA, 2 Oct. 2007.

63 “Paroxetine,” FDA Public Health Advisory, 8 Dec. 2005.

64 Benedict Carey and Gardiner Harris, “Antidepressant May Raise Suicide Risk,” The New York Times, 12 May 2006.

65 Corrado Barbui, M.D., et al., “Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic reexamination

of published and unpublished data from randomized trials,” Canadian Medical Association Journal, Vol. 178, No. 3, 29

Jan. 2008.

66 “New Warning for Strattera,” FDA Talk Paper, 17 Dec. 2004.

67 “Attention Drug to Get New Warning,” Los Angeles Times, 18 Dec. 2004.

68 “Strattera to Get New Risk Label,” The Washington Post, 18 Dec. 2004.

69 “New Drugs in Pipeline,” Psychiatric News, 21 Dec. 2001.

70 “Lilly to add suicide warning to Strattera,” ABC News, 29 Sept. 2005.

71 “Atomoxetine and suicidal behavior: update,” Canadian Adverse Reaction Newsletter, Vol. 18, Iss. 3, July 2008.

72 “Atomoxetine: risk of psychotic or manic symptoms,” Drug Safety Update, MHRA, Vol. 2, Iss. 8, March 2009.

73 “Teen Suffers Seizure After Snorting Antidepressant,” HealthScoutNews Reporter, 23 Apr., 2003.

74 Op. cit., Prozac Truth website.

75 Alice Park, “More Drugs To Treat Hyperactivity,” TIME Magazine, 10 Sept. 2001.

76 Op. cit., Prozac Truth website.

77HealthScoutNews Reporter.

78 Op. cit. Physicians’ Desk Reference, http://www.pdrhealth.com.

79 “Suicidality in Children and Adolescents Being Treated With Antidepressant Medications,” FDA Public Health Advisory, 15 Oct.

2004.

80 Op cit.New Zealand Ministry of Health.

81 Italian Official Gazette, No. 224, 26 Sept. 2005.

82 “Depression in Children and Young People,” National Institute for Health and Clinical Excellence, Sept. 2005, pp. 16, 18 and 28.

83 FDA, “Antidepressant Use in Children, Adolescents, and Adults,” www.fda.gov/CDER/Drug/antidepressants?default.html, updated

2 May 2007.

84 Op. Cit.Maria Bishop.

85 “Antidepressant drug use and risk of venous thromboembolism,” Pharmacotherapy, Vol. 28, No. 2, 28 Feb. 2008.

86 Physicians’ Desk Reference, http://www.pdrhealth.com; “ABILIFY Rx Only (aripiprazole) Tablets,” Package Insert, revised Mar.

2004; “GENERIC NAME: Aripiprazole BRAND NAME: Abilify,” Internet URL: http://www.MedicineNet.com, Last Editorial

Review: 9/8/04; “Aripiprazole Brand Name: Abilify,” Internet URL: http://www.HealthyPlace.com, Ty C. Colbert, Rape of the Soul,

How the Chemical Imbalance Model of Modern Psychiatry has Failed its Patients, (Kevco Publishing, California, 2001), p. 106.

87 Robert Whitaker, Mad in America: Bad Science, Bad Medicine, and the Enduring Mistreatment of the Mentally Ill, (Perseus

Publishing, New York, 2002), pp. 182, 186.

88 Op. cit., Robert Whitaker, p. 208.

89 George Crane, “Tardive Dyskinesia in Patients Treated with Major Neuroleptics: A Review of the Literature,” American Journal of

Psychiatry, Vol. 124, Supplement, 1968, pp. 40-47.

90 Michael J. Burns, “The Pharmacology and Toxicology of Atypical Antipsychotic Agents,” Journal of Toxicology, 1 Jan. 2001.

91 Ibid.

92 “FDA: Antipsychotic Drugs, Diabetes Linked,” Associated Press Online, 18 Sept. 2003.

93 “Atypical antipsychotics and hyperglycaemia,” Australian Adverse Drug Reactions Bulletin, Vol. 23, No. 3, June 2004.

94 Jeffrey A. Lieberman, M.D., et al., “Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia,” The New England Journal of Medicine, Vol. 353, No. 12, 22 Sept. 2005.

95 Philip S. Wang, et al., “Risk of Death in Elderly Users of Conventional vs. Atypical Antipsychotic Medication,” The New England

Journal of Medicine, Vol. 353, No. 22, 1 Dec. 2005.

96 Marilyn Elias, “New antipsychotic drugs carry risks for children; Side effects can lead to bigger health problems,” USA Today, 2

May 2006.

97 Peter Tyrer, et al., “Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with

intellectual disability: a randomized controlled trial,” The Lancet, Vol. 371, 5 Jan. 2008.

98 Wilma Knol, M.D., et al., “Antipsychotic Drug Use and Risk of Pneumonia in Elderly People,” The American Geriatrics Society, Vol.

56, No. 4, pp. 661-666, Apr. 2008.80

99 Hugo Lovheim, M.D., Stig Karlsoon, R.N., Ph.D., et al., “The use of central nervous system drugs and analgesics among very old

people with and without dementia,” Pharmacoepidemiology and Drug Safety, 9 Apr. 2008.

100 Paula A. Rochon, M.D., MPH, FRCPC, et al., “Antipsychotic Therapy and Short-term Serious Events in Older Adults With

Dementia,” The Archives of Internal Medicine, Vol. 168, No. 10, 26 May 2008.

101 “Information for Healthcare Professionals Antipsychotics,” FDA, June 2008; “US FDA expands antipsychotic drug warning,”

Reuters UK, 17 June 2008.

102 “Update on the safety of antipsychotic medicines – risk of stroke and increased risk of mortality in elderly patients treated for

dementia,” Drug Safety Newsletter, Iss. 30, Apr. 2009, p. 5.

103 MedicineNet.com, Last Editorial Review: 9/8/04.

104 “Abilify Information,” Pharma-Help.com.

105 “The New Anti-Psychotic Drug Aripiprazole (ABILIFY),” Public Citizen’s eLetter, Apr. 2003.

106 Op. cit., “ABILIFY Rx Only (aripiprazole) Tablets,”

107 “Clozapine and Achy Breaky Hearts,” MedSafe, May 2008.

108 Watching Briefs, MedSafe, June 2008.

109 “Information for Healthcare Professionals Haloperidol (marketed as Haldol, Haldol Decanoate and Haldol Lactate),” FDA ALERT,

17 Sept. 2007.

110 Jeff Swiatek, “Uncertainty was Driver in Zyprexa Deal,” IndianapolisStar.com, 11 June 2005.

111 Op. cit., Jeffrey A. Lieberman, M.D., et al.

112 “Study: New drugs little better for schizophrenia,” St. Petersburg Times, 20 Sept. 2005.

113 “Important Safety Information about ZYPREXA® (olanzapine),” Eli Lilly and Company, 5 Oct. 2007; “Lilly Announces Updates

to the Zyprexa and Symbyax U.S. Labels,” PRNewswire, Bio-Medicine, 5 Oct. 2007.

114 ZYPREXA Safety Information, www.zyprexa.com.

115 Physicians’ Desk Reference, http://www.pdrhealth.com.

116 Tracey McVeigh, “Tranquilizers ‘more lethal than heroin,’” The Observer, 5 Nov. 2000.

117 Matt Clark, Mary Hager, “Valium Abuse: The Yellow Peril,” Newsweek, 24 Sept. 1979; Dr. Patrick Holford, “How to Quit

Tranquilizers,” www.patrickholdford.com, 2008.

118 Ibid.

119 Op. cit., Tracey McVeigh.

120 “Elderly On Long-Acting Anxiety, Insomnia Drugs Have More Car Crashes,” Doctor’s Guide citing Journal of American Medical

Association, 30 June 1997.

121 “Agression, Violence & Bezodiazapines,” Benzo.org.uk, citing British National Formulary, 2001.

122 Benzo.org.uk, citing Professor C. Heather Ashton, Benzodiazepines: How They Work and How To Withdraw, Feb. 2001.

123 “The Influence on the Pharmaceutical Industry,” House of Commons, UK, Health Committee, Vol. 1, Mar. 2005. p. 65.

124 Tarja-Brita R. Wahlin, et al., “Falls and fall risk among nursing home residents,” The Journal of Clinical Nursing, Vol. 17, pp. 126-

134, Jan. 2008.

125 “Europe-wide review recommends updates to product information for varenicline (brand name Champix),” MHRA, 14 Dec. 2008.

126 “Early Communication About an Ongoing Safety Review Varenicline (marketed as Chantix),” FDA, 20 Nov. 2007.

127 “Varenicline (marketed as Chantix) Information,” FDA Alert, 1 Feb. 2008.

128 Op. cit., House of Commons, UK, Health Committee, p. 65.

129 Anna Maria Dademan, “Flunitrazepam and violence—psychiatric and legal issues,” Department of Clinical Neuroscience,

Occupational Therapy and Elderly Care, Research Division of Forensic Psychiatry, Karolinska Institute, Sweden, 2000, p. 43.

130 “Zolpidem (‘Stilnox’) – Updated information – February 2008,” Theraputic Goods Administration, 21 Feb. 2008; “Club Drugs: An

Update,” Drug Intelligence Brief, Drug Enforcement Administration, Sept. 2001.

131 “FDA Safety Changes: Ambien, Primazin IM/IV, Hepsera,” Medscape, 28 Aug. 2008.

132 Peter Breggin, Toxic Psychiatry, (St. Martin’s Press, New York, 1991) p. 245.

133 Jerrold F. Rosenbaum, et al., “Emergence of Hostility During Alprazolam Treatment in Borderline Personality Disorder,” The

American Journal of Psychiatry, Vol. 141, No. 6 (June 1984), pp. 792-793.

134 David L. Gardner and Rex W. Cowdrey, “Alprazolam-Induced Dyscontrol in Borderline Personality Disorder,” The American

Journal of Psychiatry, Vol. 142, No. 1 (Jan. 1985), pp. 98-100.

135 “Xanax addiction extremely tough to kick,” MSNBC News Online, 2001.

136 Statement by Joseph A. Califano, Jr., Chairman and President, “Under the Counter: The Diversion and Abuse of Controlled

Prescription Drugs in the U.S.” The National Center on Addiction and Substance Abuse at Columbia University, July 2005.

137 Physicians’ Desk Reference, (Medical Economics Company, New Jersey, 1998), pp. 2822-2823; David L. Richman, M.D., Leonard

Roy Frank, and Art Mandler, Dr. Caligari’s Psychiatric Drugs (Alonzo Printing Co., Inc., California, 1984), p. 39.

