Antipsychotics

What are antipsychotics used for?

Antipsychotics are usually used to help treat people with schizophrenia and similar conditions such as psychosis. They are also used to treat other problems such as mania, hypomania and mood disorders. Occasionally antipsychotics are used to help manage agitation or anxiety. Medicines are often used to treat more than one condition, so if you are not sure why you have been prescribed an antipsychotic, you should discuss this with your doctor.

Antipsychotics are classified into two groups, ‘typical’ or ‘first-generation’ antipsychotics and ‘atypical’ or ‘second generation’ antipsychotics. Examples of ‘typical antipsychotics’ include, haloperidol, chlorpromazine and flupentixol. Examples of ‘atypical antipsychotics’ include risperidone, olanzapine, clozapine and aripiprazole. The difference between the two groups includes the type and frequency of the side effects that they may cause.

What are the benefits of taking antipsychotics?

People with schizophrenia or psychosis may have a range of symptoms that are often thought of in two groups – ‘positive’ and ‘negative’ symptoms. Positive symptoms include hallucinations and delusions, which can include symptoms such as hearing voices, or experiencing ‘strange things’ such as seeing or feeling things that may not be real or having mistaken beliefs. People may also feel suspicious or paranoid, or feel that other people can read their thoughts. Negative symptoms are less noticeable than positive symptoms, and include tiredness, lack of concentration and lack of energy. People may become quite inactive and withdrawn from normal everyday activities.

Antipsychotics can help to treat some of these symptoms and keep them under control in the long term. Treating these symptoms should help people feel less confused, anxious and restless, and help them to think more clearly. This will help them to cope better with the stresses of everyday life, and help them to return to normal activities such as work or hobbies. Antipsychotics may also help people engage better with other kinds of therapies such as psychological treatments and therefore allow for a better response.

How quickly do antipsychotics work?

Antipsychotics work over a period of weeks. People may find that they feel calmer soon after starting treatment, but it may take several weeks until they have their full effect. Not everybody benefits from antipsychotics but most people do. If you do not feel any benefit or improvement in your symptoms after six to eight weeks, you should discuss this with your doctor or healthcare worker.

What are the usual doses of antipsychotics and how should I take them?

People will usually be started on a low dose, which will then slowly be increased to the usual effective dosage range for that medicine. Refer to the manufacturer’s patient information leaflet for the antipsychotic that you have been given. Do not change your dose of medication without checking with your doctor, as it can affect your response to the medication, or may be harmful.

What should I do if I miss a dose?

You will get the most out of your medication when taken correctly and regularly. If you miss, or forget a dose at your usual time, but remember within an hour or two take it straight away. If it is longer than this just leave out the missed dose and take the next dose at the usual time. Never take extra medication at the next dose. If you find it difficult to remember taking medication speak to your pharmacist or healthcare worker.

For how long should I take antipsychotics?

Your doctor will discuss with you how long you will need to take medication for, which will vary depending on the type of illness you have. Some people may need to take medication for a number of years and others need to stay on medication longer. Taking medication regularly may prevent you from becoming unwell. Your doctor should regularly review your medication to check whether you are experiencing any unwanted effects and make sure that your dose is still right for you. Stopping antipsychotics suddenly may cause ‘discontinuation symptoms’ such as jerky movements and nausea. Your original symptoms may also return after three to six months of stopping. The dose should usually be reduced gradually before stopping. Check with your doctor for advice about this. Antipsychotics are not addictive.

What are the side effects of antipsychotics?

As with all medicines there is a risk of unwanted effects (side effects). Some can occur soon after starting treatment so you may experience these before you feel better. Most are temporary and should go away after a few days or weeks. Not everyone will get side effects and people experience them to different degrees. If you feel that you have side effects that are causing you discomfort, discuss this with your doctor, pharmacist, nurse or healthcare worker. The table on the following page lists some of the main recognised side effects of antipsychotics but these will depend on the individual antipsychotic you are taking.

What about alcohol and ‘street’ drugs?

Both alcohol and antipsychotics can affect the brain so it is not recommended that you drink alcohol while taking antipsychotics. Drinking alcohol can make psychosis worse and in combination with antipsychotics can cause severe drowsiness. Once you are used to the medication and know the effects of taking alcohol you may be able to drink alcohol occasionally and in small amounts. It is good to be cautious because alcohol affects people in different ways, especially when taking medication.

Do not stop taking your medication because you feel like drinking alcohol. If you drink alcohol, drink only small amounts. Never drink alcohol and drive while taking medication.

‘Street’ drugs (for example, cannabis, ecstasy, speed, heroin and cocaine) can often also make psychosis worse. People taking ecstasy whilst on antipsychotics are more likely to experience movement disorders. There is very little information on taking antipsychotics with other ‘street’ drugs, so the effect and safety of doing this is unknown. It is best if you do not take ‘street’ drugs whilst taking antipsychotics. You may need to get advice and support to help you do this.

What about other medicines?

If you take any other medicines or herbal remedies including any that have been newly prescribed or bought, it is important to check with your doctor or pharmacist that they are safe with antipsychotics. You must take particular care when taking drugs that lower your blood pressure with antipsychotics.

When should I be cautious?

It is usually safe to take antipsychotics regularly, as prescribed by your doctor, but they are not suitable for everyone. If any of the following situations apply to you, you should tell your doctor immediately.

1 If you are allergic to antipsychotics (if you have taken it before and developed a rash, itching, swollen mouth or throat);

2 If you have diabetes, epilepsy (or have had a fit in the past), suffer from kidney disease, heart problems or have had a stroke;

3 If you have Parkinson’s disease or take any medicines usually used to treat this;

4 If you have an abnormal heart rate or take medicines to control your heart rate;

5 If you have ever had a history of breast cancer or a prolactin dependent tumour;

6 If you have phaeochromocytoma (a tumour of the adrenal gland);

7 If you are pregnant, or are planning to become pregnant; or

8 If you are breastfeeding.

Please refer to the manufacturer’s patient information leaflet that comes with your medicine for more information and the full list of side effects and precautions. If you have any questions or concerns about your medicines, or if you are worried about anything you think might be a side effect, ask your doctor, pharmacist or nurse.

This leaflet gives you some information about this medicine. It does not replace the expertise or judgement of a doctor, pharmacist or other healthcare professional. It is not a manufacturer’s patient information leaflet and is not to be taken as a substitute for, or an endorsement of, the manufacturer’s information or advice in respect of any medicine referred to in this leaflet. You might find more information in other leaflets or books, or on the internet but remember, the internet is not always accurate.

Whilst every care has been taken in the compilation of this leaflet, CNWL is not responsible for any loss or damage howsoever caused as a result of any inaccuracy or error contained in this leaflet, including (for the avoidance of doubt) in relation to breach of contract, misrepresentation or negligence whether of CNWL or any other person; but nothing in this leaflet shall exclude or restrict liability for death or personal injury resulting from negligence.

The information given in this leaflet is current as at the publication date.

This leaflet has been written by Central and North West London Mental Health NHS Trust Pharmacy Department, 30 Eastbourne Terrace, London W2 6LA www.cnwl.org – Publication Date: May 2007

Source: http://beh.zedcore.com

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(Including Selective Serotonin Reuptake Inhibitors or SSRIs; Selective or Serotonin/Norepinephrine Reuptake Inhibitors or SNRIs)

BRAND NAMES (generic names):

SSRIs (Selective Serotonin Reuptake Inhibitors*)