138 Op. cit., David L. Richman, M.D., et al., pp. 38-39.

139 Ibid.

Source: http://www.cchrint.org/pdfs/The_Side_Effects_of_Common_Psychiatric_Drugs.pdf

Related posts

• The Side Effects Of Common Psychiatric Drugs: Newer Antidepressants (0)
• The Side Effects Of Common Psychiatric Drugs: Older Antidepressants (0)
• The Side Effects Of Common Psychiatric Drugs: Anti-Anxiety Drugs (0)
• The Side Effects Of Common Psychiatric Drugs: Lithium (0)
• The Side Effects Of Common Psychiatric Drugs: Psychostimulants (0)
• Valium (diazepam) (0)
• Sertraline (0)
• Zoloft – sertraline HCl (0)
• Tegretol (0)
• XEPLION® (paliperidone palmitate) (0)

(Including Tricyclics, Tetracyclics and MAOIs)

Brand Names (Generic Names):

Tricyclics

Adapin (doxepin)

Anafranil (clomipramine)

Asendin (amoxapine)

Aventyl (nortriptyline)

Elavil (amitriptyline)

Endep (amitriptyline)

Etrafon (amitriptyline and perphenazine)

Janimine (imipramine)

Maneon (amitriptyline)

Norpramin (desipramine hydrochloride)

Nortilen (nortriptyline)

Pamelor (nortriptyline)

Pertofrane (norpramin)

Saroten (amitriptyline)

Sinequan (doxepin hydrochloride)

SK-Pramine Oral (imipramine)

Surmontil (trimipramine maleate)

Tofranil (imipramine hydrochloride)

Triavil (amitriptyline hydrochloride

and perphenazine)

Triptazine (amitriptyline)

Triptil (protriptyline)

Tryptizol (amitriptyline)

Tryptanol (amitriptyline)

Vivactil (protriptyline hydrochloride)

Tetracyclics

Avanza (mirtazapine)

Ludiomil (maprotiline hydrochloride)

Remergil (mirtazapine)

Remeron (mirtazapine)

Tolvon (mianserin hydrochloride)

Zispin (mirtazapine)

MAOIs

Aurorix (moclobemide)

Emsam (selegiline – skin patch)

Manerix (moclobemide)

Marplan (isocarboxazid)

Nardil (phenelzine sulfate)

Parnate (tranylcypramine sulfate)

Side Effects:

Anxiousness

Black tongue

Blurred vision

Breast enlargement in men and women

Changes in appetite or weight

Changes in sex drive or ability

Cold, clammy skin

Coma

Confusion

Constipation

Crushing chest pain

Decreased memory or concentration

Delirium

Delusions

Depression

Diarrhea

Difficulty breathing or swallowing

Difficulty falling asleep or staying asleep

Difficulty thinking

Dizziness

Drowsiness

Dry mouth

Excessive sweating

Excitement or anxiety

Extreme restlessness

Eye pain

Eyes more sensitive to light than usual

Fainting

Fast, irregular, or pounding heartbeat

Flu-like symptoms, fever, chills, sore throat, or other signs of infection

Flushing

Forgetfulness

Frequent, painful, or difficult urination

Gas

Hair loss

Hallucinations

Heartburn

Hives

Hyperactivity

Itching

Jaw, neck, and back muscle spasms

Lethargy

Lightheadedness

Liver problems

Lowered white blood cell count (with risks of infection)

Manic reactions

Muscle pain or weakness

Muscle twitching or jerking

Nausea

Neck stiffness or soreness

Nervousness

Nightmares

Numbness, burning, or tingling

Panic feelings

Rash or blisters

Ringing in the ears

Sedation

Seizures

Severe headache

Severe muscle stiffness

Shakiness

Shuffling walk

Slow or difficult speech

Stomach pain or cramps

Stroke

Stuffy nose

Sudden, severe nausea and vomiting

Sweating

Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

Tightness in the chest or throat

Tiredness

Uncontrollable shaking of any part of the body

Unsteadiness

Unusual bleeding or bruising

Unusual movements that are difficult to control

Unusual taste in the mouth

Unusual tiredness or weakness

Weakness or tiredness

Widened pupils (black circles in the middle of the eyes)

Yellowing of the skin or eyes78

EXPLANATORY NOTE:

Tricyclics: (TCAs) were introduced in the late 1950s/early 60s and the name refers to the three rings in the chemical structure of the drugs.

Tetracyclics: The name derives from the drug’s molecular structure that consists of fourring- like structures in a T-shape.

MAOIs: Monoamine Oxidase Inhibitors (MAOIs). Monoamine Oxidase is an enzyme that has the function of getting rid of used neurotransmitters found in the gap between nerve cells. It was theorized (not proved) that too low concentrations of neurotransmitters may cause depression and MAOIs blocked the activity of this enzyme, resulting in higher levels of neurotransmitters (serotonin, norepinephrine and dopamine, which are all “monoamines” meaning they have a single amino acid – a compound used to form proteins that are essential for function and structure of cells in the body.)

GENERAL WARNINGS AND STUDIES ON OLDER ANTIDEPRESSANTS:

October 15, 2004: The FDA ordered pharmaceutical companies to add a “black box” warning to all antidepressants, saying the drugs could cause suicidal thoughts and actions in children and teenagers.79

October 21, 2004: The New Zealand Medicines Adverse Reactions Committee recommended that old and new antidepressants not be administered to patients less than 18 years of age because of the potential risk of suicide.80

September 26, 2005: The Italian Gazette (official news agency of the Italian government) published a resolution of the Agenzia Italiana del Farmaco (Italian Drug Agency, equivalent to the FDA) ordering a warning label for older antidepressants stating that the drugs should not be prescribed for under 18 year olds. They also determined that they were associated with heart attacks in people of any age. 81

September 28, 2005: The British National Health Service’s Institute for Health and Clinical Excellence warned that “all antidepressant drugs have significant risks when given to children and young people.” 82

May 2, 2007: The FDA told makers of all antidepressants to update the existing black box warning on their products’ labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment.83

October 2007: A study released at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry found that babies born to mothers who take antidepressant medication during pregnancy have high levels of cortisol (a hormone that helps regulate blood pressure) in umbilical cord-blood at birth, and their mothers are more likely to experience delivery complications. When examined at 2 weeks of age, the infants of women taking antidepressants were more excitable than infants born to women not taking antidepressants. 84

February 28, 2009: Pharmacotherapy published a study on “Antidepressant drug use and risk of venous thromboembolism [blockage of a blood vessel due to a clot],” which concluded, “Current exposure to amitriptyline [antidepressant], particularly at high does, was associated with an increased risk of idiopathic [of unknown cause] venous thromboembolism.”

References

1 Physicians’ Desk Reference, http://www.pdrhealth.com; “Adderall,” DrugStore.com, Internet URL: http://www.drugstore.com;

“Study Suggests Focalin (TM) LA Capsules (d-MPH-ER) Are Safe and Effective for ADHD in Adults,” PR Newswire, 5 May 2004;

A.D.D. Warehouse website; ADHDHelp, Internet URL: http://www.adhdhelp.org/metadate.htm. Journal of the Royal Society of Med.,

Vol 92, Mar. 99 “letters to the editor” p. 156. Medline Plus, www.nim.nih.gov/medlineplus: Millichap, J.Gordon “Methylphenidate

Role in Tourettes Syndrome Prevalence.

2 Diagnostic and Statistical Manual of Mental Disorders (DSM-III-R), American Psychiatric Association, Washington, D.C., 1987, p. 136.

3 “Drug Scheduling,” U.S. Drug Enforcement Administration Online, Internet URL: http://www.dea.gov.

4 Raul R. Gainetdinov; William C. Wetsel; Edward D. Sara; R. Levin Jones; Mohamed Jaber; Marc G. Caron, “Role of Serotonin in the

Paradoxical Calming Effect of Psychostimulants on Hyperactivity,” Science, 15 Jan. 1999.

5 “Statement on Concerta and Methylphenidate,” Statement posted on the FDA website, 28 June 2005.

6 Marian S. MacDonagh, PharmaD, and Kim Peterson, MS, “Drug Class Review on Pharmacologic Treatment for ADHD: Final

Report,” Oregon Health and Science University, Sept. 2005, pp. 13-20.

7 “FDA will study safety of attention-deficit drugs,” Kansas City Star, 5 Jan. 2006.

8 “Stimulants in children with ADHD may have negative CV effect,” Mental Health Law Weekly, 4 Feb. 2006.

9 Ricardo Alonso-Zaldivar, “Warning Urged for ADHD Drugs,” Los Angeles Times, 10 Feb. 2006.

10 Todd Zwillich, “FDA Panel Recommends Warnings of Rare Reports of Aggressive Behavior or Psychotic Symptoms,” WebMD, 23

Mar. 2006.

11 “Dark side of a wonder drug,” The Australian, 28 Mar. 2006.

12 Almut G. Winterstein, et al., “Cardiac Safety of Central Nervous System Stimulants in Children and Adolescents With Attention-

Deficit/Hyperactivity Disorder,” Pediatrics, Vol. 120, Dec. 2007, pp. e1494-e1501.

13 W. Goldman, et al., “Association between treatment with central nervous system stimulants and Raynaud’s Syndrome in children: a

study of rheumatology patients,” Arthritis & Rheumatism, Vol. 58, No. l, 2 Feb. 2008, pp. 563-566.

14 Brian Vastig, “Pay Attention: Ritalin Acts Much Like Cocaine,” JAMA, 22/29 Aug. 2001, Vol. 286, No. 8, p. 905.

15 Joel Turtel, Public Schools, Public Menace: How Public Schools Lie to Parents and Betray Our Children, (Library Books, New

York), 2004-2005, p. 135.

16 “Partnership Attitude Tracking Study” of teens in 2004, 17th Annual report by Partnership for a Drug-Free America, 21 Apr. 2005;

“Survey: 1 in 5 teens getting high on medications, over-counter drugs,” NewsItem.com, 2 May 2005.

17 Larry A. Kroutil, et al., “Nonmedical use of prescription stimulants in the United States,” Drug and Alcohol Dependence, Feb. 2006.

18 Brian Witte, “Slaying blamed on reaction to hyperactivity drug,” Associated Press, 25 Oct. 1999.

19 “J & J Psychiatric Safety Labeling, Cardiovascular Events Are Topic For Cmte,” FDAAdvisoryCommittee.com, June 2005.