1. Akarin (citalopram)

2. Apo-Sertral (sertraline)

3. Aropax (paroxetine)

4. Asentra (sertraline)

5. Celexa (citalopram)

6. Cipralex (escitalopram)

7. Cipram (citalopram)

8. Cipramil (citalopram)

9. Citopam (citalopram)

10. Deroxat (paroxetine)

11. Dumyrox (fluvoxamine)

12. Eufor (fluoxetine)

13. Faverin (fluvoxamine)

14. Floxyfral (fluvoxamine)

15. Fluctine (fluoxetine)

16. Fluocim (fluoxetine)

17. Fluox (fluoxetine)

18. Fluvox (fluvoxamine)

19. Gladem (sertraline)

20. Ladose (fluoxetine)

21. Lexapro (escitalopram oxalate)

22. Lovan (fluoxetine)

23. Lustral (sertraline)

24. Luvox (fluvoxamine)

25. Paroxat (paroxetine)

26. Paxil (paroxetine)

27. Pexeva (paroxetine)

28. Prisdal (citalopram)

29. Prozac (fluoxetine hydrochloride)

30. Psiquial (fluoxetine)

31. Sarafem (fluoxetine hydrochloride)

32. Sercerin (sertraline)

33. Serlift (sertraline)

34. Seroplex (escitalopram)

35. Seroplexa (escitalopram)

36. Seropram (paroxetine)

37. Seroxat (paroxetine)

38. Sipralexa (escitalopram)

39. Tolrest (sertraline)

40. Veritina (fluoxetine)

41. Zoloft (sertraline hydrochloride)

42. Xydep (sertraline)

SNRIs (Serotonin-norepinephrine reuptake inhibitors*)

1. Ariclaim (duloxetine)

2. Cymbalta (duloxetine)

3. Dalcipran (milnacipran)

4. Dobupal (venlafaxine)

5. Efectin (venlafaxine)

6. Effexor (venlafaxine)

7. Ixel (milnacipran)

8. Pristiq (desvenlafaxine)

9. Yentreve (duloxetine)

SNRIs (Selective norepinephrine reuptake inhibitors*)

1. Edronax (reboxetine)

2. Outonin (nefazodone)

3. Merital (nomifensine)

4. Norebox (reboxetine)

5. Serzone (nefazodone)

6. Strattera (atomoxetine)

7. Vestra (reboxetine)

NDRIs (Norepinephrine-Dopamine Reuptake Inhibitors*)

1. Odranal (bupropion)

2. Wellbutrin (bupropion)

3. Zyban (bupropion)

OTHER

1. Desyrel (trazodone) 2. Dutonin (nefazodone) 3. Ludiomil (maprotiline hydrochloride) 4. Nedafar (nefazodone) 5. Serzone (nefazodone) 6. Symbyax (fluoxetine and olanzapine – antidepressant/antipsychotic mix)

SIDE EFFECTS:

§ Abnormal bleeding or bruising

§ Abnormal thoughts

§ Agitation

§ Akathisia (severe

§ restlessness)

§ Anxiety

§ Black and tarry stools

§ Blisters

§ Blood in stools

§ Bloody vomit

§ Blurred or changes in vision

§ Burning or tingling in the hands, arms, feet, or legs

§ Burping

§ Changes in ability to taste food

§ Changes in sexual desire or ability

§ Chest pain

§ Coma

§ Confusion

§ Constipation

§ Cough

§ Dark colored urine

§ Delusions

§ Diarrhea

§ Difficult, frequent, or painful urination

§ Difficulty breathing or swallowing

§ Difficulty concentrating

§ Dizziness or faintness

§ Drowsiness

§ Dry mouth

§ Emotional numbing

§ Enlarged pupils (black circles in the middle of the eyes)

§ Eye pain or redness

§ Fast, pounding, or irregular heartbeat

§ Fever

§ Flu-like symptoms

§ Flushing

§ Forgetfulness

§ Gas or bloating

§ Hallucinations

§ Headache

§ Heart attacks

§ Heartburn

§ Hives

§ Hoarseness

§ Hostility

§ Hot flashes or flushing

§ Hypomania (abnormal excitement)

§ Impotence

§ Increased appetite

§ Increased sweating

§ Indigestion

§ Insomnia

§ Itching

§ Joint pain

§ Loss of appetite

§ Lump or tightness in throat

§ Mania

§ Memory lapses

§ Mood swings

§ Muscle weakness or tightness

§ Nausea

§ Nervousness

§ Neuroleptic Malignant Syndrome*

§ Nightmares

§ Numbness in your hands, feet, arms, or legs

§ Pain in the back, muscles, joints, or anywhere in the body

§ Pain in the upper right part of the stomach

§ Painful erection that lasts for hours

§ Painful or irregular menstruation

§ Panic attacks

§ Paranoia

§ Problems with coordination

§ Problems with teeth

§ Psychotic episodes

§ Rash

§ Restlessness

§ Ringing in the ears

§ Runny nose

§ Seizures

§ Sensitivity to light

§ Sexual dysfunction

§ Slow or difficult speech

§ Small purple spots on the skin

§ Sneezing

§ Sore throat, fever, chills, and other signs of infection

§ Stomach pain

§ Sudden muscle twitching or jerking that can’t be controlled

§ Sudden upset stomach

§ Suicidal thoughts or behavior

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

§ Swelling, itching, burning, or infection in the vagina

§ Tightness in hands and feet

§ Twitching

§ Uncontrollable shaking of a part of the body

§ Violent behavior

§ Vomiting

§ Vomiting material that looks like coffee grounds

§ Weakness or numbness of an arm or leg

§ Weakness or tiredness

§ Weight gain

§ Weight loss

§ Withdrawal symptoms include deeper depression

§ Yellowing of the skin or eyes30

Explanatory Note:

The newer antidepressants, Selective Serotonin Reuptake Inhibitors (SSRIs) emerged in the late 1980s/1990s, marketed as being capable of selectively targeting a chemical—serotonin—in the brain that was theorized to influence depression. This has remained a theory only. Serotonin (of which about only 5% is found in the brain) is one of the chemicals by which brain cells signal each other. SSRIs prevent serotonin from being naturally reabsorbed and thus create continued stimulation of cells. Norepinephrine is a hormone secreted by the adrenal gland that increases blood pressure and rate and depth of breathing, raises the level of blood sugar, and decreases the activity of the intestines.

Norepinephrine is very similar to its cousin, adrenaline. Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) boost levels of norepinephrine in addition to serotonin.

There is another SNRI, which is called Selective Norepinephrine Reuptake Inhibitors, and is largely prescribed for “ADHD” but carries the same suicide warning as SSRIs and other antidepressants. Norepinephrine-Dopamine Reuptake Inhibitors (NDRIs) are said to influence norepinephrine and dopamine, another chemical messenger that is similar to adrenaline. There are no physical tests or scientific evidence to substantiate the theory that a chemical imbalance in the brain causes depression or any mental disorder.

Wellbutrin is a short-acting antidepressant and amphetamine-like drug similar to Ritalin and Dexedrine.

Strattera (atomoxetine) increases norepinephrine and dopamine in the frontal part of the brain and is a Selective NRI. The precise mechanism by which atomoxetine produces its effects on so-called ADHD is unknown.

General Warnings And Studies On Newer Antidepressants :

1997: Candace B. Pert, Research Professor at Georgetown University Medical Center in Washington, D.C., and credited as one of the researchers that helped develop Prozac, wrote that SSRIs “may also cause cardiovascular problems in some susceptible people after longterm use, which has become common practice despite the lack of safety studies.” In 2002, she added, “They are supposed to help but they actually cause violence. There’s scientific literature that supports that.”31

March 22, 2004: The FDA warned that SSRIs could cause “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania [abnormal excitement] and mania [psychosis characterized by exalted feelings, delusions of grandeur].”32

August 20, 2004: A Columbia University review of the pediatric clinical trials of Zoloft, Celexa, Effexor, Paxil, Prozac and another older antidepressant, found that young people who took them could experience suicidal thoughts or actions.33

2004: The British Healthcare Products Regulatory Authority (MHRA, similar to the FDA) issued guidelines that children should not be given most SSRIs because clinical trial data showed an increased rate of harmful outcomes, including hostility.34

October 15, 2004: The FDA ordered pharmaceutical companies to add a “black box” warning to all antidepressants because the drugs could cause suicidal thoughts and actions in children and teenagers. The agency also directed the manufacturers to print and distribute medication guides with every antidepressant prescription and to inform patients of the risks.35

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.36

December 2004: The Australian Therapeutic Goods Administration said children and adolescents prescribed SSRI antidepressants should be carefully monitored for the emergence of suicidal ideation. In a study involving Prozac, it said, there was an increase in adverse psychiatric events (acts and thoughts of suicide, self-harm, aggression and violence).37