20 “Health Canada Suspends Marketing of Adderall,” FDA Alert, 9 Feb. 2005.

21 “Health Canada allows Adderall XR® back on the Canadian market,” Health Canada News Release, 24 Aug. 2005.

22 Partnership Attitude Tracking Study, Teens – 2004, Partnership for a Drug-Free America, 21 Apr. 2005, p. 7; “Cylert recall

demanded over safety concerns,” Lifestyle News, www.mynippon.com/news/2005/03/cylert-recall-demanded-over-safety-concerns.

23 “Injured by Cylert?” Parker Waichman Alonso, LLP, http://www.yourlawyer.com/topics/overview/cylert.

24 “FDA Withdraws Approval for ADD Drug,” Associated Press, 24 Oct. 2005.

25 “Updated Safety Information: Warnings regarding serious rash, including Stevens-Johnson Syndrome and hypersensitivity reactions,

and psychiatric symptoms,” Cephalon, Inc., Sept. 2007.

26 Op. cit., DSM-III-R, pp. 136, 175.; Medical Economics Company, Physicians Desk Reference (Montvale, NJ: Medical Economics

Co, 1998), pp. 1,897.

27 “Methylphenidate (A Background Paper),” U.S. Drug Enforcement Administration, Oct. 1995, p. 16.

28 “Antidepressant Ritalin to be delisted because of abuse,” Daily Yomiuri Online, 19 Oct. 2007.

29 Ritalin Drug Label, fda.gov.

30 Physicians’ Desk Reference, http://www.pdrhealth.com; Joseph Glenmullen, M.D. Prozac Backlash, (Simon & Schuster, New York,

2000), p. 8; “Antidepressants Lift Clouds, But Lost ‘Miracle Drug’ Label,” The New York Times, 30 June 2002; Alice Park, “More

Drugs To Treat Hyperactivity,” TIME Magazine, 10 Sept. 2001; Wellbutrin/Bupropion, Prozac Truth website; “Teen Suffers Seizure

After Snorting Antidepressant,” HealthScoutNews Reporter, 23 Apr. 2003.

31 Dr. Candace B. Pert, Letter to the Editor, TIME Magazine, 20 Oct. 1997, p. 8.

32 “Worsening Depression and Suicidality in Patients Being Treated with Antidepressant Medication,” FDA Public Health Advisory, 22

Mar. 2004.

33 Gardiner Harris, “Antidepressant Study Seen to Back Expert,” The New York Times, 20 Aug. 2004.

34 “Antidepressant aggression concern,” BBC News Online, 21 Sept. 2004.

35 “Suicidality in Children and Adolescents Being Treated With Antidepressant Medications,” FDA Public Health Advisory, 15 Oct. 2004.

36 “New advice on prescribing anti-depressants,” New Zealand Ministry of Health Media Release, 21 Oct. 2004.

37 “Use of SSRI antidepressants in children and adolescents,” Australian Adverse Drug Reactions Bulletin, Vol. 23, No. 6, Dec. 2004.

38 “European Medicines Agency finalises review of antidepressants in children and adolescents,” European Medicines Agency Press

Release, 25 Apr. 2005.

39 Sarah Boseley, “Suicide fear from antidepressants,” The Guardian (London), 18 Feb. 2005.

40 Joanna Moncrieff and Irving Kirsch, “Efficacy of Antidepressants in Adults,” British Medical Journal, Vol. 331, 16 July 2005, pp.

155-157; Salynn Boyles, “Battle Brews Over Antidepressant Use,” Fox News, 15 Jul. 2005.

41 “Suicidality with SSRIs: adults and children,” Australian Adverse Drug Reactions Bulletin, Vol. 24, No. 4, Aug. 2005.

42 “Annex II,” Commission Decision of 19-VIII-2005, Commission of the European Communities, 19 Aug. 2005.

43 Ivar Aursnes, et al., “Suicide Attempts in Clinical Trials with Paroxetine Randomised Against Placebo,” BMC Medicine, Vol. 3, pp.

14-18.

44 Sheryl Ubelacker, “SSRI antidepressants may raise suicide risk in elderly patients: study,” Sympatico, 1 May 2006.

45 “Antidepressants should list new risks: FDA,” Reuters, 19 July 2006; “Combined Use of 5-Hydroxytryptamine Receptor Agonists (Triptans), Selective Serotonin Reuptake Inhibitors (SSRIs) or Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs) May

Result in Life-threatening Serotonin Syndrome,” FDA Public Health Advisory, 19 July 2006.

46 “FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressants,” FDA News, 2 May 2007.

47 “Antidepressants and suicidal thoughts and behaviour,” Pharmacovigilance Working Party, Jan. 2008.

48 Yan Chen, et al., “Risk of Cerebrovascular Events [CVE] Associated with Antidepressant Use in Patients with Depression: A

Population-Bases, Nested Case-Control Study,” The Annals of Pharmacotherapy, Vol. 42, No. 2, pp. 177-184, 22 Jan. 2008.

49 “Implementation of warnings on suicidal thoughts and behaviour in antidepressants,” MHRA, 5 February 2008.

50 Irving Kirsch, et al., “Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug

Administration,” Public Library of Science, Vol. 5, Iss. 2, 26 Feb. 2008.

51 “Antidepressant drug use and risk of venous thromboembolism,” Pharmacotherapy, Vol. 28, No. 2, 28 Feb. 2008.

52 Thomas Laughren, M.D., Letter to GlaxoSmithKline Attn: Randal L. Batenhorst, Food and Drug Administration, Jan. 2009.

53 Benedict Carey, “Treatment of Depression in Pregnancy Affects Babies,” The New York Times, 4 Feb. 2005.

54 “General information concerning use of SSRI antidepressants in pregnant women,” Therapeutic Goods Administration, 7 Sept. 2005.

55 “Paroxetine HCL – Paxil and generic paroxetine,” 2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary

Supplements, FDA MedWatch, 27 Sept. 2005.

56 Steve Mitchell, “Analysis: SSRIs’ risk to infants,” United Press International, 6 Feb. 2006.

57 “Advisory – Newer antidepressants linked to serious lung disorder in newborns,” Health Canada press release, 10 Mar. 2006.

58 Maria Bishop, “Use of Antidepressants in Pregnancy Affects Neonatal Outcomes: Presented at AACAP,” Doctor’s Guide, 29 Oct.

2007.

59 “Paxil, Prozac, Zoloft and Other SSRI Antidepressants Tied to Premature Birth,” News Inferno, 6 May 2008.

60 “Duloxetine hydrochloride (marketed as Cymbalta) information,” FDA information sheet, 30 June 2005.

61 “Cymbalta (duloxetine hydrochloride),” 2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements, FDA

MedWatch, 17 Oct. 2005.

62 “NDA # 21-733. CYMBALTA® (duloxetine hydrochloride) Delayed-release Capsules. MACMIS # 14550,” FDA, 2 Oct. 2007.

63 “Paroxetine,” FDA Public Health Advisory, 8 Dec. 2005.

64 Benedict Carey and Gardiner Harris, “Antidepressant May Raise Suicide Risk,” The New York Times, 12 May 2006.

65 Corrado Barbui, M.D., et al., “Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic reexamination

of published and unpublished data from randomized trials,” Canadian Medical Association Journal, Vol. 178, No. 3, 29

Jan. 2008.

66 “New Warning for Strattera,” FDA Talk Paper, 17 Dec. 2004.

67 “Attention Drug to Get New Warning,” Los Angeles Times, 18 Dec. 2004.

68 “Strattera to Get New Risk Label,” The Washington Post, 18 Dec. 2004.

69 “New Drugs in Pipeline,” Psychiatric News, 21 Dec. 2001.

70 “Lilly to add suicide warning to Strattera,” ABC News, 29 Sept. 2005.

71 “Atomoxetine and suicidal behavior: update,” Canadian Adverse Reaction Newsletter, Vol. 18, Iss. 3, July 2008.

72 “Atomoxetine: risk of psychotic or manic symptoms,” Drug Safety Update, MHRA, Vol. 2, Iss. 8, March 2009.

73 “Teen Suffers Seizure After Snorting Antidepressant,” HealthScoutNews Reporter, 23 Apr., 2003.

74 Op. cit., Prozac Truth website.

75 Alice Park, “More Drugs To Treat Hyperactivity,” TIME Magazine, 10 Sept. 2001.

76 Op. cit., Prozac Truth website.

77HealthScoutNews Reporter.

78 Op. cit. Physicians’ Desk Reference, http://www.pdrhealth.com.

79 “Suicidality in Children and Adolescents Being Treated With Antidepressant Medications,” FDA Public Health Advisory, 15 Oct.

2004.

80 Op cit.New Zealand Ministry of Health.

81 Italian Official Gazette, No. 224, 26 Sept. 2005.

82 “Depression in Children and Young People,” National Institute for Health and Clinical Excellence, Sept. 2005, pp. 16, 18 and 28.

83 FDA, “Antidepressant Use in Children, Adolescents, and Adults,” www.fda.gov/CDER/Drug/antidepressants?default.html, updated

2 May 2007.

84 Op. Cit.Maria Bishop.

85 “Antidepressant drug use and risk of venous thromboembolism,” Pharmacotherapy, Vol. 28, No. 2, 28 Feb. 2008.

86 Physicians’ Desk Reference, http://www.pdrhealth.com; “ABILIFY Rx Only (aripiprazole) Tablets,” Package Insert, revised Mar.

2004; “GENERIC NAME: Aripiprazole BRAND NAME: Abilify,” Internet URL: http://www.MedicineNet.com, Last Editorial

Review: 9/8/04; “Aripiprazole Brand Name: Abilify,” Internet URL: http://www.HealthyPlace.com, Ty C. Colbert, Rape of the Soul,

How the Chemical Imbalance Model of Modern Psychiatry has Failed its Patients, (Kevco Publishing, California, 2001), p. 106.

87 Robert Whitaker, Mad in America: Bad Science, Bad Medicine, and the Enduring Mistreatment of the Mentally Ill, (Perseus

Publishing, New York, 2002), pp. 182, 186.

88 Op. cit., Robert Whitaker, p. 208.

89 George Crane, “Tardive Dyskinesia in Patients Treated with Major Neuroleptics: A Review of the Literature,” American Journal of

Psychiatry, Vol. 124, Supplement, 1968, pp. 40-47.

90 Michael J. Burns, “The Pharmacology and Toxicology of Atypical Antipsychotic Agents,” Journal of Toxicology, 1 Jan. 2001.

91 Ibid.

92 “FDA: Antipsychotic Drugs, Diabetes Linked,” Associated Press Online, 18 Sept. 2003.

93 “Atypical antipsychotics and hyperglycaemia,” Australian Adverse Drug Reactions Bulletin, Vol. 23, No. 3, June 2004.

94 Jeffrey A. Lieberman, M.D., et al., “Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia,” The New England Journal of Medicine, Vol. 353, No. 12, 22 Sept. 2005.

95 Philip S. Wang, et al., “Risk of Death in Elderly Users of Conventional vs. Atypical Antipsychotic Medication,” The New England

Journal of Medicine, Vol. 353, No. 22, 1 Dec. 2005.

96 Marilyn Elias, “New antipsychotic drugs carry risks for children; Side effects can lead to bigger health problems,” USA Today, 2

May 2006.

97 Peter Tyrer, et al., “Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with

intellectual disability: a randomized controlled trial,” The Lancet, Vol. 371, 5 Jan. 2008.

98 Wilma Knol, M.D., et al., “Antipsychotic Drug Use and Risk of Pneumonia in Elderly People,” The American Geriatrics Society, Vol.

56, No. 4, pp. 661-666, Apr. 2008.80

99 Hugo Lovheim, M.D., Stig Karlsoon, R.N., Ph.D., et al., “The use of central nervous system drugs and analgesics among very old

people with and without dementia,” Pharmacoepidemiology and Drug Safety, 9 Apr. 2008.

100 Paula A. Rochon, M.D., MPH, FRCPC, et al., “Antipsychotic Therapy and Short-term Serious Events in Older Adults With

Dementia,” The Archives of Internal Medicine, Vol. 168, No. 10, 26 May 2008.

101 “Information for Healthcare Professionals Antipsychotics,” FDA, June 2008; “US FDA expands antipsychotic drug warning,”

Reuters UK, 17 June 2008.

102 “Update on the safety of antipsychotic medicines – risk of stroke and increased risk of mortality in elderly patients treated for

dementia,” Drug Safety Newsletter, Iss. 30, Apr. 2009, p. 5.

103 MedicineNet.com, Last Editorial Review: 9/8/04.

104 “Abilify Information,” Pharma-Help.com.

105 “The New Anti-Psychotic Drug Aripiprazole (ABILIFY),” Public Citizen’s eLetter, Apr. 2003.

106 Op. cit., “ABILIFY Rx Only (aripiprazole) Tablets,”

107 “Clozapine and Achy Breaky Hearts,” MedSafe, May 2008.

108 Watching Briefs, MedSafe, June 2008.

109 “Information for Healthcare Professionals Haloperidol (marketed as Haldol, Haldol Decanoate and Haldol Lactate),” FDA ALERT,

17 Sept. 2007.

110 Jeff Swiatek, “Uncertainty was Driver in Zyprexa Deal,” IndianapolisStar.com, 11 June 2005.

111 Op. cit., Jeffrey A. Lieberman, M.D., et al.

112 “Study: New drugs little better for schizophrenia,” St. Petersburg Times, 20 Sept. 2005.

113 “Important Safety Information about ZYPREXA® (olanzapine),” Eli Lilly and Company, 5 Oct. 2007; “Lilly Announces Updates

to the Zyprexa and Symbyax U.S. Labels,” PRNewswire, Bio-Medicine, 5 Oct. 2007.

114 ZYPREXA Safety Information, www.zyprexa.com.

115 Physicians’ Desk Reference, http://www.pdrhealth.com.

116 Tracey McVeigh, “Tranquilizers ‘more lethal than heroin,’” The Observer, 5 Nov. 2000.

117 Matt Clark, Mary Hager, “Valium Abuse: The Yellow Peril,” Newsweek, 24 Sept. 1979; Dr. Patrick Holford, “How to Quit

Tranquilizers,” www.patrickholdford.com, 2008.

118 Ibid.

119 Op. cit., Tracey McVeigh.

120 “Elderly On Long-Acting Anxiety, Insomnia Drugs Have More Car Crashes,” Doctor’s Guide citing Journal of American Medical

Association, 30 June 1997.

121 “Agression, Violence & Bezodiazapines,” Benzo.org.uk, citing British National Formulary, 2001.

122 Benzo.org.uk, citing Professor C. Heather Ashton, Benzodiazepines: How They Work and How To Withdraw, Feb. 2001.

123 “The Influence on the Pharmaceutical Industry,” House of Commons, UK, Health Committee, Vol. 1, Mar. 2005. p. 65.

124 Tarja-Brita R. Wahlin, et al., “Falls and fall risk among nursing home residents,” The Journal of Clinical Nursing, Vol. 17, pp. 126-

134, Jan. 2008.

125 “Europe-wide review recommends updates to product information for varenicline (brand name Champix),” MHRA, 14 Dec. 2008.

126 “Early Communication About an Ongoing Safety Review Varenicline (marketed as Chantix),” FDA, 20 Nov. 2007.

127 “Varenicline (marketed as Chantix) Information,” FDA Alert, 1 Feb. 2008.

128 Op. cit., House of Commons, UK, Health Committee, p. 65.

129 Anna Maria Dademan, “Flunitrazepam and violence—psychiatric and legal issues,” Department of Clinical Neuroscience,

Occupational Therapy and Elderly Care, Research Division of Forensic Psychiatry, Karolinska Institute, Sweden, 2000, p. 43.

130 “Zolpidem (‘Stilnox’) – Updated information – February 2008,” Theraputic Goods Administration, 21 Feb. 2008; “Club Drugs: An

Update,” Drug Intelligence Brief, Drug Enforcement Administration, Sept. 2001.

131 “FDA Safety Changes: Ambien, Primazin IM/IV, Hepsera,” Medscape, 28 Aug. 2008.

132 Peter Breggin, Toxic Psychiatry, (St. Martin’s Press, New York, 1991) p. 245.

133 Jerrold F. Rosenbaum, et al., “Emergence of Hostility During Alprazolam Treatment in Borderline Personality Disorder,” The

American Journal of Psychiatry, Vol. 141, No. 6 (June 1984), pp. 792-793.

134 David L. Gardner and Rex W. Cowdrey, “Alprazolam-Induced Dyscontrol in Borderline Personality Disorder,” The American

Journal of Psychiatry, Vol. 142, No. 1 (Jan. 1985), pp. 98-100.

135 “Xanax addiction extremely tough to kick,” MSNBC News Online, 2001.

136 Statement by Joseph A. Califano, Jr., Chairman and President, “Under the Counter: The Diversion and Abuse of Controlled

Prescription Drugs in the U.S.” The National Center on Addiction and Substance Abuse at Columbia University, July 2005.

137 Physicians’ Desk Reference, (Medical Economics Company, New Jersey, 1998), pp. 2822-2823; David L. Richman, M.D., Leonard

Roy Frank, and Art Mandler, Dr. Caligari’s Psychiatric Drugs (Alonzo Printing Co., Inc., California, 1984), p. 39.

138 Op. cit., David L. Richman, M.D., et al., pp. 38-39.

139 Ibid.

Source: http://www.cchrint.org/pdfs/The_Side_Effects_of_Common_Psychiatric_Drugs.pdf

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Suicide is a major complication of withdrawal from Ritalin and similar amphetamine-like drugs.2
Note: The U.S. Drug Enforcement Administration (DEA) classifies methylphenidate, the generic name for Ritalin, Concerta, Metadate and Methylin, as a Schedule II narcotic in the same abuse category as morphine, opium and cocaine.3
Methylphenidate is amphetamine-like because it is very similar in chemical structure to amphetamine and how it affects the body. The DEA says that it is structurally and pharmacologically similar to cocaine. An amphetamine’s chemical structure resembles natural stimulants in the body, like adrenaline. However, as a drug, it alters the natural system and can reduce appetite and fatigue and “speed” you up. A stimulant (psychostimulant) refers to any mind-altering chemical or substance that affects the central nervous system by speeding up the body’s functions, including the heart and breathing rates. Stimulants are
most often prescribed to children for the so-called condition Attention Deficit Hyperactivity Disorder (ADHD). In children, however, stimulants appear to act as suppressants, but psychiatrists and doctors have no idea why. A 1999 study published in Science Journal, determined: “The mechanism by which psychostimulants act as calming agents…is currently unknown.”4
NON-STIMULANT “ADHD” Drugs:
Celexa (citalopram), Strattera (atomoxetine) and Wellbutrin (buproprion HCL) are
all antidepressants prescribed to treat “ADHD” and are covered in the section on new
antidepressants (page 8). Strattera is the only one the FDA has approved for treating ADHD
and carries serious warnings (page 15).
GENERAL WARNINGS AND STUDIES ON PSYCHOSTIMULANTS:
June 28, 2005: The Food and Drug Administration (FDA) identified possible safety concerns
with methylphenidate (Ritalin, Adderall, Concerta, etc.) drug products. Specifically
noted were psychiatric adverse effects when prescribed to treat “ADHD,” such as visual
hallucinations, suicidal ideation, psychotic behavior, aggression and violent behavior.5
September 13, 2005: The Oregon Health & Science University, Evidence-Based Practice
Center published the findings of its review of 2,287 studies—virtually every study ever
conducted on ADHD drugs—and found that no trials had shown the effectiveness of these
drugs and that there was a lack of evidence that they could affect “academic performance,
risky behaviors, social achievements, etc.” Further, “We found no evidence on long-term
safety of drugs used to treat ADHD in young children” or “adolescents.”6
January 5, 2006: The FDA said it had received reports of sudden deaths, strokes, heart
attacks and hypertension (high blood pressure) in both children and adults taking ADHD
drugs and asked its Drug Safety and Risk Management advisory committee to examine the
potential of cardiovascular (heart) risks of the drugs.7
February 4, 2006: A University of Texas study published in Pediatric Neurology reported
cardiovascular problems in children taking stimulants.8
February 9, 2006: The FDA’s Drug Safety and Risk Management Advisory Committee
urged that the FDA’s strongest “black box” warning be issued for stimulants because they
may cause heart attacks, strokes and sudden death.9
March 22-23, 2006: Two FDA advisory panels held hearings into the risk of stimulants and
another new ADHD drug called Sparlon (Provigil). Between January 2000 and June 30,
2005, the FDA had received almost 1,000 reports of kids experiencing psychosis or mania
while taking the drugs. The first panel recommended stronger warnings against stimulants,
emphasizing these should appear on special handouts called “Med Guides” (Medication
Guides) that doctors must give to patients with each prescription. The second committee
recommended against approval of Sparlon.10
March 28, 2006: The Australian Therapeutic Goods Administration reported 400 adverse
reactions to stimulants in children taking them, including strokes, heart attacks and
hallucinations.11
December 2007: A study in the journal Pediatrics concluded: “[S]timulants were associated
with an increase in cardiac emergency department visits.”12
February 2008: A study in Arthritis & Rheumatism, entitled, “Association between
treatment with central nervous system [CNS] stimulants and Raynaud’s Syndrome [RS*]
in children: a retrospective case-control study of rheumatology [disorder of the muscles,
tendons, joints, bones, or nerves, characterized by discomfort and disability] patients,”
concluded: “[T]here is a significant association between development of RS and therapy
with CNS stimulants used for the treatment of ADHD.”13 [*RS: Discoloration of the fingers
and/or toes after changes in temperature or emotional events due to abnormal spasms of the
blood vessels resulting in lost blood supply to the area.]
Abuse of Stimulants:
The FDA requires stimulants such as Ritalin and Adderall to carry a boxed warning that
states the drug is “a federally controlled substance because it can be abused or lead to
dependence. Keep RITALIN [Adderall] in a safe place to prevent misuse and abuse.”
August 2001: A study published in the Journal of the American Medical Association
concluded that methylphenidate is chemically similar to cocaine.14 Children who took
stimulants were more likely to start smoking or use cocaine and continue these habits into
adulthood.15
April 2005: Partnership for a Drug-Free America released the findings of its survey, which
determined that 10% (2.3 million) of teens had abused Ritalin and Adderall.16
February 25, 2006: A study in the journal Drug and Alcohol Dependence revealed that
seven million Americans were estimated to have abused stimulant drugs and a substantial
amount of teenagers and young adults appeared to show signs of addiction.17
WARNINGS AND STUDIES ON SPECIFIC PSYCHOSTIMULANTS:
ADDERALL (amphetamine and dextroamphetamine):
Adderall is an amphetamine mixture that has been linked to violent behavior when, in
1999, a North Dakota judge acquitted 24-year-old Ray Ehlis of murdering his 5-week-old
daughter after two independent psychiatrists testified he was suffering a severe psychosis
induced by Adderall.18
June 2004: The FDA ordered that the packaging for Adderall include a warning about
sudden cardiovascular deaths, especially in children with underlying heart disease.19
February 9, 2005: Health Canada, the Canadian counterpart of the FDA, suspended
marketing of Adderall XR (Extended Release, given once a day) due to reports of 20
sudden unexplained deaths (14 in children) and 12 strokes (2 in children) in patients taking
Adderall or Adderall XR. However, in August 2005, Health Canada agreed to reinstate the
marketing authorization with a number of revisions to the labeling to warn against the use
of Adderall XR in patients with structural heart abnormalities and advised about the dangers
of misusing amphetamines.20 The FDA warned that as Adderall is an amphetamine, it has a
“high potential for abuse. Taking amphetamines for long periods of time may lead to drug
addiction.” Further, Adderall should never be taken in conjunction with antidepressants in
the (MAOI) Monoamine Oxidase Inhibitor class.21 (See page 17)
CYLERT (pemoline):
September 1997: Britain removed Cylert from the market after reports of death related
to liver toxicity in people taking it. Cylert posed a threat of serious liver complications,
including liver failure resulting in death or liver transplantation.22
September 1999: Canada removed Cylert from the market after reports of death related to
liver toxicity in people taking it.23
October 24, 2005: The FDA finally withdrew Cylert from the market because of its
“overall risk of liver toxicity” and liver failure.24
METADATE CD (methylphenidate):
Metadate is a reformulation of Ritalin for extended delivery over several hours and carries
the same warnings as Ritalin and potential for abuse. Metadate should not be taken if:
“You have significant anxiety, tension, or agitation since METADATE CD may make
these conditions worse…you have glaucoma, an eye disease, you have tics or Tourette’s
Syndrome (condition manifesting in involuntary physical and vocal tics.)”11
Provigil (modafinil):
Provigil was approved to treat daytime sedation as a means to keep people awake. Its
manufacturer, Cephalon, unsuccessfully attempted to get FDA approval for the drug’s use
in treatment of ADHD under the trade name Sparlon. However, this does not mean that
psychiatrists or physicians will not prescribe Provigil for ADHD, even though it is not FDA
approved for this use or for any pediatric use.
September 2007: Cephalon sent a letter to health care professionals informing them of new
warnings: “1. Provigil can cause life-threatening skin and other serious hypersensitivity
reactions…. 2. Provigil is not approved for use in pediatric patients for any indication. 3.
Provigil can cause psychiatric symptoms.”25
RITALIN (methylphenidate):
The Physicians’ Desk Reference (PDR) warns, “psychotic episodes can occur” with abuse.
Suicide is the major complication of withdrawal from Ritalin and similar drugs.26
The DEA says Ritalin could lead to addiction and that “psychotic episodes, violent behavior
and bizarre mannerisms have been reported” with its use.27
October 17, 2007: In Japan, the Health, Labor and Welfare Ministry panel (similar to
the FDA) removed Ritalin from its list of approved medicines to treat depression. It was
considered that it could exacerbate the already significant amount of Ritalin abuse in the
country.28
2008: The current FDA Medication Guide warns of heart-related problems with Ritalin and
other stimulants, including, “sudden death in patients who have heart problems or heart
defects; stroke and heart attack in adults; increased blood pressure and heart rate.” Further,
for all patients, “new or worse behavior and thought problems…new or worse aggressive
behavior or hostility” and in children and teens, “new psychotic symptoms (such as hearing
voices, believing things that are not true, are suspicious) or new manic symptoms.”29
*Tourettes’s Syndrome: a neurological disorder characterized by recurrent involuntary movements,
including multiple neck jerks and sometimes vocal tics, as grunts, barks, or words, esp. obscenities.
References
1 Physicians’ Desk Reference, http://www.pdrhealth.com; “Adderall,” DrugStore.com, Internet URL: http://www.drugstore.com;
“Study Suggests Focalin (TM) LA Capsules (d-MPH-ER) Are Safe and Effective for ADHD in Adults,” PR Newswire, 5 May 2004;
A.D.D. Warehouse website; ADHDHelp, Internet URL: http://www.adhdhelp.org/metadate.htm. Journal of the Royal Society of Med.,
Vol 92, Mar. 99 “letters to the editor” p. 156. Medline Plus, www.nim.nih.gov/medlineplus: Millichap, J.Gordon “Methylphenidate
Role in Tourettes Syndrome Prevalence.
2 Diagnostic and Statistical Manual of Mental Disorders (DSM-III-R), American Psychiatric Association, Washington, D.C., 1987, p. 136.
3 “Drug Scheduling,” U.S. Drug Enforcement Administration Online, Internet URL: http://www.dea.gov.
4 Raul R. Gainetdinov; William C. Wetsel; Edward D. Sara; R. Levin Jones; Mohamed Jaber; Marc G. Caron, “Role of Serotonin in the
Paradoxical Calming Effect of Psychostimulants on Hyperactivity,” Science, 15 Jan. 1999.
5 “Statement on Concerta and Methylphenidate,” Statement posted on the FDA website, 28 June 2005.
6 Marian S. MacDonagh, PharmaD, and Kim Peterson, MS, “Drug Class Review on Pharmacologic Treatment for ADHD: Final
Report,” Oregon Health and Science University, Sept. 2005, pp. 13-20.
7 “FDA will study safety of attention-deficit drugs,” Kansas City Star, 5 Jan. 2006.
8 “Stimulants in children with ADHD may have negative CV effect,” Mental Health Law Weekly, 4 Feb. 2006.
9 Ricardo Alonso-Zaldivar, “Warning Urged for ADHD Drugs,” Los Angeles Times, 10 Feb. 2006.
10 Todd Zwillich, “FDA Panel Recommends Warnings of Rare Reports of Aggressive Behavior or Psychotic Symptoms,” WebMD, 23
Mar. 2006.
11 “Dark side of a wonder drug,” The Australian, 28 Mar. 2006.
12 Almut G. Winterstein, et al., “Cardiac Safety of Central Nervous System Stimulants in Children and Adolescents With Attention-
Deficit/Hyperactivity Disorder,” Pediatrics, Vol. 120, Dec. 2007, pp. e1494-e1501.
13 W. Goldman, et al., “Association between treatment with central nervous system stimulants and Raynaud’s Syndrome in children: a
study of rheumatology patients,” Arthritis & Rheumatism, Vol. 58, No. l, 2 Feb. 2008, pp. 563-566.
14 Brian Vastig, “Pay Attention: Ritalin Acts Much Like Cocaine,” JAMA, 22/29 Aug. 2001, Vol. 286, No. 8, p. 905.
15 Joel Turtel, Public Schools, Public Menace: How Public Schools Lie to Parents and Betray Our Children, (Library Books, New
York), 2004-2005, p. 135.
16 “Partnership Attitude Tracking Study” of teens in 2004, 17th Annual report by Partnership for a Drug-Free America, 21 Apr. 2005;
“Survey: 1 in 5 teens getting high on medications, over-counter drugs,” NewsItem.com, 2 May 2005.
17 Larry A. Kroutil, et al., “Nonmedical use of prescription stimulants in the United States,” Drug and Alcohol Dependence, Feb. 2006.
18 Brian Witte, “Slaying blamed on reaction to hyperactivity drug,” Associated Press, 25 Oct. 1999.
19 “J & J Psychiatric Safety Labeling, Cardiovascular Events Are Topic For Cmte,” FDAAdvisoryCommittee.com, June 2005.
20 “Health Canada Suspends Marketing of Adderall,” FDA Alert, 9 Feb. 2005.
21 “Health Canada allows Adderall XR® back on the Canadian market,” Health Canada News Release, 24 Aug. 2005.
22 Partnership Attitude Tracking Study, Teens – 2004, Partnership for a Drug-Free America, 21 Apr. 2005, p. 7; “Cylert recall
demanded over safety concerns,” Lifestyle News, www.mynippon.com/news/2005/03/cylert-recall-demanded-over-safety-concerns.
23 “Injured by Cylert?” Parker Waichman Alonso, LLP, http://www.yourlawyer.com/topics/overview/cylert.
24 “FDA Withdraws Approval for ADD Drug,” Associated Press, 24 Oct. 2005.
25 “Updated Safety Information: Warnings regarding serious rash, including Stevens-Johnson Syndrome and hypersensitivity reactions,
and psychiatric symptoms,” Cephalon, Inc., Sept. 2007.
26 Op. cit., DSM-III-R, pp. 136, 175.; Medical Economics Company, Physicians Desk Reference (Montvale, NJ: Medical Economics
Co, 1998), pp. 1,897.
27 “Methylphenidate (A Background Paper),” U.S. Drug Enforcement Administration, Oct. 1995, p. 16.
28 “Antidepressant Ritalin to be delisted because of abuse,” Daily Yomiuri Online, 19 Oct. 2007.
29 Ritalin Drug Label, fda.gov.
30 Physicians’ Desk Reference, http://www.pdrhealth.com; Joseph Glenmullen, M.D. Prozac Backlash, (Simon & Schuster, New York,
2000), p. 8; “Antidepressants Lift Clouds, But Lost ‘Miracle Drug’ Label,” The New York Times, 30 June 2002; Alice Park, “More
Drugs To Treat Hyperactivity,” TIME Magazine, 10 Sept. 2001; Wellbutrin/Bupropion, Prozac Truth website; “Teen Suffers Seizure
After Snorting Antidepressant,” HealthScoutNews Reporter, 23 Apr. 2003.
31 Dr. Candace B. Pert, Letter to the Editor, TIME Magazine, 20 Oct. 1997, p. 8.
32 “Worsening Depression and Suicidality in Patients Being Treated with Antidepressant Medication,” FDA Public Health Advisory, 22
Mar. 2004.
33 Gardiner Harris, “Antidepressant Study Seen to Back Expert,” The New York Times, 20 Aug. 2004.
34 “Antidepressant aggression concern,” BBC News Online, 21 Sept. 2004.
35 “Suicidality in Children and Adolescents Being Treated With Antidepressant Medications,” FDA Public Health Advisory, 15 Oct. 2004.
36 “New advice on prescribing anti-depressants,” New Zealand Ministry of Health Media Release, 21 Oct. 2004.
37 “Use of SSRI antidepressants in children and adolescents,” Australian Adverse Drug Reactions Bulletin, Vol. 23, No. 6, Dec. 2004.
38 “European Medicines Agency finalises review of antidepressants in children and adolescents,” European Medicines Agency Press
Release, 25 Apr. 2005.
39 Sarah Boseley, “Suicide fear from antidepressants,” The Guardian (London), 18 Feb. 2005.
40 Joanna Moncrieff and Irving Kirsch, “Efficacy of Antidepressants in Adults,” British Medical Journal, Vol. 331, 16 July 2005, pp.
155-157; Salynn Boyles, “Battle Brews Over Antidepressant Use,” Fox News, 15 Jul. 2005.
41 “Suicidality with SSRIs: adults and children,” Australian Adverse Drug Reactions Bulletin, Vol. 24, No. 4, Aug. 2005.
42 “Annex II,” Commission Decision of 19-VIII-2005, Commission of the European Communities, 19 Aug. 2005.
43 Ivar Aursnes, et al., “Suicide Attempts in Clinical Trials with Paroxetine Randomised Against Placebo,” BMC Medicine, Vol. 3, pp.
14-18.
44 Sheryl Ubelacker, “SSRI antidepressants may raise suicide risk in elderly patients: study,” Sympatico, 1 May 2006.
45 “Antidepressants should list new risks: FDA,” Reuters, 19 July 2006; “Combined Use of 5-Hydroxytryptamine Receptor Agonists (Triptans), Selective Serotonin Reuptake Inhibitors (SSRIs) or Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs) May
Result in Life-threatening Serotonin Syndrome,” FDA Public Health Advisory, 19 July 2006.
46 “FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressants,” FDA News, 2 May 2007.
47 “Antidepressants and suicidal thoughts and behaviour,” Pharmacovigilance Working Party, Jan. 2008.
48 Yan Chen, et al., “Risk of Cerebrovascular Events [CVE] Associated with Antidepressant Use in Patients with Depression: A
Population-Bases, Nested Case-Control Study,” The Annals of Pharmacotherapy, Vol. 42, No. 2, pp. 177-184, 22 Jan. 2008.
49 “Implementation of warnings on suicidal thoughts and behaviour in antidepressants,” MHRA, 5 February 2008.
50 Irving Kirsch, et al., “Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug
Administration,” Public Library of Science, Vol. 5, Iss. 2, 26 Feb. 2008.
51 “Antidepressant drug use and risk of venous thromboembolism,” Pharmacotherapy, Vol. 28, No. 2, 28 Feb. 2008.
52 Thomas Laughren, M.D., Letter to GlaxoSmithKline Attn: Randal L. Batenhorst, Food and Drug Administration, Jan. 2009.
53 Benedict Carey, “Treatment of Depression in Pregnancy Affects Babies,” The New York Times, 4 Feb. 2005.
54 “General information concerning use of SSRI antidepressants in pregnant women,” Therapeutic Goods Administration, 7 Sept. 2005.
55 “Paroxetine HCL – Paxil and generic paroxetine,” 2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary
Supplements, FDA MedWatch, 27 Sept. 2005.
56 Steve Mitchell, “Analysis: SSRIs’ risk to infants,” United Press International, 6 Feb. 2006.
57 “Advisory – Newer antidepressants linked to serious lung disorder in newborns,” Health Canada press release, 10 Mar. 2006.
58 Maria Bishop, “Use of Antidepressants in Pregnancy Affects Neonatal Outcomes: Presented at AACAP,” Doctor’s Guide, 29 Oct.
2007.
59 “Paxil, Prozac, Zoloft and Other SSRI Antidepressants Tied to Premature Birth,” News Inferno, 6 May 2008.
60 “Duloxetine hydrochloride (marketed as Cymbalta) information,” FDA information sheet, 30 June 2005.
61 “Cymbalta (duloxetine hydrochloride),” 2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements, FDA
MedWatch, 17 Oct. 2005.
62 “NDA # 21-733. CYMBALTA® (duloxetine hydrochloride) Delayed-release Capsules. MACMIS # 14550,” FDA, 2 Oct. 2007.
63 “Paroxetine,” FDA Public Health Advisory, 8 Dec. 2005.
64 Benedict Carey and Gardiner Harris, “Antidepressant May Raise Suicide Risk,” The New York Times, 12 May 2006.
65 Corrado Barbui, M.D., et al., “Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic reexamination
of published and unpublished data from randomized trials,” Canadian Medical Association Journal, Vol. 178, No. 3, 29
Jan. 2008.
66 “New Warning for Strattera,” FDA Talk Paper, 17 Dec. 2004.
67 “Attention Drug to Get New Warning,” Los Angeles Times, 18 Dec. 2004.
68 “Strattera to Get New Risk Label,” The Washington Post, 18 Dec. 2004.
69 “New Drugs in Pipeline,” Psychiatric News, 21 Dec. 2001.
70 “Lilly to add suicide warning to Strattera,” ABC News, 29 Sept. 2005.
71 “Atomoxetine and suicidal behavior: update,” Canadian Adverse Reaction Newsletter, Vol. 18, Iss. 3, July 2008.
72 “Atomoxetine: risk of psychotic or manic symptoms,” Drug Safety Update, MHRA, Vol. 2, Iss. 8, March 2009.
73 “Teen Suffers Seizure After Snorting Antidepressant,” HealthScoutNews Reporter, 23 Apr., 2003.
74 Op. cit., Prozac Truth website.
75 Alice Park, “More Drugs To Treat Hyperactivity,” TIME Magazine, 10 Sept. 2001.
76 Op. cit., Prozac Truth website.
77HealthScoutNews Reporter.
78 Op. cit. Physicians’ Desk Reference, http://www.pdrhealth.com.
79 “Suicidality in Children and Adolescents Being Treated With Antidepressant Medications,” FDA Public Health Advisory, 15 Oct.
2004.
80 Op cit.New Zealand Ministry of Health.
81 Italian Official Gazette, No. 224, 26 Sept. 2005.
82 “Depression in Children and Young People,” National Institute for Health and Clinical Excellence, Sept. 2005, pp. 16, 18 and 28.
83 FDA, “Antidepressant Use in Children, Adolescents, and Adults,” www.fda.gov/CDER/Drug/antidepressants?default.html, updated
2 May 2007.
84 Op. Cit.Maria Bishop.
85 “Antidepressant drug use and risk of venous thromboembolism,” Pharmacotherapy, Vol. 28, No. 2, 28 Feb. 2008.
86 Physicians’ Desk Reference, http://www.pdrhealth.com; “ABILIFY Rx Only (aripiprazole) Tablets,” Package Insert, revised Mar.
2004; “GENERIC NAME: Aripiprazole BRAND NAME: Abilify,” Internet URL: http://www.MedicineNet.com, Last Editorial
Review: 9/8/04; “Aripiprazole Brand Name: Abilify,” Internet URL: http://www.HealthyPlace.com, Ty C. Colbert, Rape of the Soul,
How the Chemical Imbalance Model of Modern Psychiatry has Failed its Patients, (Kevco Publishing, California, 2001), p. 106.
87 Robert Whitaker, Mad in America: Bad Science, Bad Medicine, and the Enduring Mistreatment of the Mentally Ill, (Perseus
Publishing, New York, 2002), pp. 182, 186.
88 Op. cit., Robert Whitaker, p. 208.
89 George Crane, “Tardive Dyskinesia in Patients Treated with Major Neuroleptics: A Review of the Literature,” American Journal of
Psychiatry, Vol. 124, Supplement, 1968, pp. 40-47.
90 Michael J. Burns, “The Pharmacology and Toxicology of Atypical Antipsychotic Agents,” Journal of Toxicology, 1 Jan. 2001.
91 Ibid.
92 “FDA: Antipsychotic Drugs, Diabetes Linked,” Associated Press Online, 18 Sept. 2003.
93 “Atypical antipsychotics and hyperglycaemia,” Australian Adverse Drug Reactions Bulletin, Vol. 23, No. 3, June 2004.
94 Jeffrey A. Lieberman, M.D., et al., “Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia,” The New England Journal of Medicine, Vol. 353, No. 12, 22 Sept. 2005.
95 Philip S. Wang, et al., “Risk of Death in Elderly Users of Conventional vs. Atypical Antipsychotic Medication,” The New England
Journal of Medicine, Vol. 353, No. 22, 1 Dec. 2005.
96 Marilyn Elias, “New antipsychotic drugs carry risks for children; Side effects can lead to bigger health problems,” USA Today, 2
May 2006.
97 Peter Tyrer, et al., “Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with
intellectual disability: a randomized controlled trial,” The Lancet, Vol. 371, 5 Jan. 2008.
98 Wilma Knol, M.D., et al., “Antipsychotic Drug Use and Risk of Pneumonia in Elderly People,” The American Geriatrics Society, Vol.
56, No. 4, pp. 661-666, Apr. 2008.80
99 Hugo Lovheim, M.D., Stig Karlsoon, R.N., Ph.D., et al., “The use of central nervous system drugs and analgesics among very old
people with and without dementia,” Pharmacoepidemiology and Drug Safety, 9 Apr. 2008.
100 Paula A. Rochon, M.D., MPH, FRCPC, et al., “Antipsychotic Therapy and Short-term Serious Events in Older Adults With
Dementia,” The Archives of Internal Medicine, Vol. 168, No. 10, 26 May 2008.
101 “Information for Healthcare Professionals Antipsychotics,” FDA, June 2008; “US FDA expands antipsychotic drug warning,”
Reuters UK, 17 June 2008.
102 “Update on the safety of antipsychotic medicines – risk of stroke and increased risk of mortality in elderly patients treated for
dementia,” Drug Safety Newsletter, Iss. 30, Apr. 2009, p. 5.
103 MedicineNet.com, Last Editorial Review: 9/8/04.
104 “Abilify Information,” Pharma-Help.com.
105 “The New Anti-Psychotic Drug Aripiprazole (ABILIFY),” Public Citizen’s eLetter, Apr. 2003.
106 Op. cit., “ABILIFY Rx Only (aripiprazole) Tablets,”
107 “Clozapine and Achy Breaky Hearts,” MedSafe, May 2008.
108 Watching Briefs, MedSafe, June 2008.
109 “Information for Healthcare Professionals Haloperidol (marketed as Haldol, Haldol Decanoate and Haldol Lactate),” FDA ALERT,
17 Sept. 2007.
110 Jeff Swiatek, “Uncertainty was Driver in Zyprexa Deal,” IndianapolisStar.com, 11 June 2005.
111 Op. cit., Jeffrey A. Lieberman, M.D., et al.
112 “Study: New drugs little better for schizophrenia,” St. Petersburg Times, 20 Sept. 2005.
113 “Important Safety Information about ZYPREXA® (olanzapine),” Eli Lilly and Company, 5 Oct. 2007; “Lilly Announces Updates
to the Zyprexa and Symbyax U.S. Labels,” PRNewswire, Bio-Medicine, 5 Oct. 2007.
114 ZYPREXA Safety Information, www.zyprexa.com.
115 Physicians’ Desk Reference, http://www.pdrhealth.com.
116 Tracey McVeigh, “Tranquilizers ‘more lethal than heroin,’” The Observer, 5 Nov. 2000.
117 Matt Clark, Mary Hager, “Valium Abuse: The Yellow Peril,” Newsweek, 24 Sept. 1979; Dr. Patrick Holford, “How to Quit
Tranquilizers,” www.patrickholdford.com, 2008.
118 Ibid.
119 Op. cit., Tracey McVeigh.
120 “Elderly On Long-Acting Anxiety, Insomnia Drugs Have More Car Crashes,” Doctor’s Guide citing Journal of American Medical
Association, 30 June 1997.
121 “Agression, Violence & Bezodiazapines,” Benzo.org.uk, citing British National Formulary, 2001.
122 Benzo.org.uk, citing Professor C. Heather Ashton, Benzodiazepines: How They Work and How To Withdraw, Feb. 2001.
123 “The Influence on the Pharmaceutical Industry,” House of Commons, UK, Health Committee, Vol. 1, Mar. 2005. p. 65.
124 Tarja-Brita R. Wahlin, et al., “Falls and fall risk among nursing home residents,” The Journal of Clinical Nursing, Vol. 17, pp. 126-
134, Jan. 2008.
125 “Europe-wide review recommends updates to product information for varenicline (brand name Champix),” MHRA, 14 Dec. 2008.
126 “Early Communication About an Ongoing Safety Review Varenicline (marketed as Chantix),” FDA, 20 Nov. 2007.
127 “Varenicline (marketed as Chantix) Information,” FDA Alert, 1 Feb. 2008.
128 Op. cit., House of Commons, UK, Health Committee, p. 65.
129 Anna Maria Dademan, “Flunitrazepam and violence—psychiatric and legal issues,” Department of Clinical Neuroscience,
Occupational Therapy and Elderly Care, Research Division of Forensic Psychiatry, Karolinska Institute, Sweden, 2000, p. 43.
130 “Zolpidem (‘Stilnox’) – Updated information – February 2008,” Theraputic Goods Administration, 21 Feb. 2008; “Club Drugs: An
Update,” Drug Intelligence Brief, Drug Enforcement Administration, Sept. 2001.
131 “FDA Safety Changes: Ambien, Primazin IM/IV, Hepsera,” Medscape, 28 Aug. 2008.
132 Peter Breggin, Toxic Psychiatry, (St. Martin’s Press, New York, 1991) p. 245.
133 Jerrold F. Rosenbaum, et al., “Emergence of Hostility During Alprazolam Treatment in Borderline Personality Disorder,” The
American Journal of Psychiatry, Vol. 141, No. 6 (June 1984), pp. 792-793.
134 David L. Gardner and Rex W. Cowdrey, “Alprazolam-Induced Dyscontrol in Borderline Personality Disorder,” The American
Journal of Psychiatry, Vol. 142, No. 1 (Jan. 1985), pp. 98-100.
135 “Xanax addiction extremely tough to kick,” MSNBC News Online, 2001.
136 Statement by Joseph A. Califano, Jr., Chairman and President, “Under the Counter: The Diversion and Abuse of Controlled
Prescription Drugs in the U.S.” The National Center on Addiction and Substance Abuse at Columbia University, July 2005.
137 Physicians’ Desk Reference, (Medical Economics Company, New Jersey, 1998), pp. 2822-2823; David L. Richman, M.D., Leonard
Roy Frank, and Art Mandler, Dr. Caligari’s Psychiatric Drugs (Alonzo Printing Co., Inc., California, 1984), p. 39.
138 Op. cit., David L. Richman, M.D., et al., pp. 38-39.
139 Ibid.

Source: http://www.cchrint.org/pdfs/The_Side_Effects_of_Common_Psychiatric_Drugs.pdf

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The most popular types of antidepressants are called selective serotonin reuptake inhibitors (SSRIs). These include:
Fluoxetine (Prozac)
Citalopram (Celexa)
Sertraline (Zoloft)
Paroxetine (Paxil)
Escitalopram (Lexapro).

Other types of antidepressants are serotonin and norepinephrine reuptake inhibitors (SNRIs). SNRIs are similar to SSRIs and include venlafaxine (Effexor) and duloxetine (Cymbalta). Another antidepressant that is commonly used is bupropion (Wellbutrin). Bupropion, which works on the neurotransmitter dopamine, is unique in that it does not fit into any specific drug type.

SSRIs and SNRIs are popular because they do not cause as many side effects as older classes of antidepressants. Older antidepressant medications include tricyclics, tetracyclics, and monoamine oxidase inhibitors (MAOIs). For some people, tricyclics, tetracyclics, or MAOIs may be the best medications.
What are the side effects?

Antidepressants may cause mild side effects that usually do not last long. Any unusual reactions or side effects should be reported to a doctor immediately.
The most common side effects associated with SSRIs and SNRIs include:
Headache, which usually goes away within a few days.
Nausea (feeling sick to your stomach), which usually goes away within a few days.
Sleeplessness or drowsiness, which may happen during the first few weeks but then goes away. Sometimes the medication dose needs to be reduced or the time of day it is taken needs to be adjusted to help lessen these side effects.
Agitation (feeling jittery).
Sexual problems, which can affect both men and women and may include reduced sex drive, and problems having and enjoying sex.
Tricyclic antidepressants can cause side effects, including:
Dry mouth.
Constipation.
Bladder problems. It may be hard to empty the bladder, or the urine stream may not be as strong as usual. Older men with enlarged prostate conditions may be more affected.
Sexual problems, which can affect both men and women and may include reduced sex drive, and problems having and enjoying sex.
Blurred vision, which usually goes away quickly.
Drowsiness. Usually, antidepressants that make you drowsy are taken at bedtime.

People taking MAOIs need to be careful about the foods they eat and the medicines they take. Foods and medicines that contain high levels of a chemical called tyramine are dangerous for people taking MAOIs. Tyramine is found in some cheeses, wines, and pickles. The chemical is also in some medications, including decongestants and over-the-counter cold medicine.

Mixing MAOIs and tyramine can cause a sharp increase in blood pressure, which can lead to stroke. People taking MAOIs should ask their doctors for a complete list of foods, medicines, and other substances to avoid. An MAOI skin patch has recently been developed and may help reduce some of these risks. A doctor can help a person figure out if a patch or a pill will work for him or her.

How should antidepressants be taken?

People taking antidepressants need to follow their doctors’ directions. The medication should be taken in the right dose for the right amount of time. It can take three or four weeks until the medicine takes effect. Some people take the medications for a short time, and some people take them for much longer periods. People with long-term or severe depression may need to take medication for a long time.

Once a person is taking antidepressants, it is important not to stop taking them without the help of a doctor. Sometimes people taking antidepressants feel better and stop taking the medication too soon, and the depression may return. When it is time to stop the medication, the doctor will help the person slowly and safely decrease the dose. It’s important to give the body time to adjust to the change. People don’t get addicted, or “hooked,” on the medications, but stopping them abruptly can cause withdrawal symptoms.

If a medication does not work, it is helpful to be open to trying another one. A study funded by NIMH found that if a person with difficult-to-treat depression did not get better with a first medication, chances of getting better increased when the person tried a new one or added a second medication to his or her treatment. The study was called STAR*D (Sequenced Treatment Alternatives to Relieve Depression).2,3

Are herbal medicines used to treat depression?

The herbal medicine St. John’s wort has been used for centuries in many folk and herbal remedies. Today in Europe, it is used widely to treat mild-to-moderate depression. In the United States, it is one of the top-selling botanical products.

The National Institutes of Health conducted a clinical trial to determine the effectiveness of treating adults who have major depression with St. Johns wort. The study included 340 people diagnosed with major depression. One-third of the people took the herbal medicine, one-third took an SSRI, and one-third took a placebo, or “sugar pill.” The people did not know what they were taking. The study found that St. John’s wort was no more effective than the placebo in treating major depression.4 A study currently in progress is looking at the effectiveness of St. John’s wort for treating mild or minor depression.

Other research has shown that St. John’s wort can dangerously interact with other medications, including those used to control HIV. On February 10, 2000, the FDA issued a Public Health Advisory letter stating that the herb appears to interfere with certain medications used to treat heart disease, depression, seizures, certain cancers, and organ transplant rejection. Also, St. Johns wort may interfere with oral contraceptives.

Because St. John’s wort may not mix well with other medications, people should always talk with their doctors before taking it or any herbal supplement.

FDA warning on antidepressants

Antidepressants are safe and popular, but some studies have suggested that they may have unintentional effects, especially in young people. In 2004, the FDA looked at published and unpublished data on trials of antidepressants that involved nearly 4,400 children and adolescents. They found that 4 percent of those taking antidepressants thought about or tried suicide (although no suicides occurred), compared to 2 percent of those receiving placebos (sugar pill).

In 2005, the FDA decided to adopt a “black box” warning label—the most serious type of warning—on all antidepressant medications. The warning says there is an increased risk of suicidal thinking or attempts in children and adolescents taking antidepressants. In 2007, the FDA proposed that makers of all antidepressant medications extend the warning to include young adults up through age 24.

The warning also says that patients of all ages taking antidepressants should be watched closely, especially during the first few weeks of treatment. Possible side effects to look for are depression that gets worse, suicidal thinking or behavior, or any unusual changes in behavior such as trouble sleeping, agitation, or withdrawal from normal social situations. Families and caregivers should report any changes to the doctor. To find the latest information visit the FDA website.

Results of a comprehensive review of pediatric trials conducted between 1988 and 2006 suggested that the benefits of antidepressant medications likely outweigh their risks to children and adolescents with major depression and anxiety disorders.5 The study was funded in part by NIMH.

Finally, the FDA has warned that combining the newer SSRI or SNRI antidepressants with one of the commonly-used “triptan” medications used to treat migraine headaches could cause a life-threatening illness called “serotonin syndrome.” A person with serotonin syndrome may be agitated, have hallucinations (see or hear things that are not real), have a high temperature, or have unusual blood pressure changes. Serotonin syndrome is usually associated with the older antidepressants called MAOIs, but it can happen with the newer antidepressants as well, if they are mixed with the wrong medications.
Source: http://www.nimh.nih.gov

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This booklet does not provide information about diagnosing mental disorders. Choosing the right medication, medication dose, and treatment plan should be based on a person’s individual needs and medical situation, and under a doctor’s care.

Information about medications is frequently updated. Check the FDA Web site for the latest information on warnings, patient medication guides, or newly approved medications. Throughout this document you will see two names for medications—the generic name and in parenthesis, the trade name. An example is fluoxetine (Prozac). See the end of this document for a complete alphabetical listing of medications.

What are psychiatric medications?

Psychiatric medications treat mental disorders. Sometimes called psychotropic or psychotherapeutic medications, they have changed the lives of people with mental disorders for the better. Many people with mental disorders live fulfilling lives with the help of these medications. Without them, people with mental disorders might suffer serious and disabling symptoms.

How are medications used to treat mental disorders?

Medications treat the symptoms of mental disorders. They cannot cure the disorder, but they make people feel better so they can function.

Medications work differently for different people. Some people get great results from medications and only need them for a short time. For example, a person with depression may feel much better after taking a medication for a few months, and may never need it again. People with disorders like schizophrenia or bipolar disorder, or people who have long-term or severe depression or anxiety may need to take medication for a much longer time.

Some people get side effects from medications and other people don’t. Doses can be small or large, depending on the medication and the person. Factors that can affect how medications work in people include:
Type of mental disorder, such as depression, anxiety, bipolar disorder, and schizophrenia
Age, sex, and body size
Physical illnesses
Habits like smoking and drinking
Liver and kidney function
Genetics
Other medications and herbal/vitamin supplements
Diet
Whether medications are taken as prescribed.

Source: http://www.nimh.nih.gov

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Zoloft is well tolerated and effective for the treatment of depression and certain anxiety conditions.

Zoloft is FDA approved to treat depression, certain types of social anxiety conditions, posttraumatic stress disorder (PTSD), panic disorder, obsessive-compulsive disorder (OCD), and premenstrual dysphoric disorder (PMDD) in adults over age 18. It is also approved for OCD in children and adolescents age 6-17 years.

For more than 15 years, Zoloft has safely and effectively treated millions of people with depression and certain anxiety conditions. Zoloft is available in multiple strengths, so your doctor can decide a dose for you.

Zoloft® (sertraline HCl) is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It’s approved to treat depression, social anxiety disorder, posttraumatic stress disorder (PTSD), panic disorder, obsessive-compulsive disorder (OCD), and premenstrual dysphoric disorder (PMDD) in adults over age 18. It is also approved for OCD in children and adolescents age 6-17 years.

Important Safety Information

Depression is a serious medical condition, which can lead to suicidal thoughts and behavior. Children, adolescents, and young adults taking antidepressants may be at increased risk for suicidal thoughts and behavior within the first few months of treatment. This risk must be balanced with the medical need. Those starting medication or changing doses should be watched closely for suicidal thoughts, worsening of depression, or unusual changes in mood or behavior. In children and teens, Zoloft is only approved for use in those with obsessive-compulsive disorder. A patient Medication Guide about “Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions” is available.
Zoloft is not for everyone. People taking MAOIs or pimozide shouldn’t take Zoloft. Concomitant use of Zoloft with NSAIDs or aspirin may be associated with an increased risk of bleeding. Side effects may include dry mouth, insomnia, sexual side effects, diarrhea, nausea and sleepiness. In studies, few people were bothered enough by side effects to stop taking Zoloft. Side effects may result from stopping Zoloft particularly when abrupt. You should, however, stop taking Zoloft if you get any of the following symptoms of Serotonin Syndrome, a rare but life-threatening reaction, such as fever, sweating, muscle stiffness, trouble thinking clearly, a change in mental functioning, sleepiness, or change in your breathing, heartbeat and blood pressure.
You should tell your doctor if you are pregnant or plan to become pregnant, as there is a potential risk to the fetus with Zoloft. Like many antidepressants, Zoloft can be present in breast milk so tell your doctor if you are nursing.
Zoloft is approved to treat depression, social anxiety disorder, posttraumatic stress disorder (PTSD), panic disorder, obsessive-compulsive disorder (OCD), and premenstrual dysphoric disorder (PMDD) in adults over age 18. It is also approved for OCD in children and adolescents age 6-17 years.
Zoloft is not habit-forming and is not associated with weight gain. So talk to your doctor about how Zoloft might help you. Zoloft comes in 25-mg, 50-mg, and 100-mg tablets. You and your doctor can discuss a dose for you.
Source: http://www.zoloft.com

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Overview
Paxil is the brand name for Paroxetine, a phenylpiperidine derivative. Paxil is an SSRI – Selective Serotonin Reuptake Inhibitor, which is a type of antidepressant. SSRIs work by increasing levels of serotonin (a neurotransmitter) to normal.

Paxil’s effects can usually be felt within one to four weeks.

Why is this drug prescribed?
Paxil is used primarily to treat Obsessive-Compulsive Disorder (OCD.)

Paxil is also used to treat:
depression
panic disorder / panic attacks
diabetic nerve pain (neuropathy)
chronic tension headaches
social anxiety disorder (social phobia)
premature ejaculation
premenstrual syndrome (PMS)

Warnings
The safety and effectiveness of Paxil in children under 18 years old have not been established.

Paxil is not addictive. Suddenly discontinuing Paxil may lead to withdrawal symptoms such as confusion, dizziness, sweating, or tremors. Dosage should be gradually tapered when Paxil is discontinued.

Paxil does not usually cause sedation, but patients should not drive or operate heavy machinery until it is known that Paxil does not affect the ability to safely engage in these activities.

For Pregnant or Nursing Mothers: One study showed no adverse effects due to Paxil during pregnancy, but further study is required and pregnant women are not advised to take Paxil. Paxil passes into human breast milk, and nursing mothers should not take Paxil.

Contraindications
Paxil should Not be used for people with an allergy or hypersensitivity to this drug or any SSRI.

Precautions
Paxil may be used with caution in people with the following conditions:
liver or kidney disease – lower dosage may be needed
seizures (epilepsy or convulsions) – risk of seizures is increased
a history of mania – Paxil may activate mania
elderly – lower dosage may be needed
brain disease or damage
mental retardation

Adverse Reactions
Paxil may cause the following reactions:
lowered blood pressure and fainting upon standing (postural hypotension)
sweating
dry mouth
nausea
headache
drowsiness
sedation
nervousness
insomnia
constipation
weakness
loss of appetite
taste disorders
tingling in hands
upset stomach
dizziness
blurred vision
itching
chills
abnormal ejaculation
impotence
sexual dysfunction
diarrhea
hypomania
seizures

Interactions with Drugs and Other Substances
Drugs or substances that may interact with Paxil are:
MAO Inhibitors (within 14 days) – serious or even fatal interactions can occur when taken with Paxil
benzodiazepines, desipramine, Haldol (haloperidol), and Normodyne (labetalol) – Paxil may increase the effects of these drugs
Dilantin (phenytoin) – can decrease blood levels of Paxil and reduce its effects
Quinaglute (quinidine) and Tagamet(cimetidine) – can increase Paxil levels and lead to drug toxicity
Astemizole (Hismanal) – can lead to a serious change in heart rhythm when taken with Paxil
Ultram (tramadol) – can increase the risk of seizures when taken with Paxil
Tryptophan – can increase side effects such as sweating, nausea, and dizziness when taken with Paxil
Coumadin (warfarin) – can cause bleeding when taken with Paxil
Moclobemide (Manerex) within 3 to 7 days
Buspirone (BuSpar), Bromocriptine (Parlodel), Dextromethorphan (cough medicine), Levodopa (Sinemet), Lithium, Meperidine (Demerol), Nefazodone (Serzone), Pentazocine (Talwin), other SSRIs (such as: Citalopram [Celexa], fluoxetine [Prozac], fluvoxamine [Luvox], sertraline [Zoloft]), LSD, MDMA (ecstasy), marijuana, Sumatriptan (Imitrex), Tramadol (Ultram), Trazodone (Desyrel), Tryptophan, Venlafaxine (Effexor) – taking these medicines with Paxil can increase the chance of developing a rare, but very serious, unwanted effect known as the serotonin syndrome, whose symptoms include confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, or twitching.

Source: http://whatmeds.stanford.edu/medications/paroxetine.html

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