December 9, 2004: The European Medicines Agency’s Committee for Medicinal Products

for Human Use, representing 25 European countries, recommended that product information

should be changed for antidepressants (including SSRIs, SNRIs) to warn of the risk of

suicide-related behavior in children and adolescents and of withdrawal reactions when

stopping treatment. This was reaffirmed in April 2005, warning that the drugs increased

suicide-related behavior and hostility in young people.38

February 18, 2005: A study published in the British Medical Journal determined that

adults taking SSRI antidepressants were more than twice as likely to attempt suicide as

patients given placebo (a substance with no real effect; it contains no active ingredients

and is given to a patient in a clinical trial to assess and compare the performance of a new

drug).39

July 16, 2005: The British Medical Journal published a study, “Efficacy of antidepressants

in adults,” by Joanna Moncrieff, senior lecturer in psychiatry at University College London

who found that antidepressants, especially SSRIs, were no more effective than placebo and

did not reduce depression. In a media interview Dr. Moncrieff stated, “The bottom line is

that we really don’t have any good evidence that these drugs work.” 40

August 2005: The Australian Therapeutic Goods Administration found a relationship

between SSRIs and suicidality, akathisia (severe restlessness), agitation, nervousness and

anxiety in adults. It also determined that similar symptoms could occur during withdrawal

from the drugs.41

August 19, 2005: The European Medicines Agency’s Committee for Medicinal Products

for Human Use issued its strongest warning against child SSRI antidepressant use, stating

that the drugs caused suicide attempts and thoughts, aggression, hostility, oppositional

behavior and anger.42

August 22, 2005: Norwegian researchers determined that patients taking SSRI

antidepressants were seven times more likely to experience suicide than those taking

placebo.43

May 1, 2006: An American Journal of Psychiatry study revealed that elderly people

prescribed SSRI antidepressants such as Prozac, Paxil and Zoloft are almost five times

more likely to commit suicide during the first month on the drugs than those given other

classes of antidepressants.44

July 19, 2006: The FDA warned that migraine sufferers should not take SSRI or SNRI

antidepressants while taking migraine drugs known as triptans as it could result in a lifethreatening

condition called serotonin syndrome. Serotonin syndrome occurs when the

body has too much serotonin; symptoms may include restlessness, hallucinations, loss of

coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature,

overactive reflexes, nausea, vomiting, and diarrhea. Serotonin syndrome may be more

likely to occur when starting or increasing the dose of a triptan, SSRI or SNRI, according

to the FDA.45

May 2, 2007: The FDA officially extended the age group for the black box warning about

antidepressants inducing suicide from 18 to 24.46

January 2008: The Pharmacovigilance Working Party (advises on the safety and adverse

reactions of medicinal products authorized for use in the European Union) recommended

an update to product labeling and all antidepressant patient information leaflets to warn

about the increased risk of suicide in children and young adults taking them.47

January 22, 2008: The Annals of Pharmacotherapy published a study on the risk of

cerebrovascular (of or relating to the brain and the blood vessels that supply it) events

(CVE) associated with antidepressant use and found that a “24% increased risk of a CVE

was noted in patients with current exposure to selective serotonin-reuptake inhibitors…

34% increased risk for current exposure to tricyclic antidepressants (older form of

antidepressant)… and 43% increased risk for current exposure to other antidepressants.”48

February 5, 2008: Britain’s Medicines and Healthcare Products Regulatory Agency

advised that antidepressant manufacturers would be required to update warnings about

suicidal thoughts and behavior to align with EU agreements, as noted above in January

2008.49

February 26, 2008: Public Library of Science (PLoS) published an antidepressant efficacy study, which found that at moderate levels of depression there was virtually no difference

between antidepressants and placebo. Further, there was only a relatively small difference

for patients with very severe depression. The study concluded: “increased benefit for

extremely depressed patients seems attributable to a decrease in responsiveness to placebo,

rather than an increase in responsiveness to medication.”50

March 2008: Researchers conducted a study monitoring the daily news for accurate

scientific data regarding the theory that depression is caused by a chemical imbalance

and found there was no evidence to support it. Jeffrey Lacasse, a Florida State University

doctoral candidate and visiting lecturer in the College of Social Work, and Jonathan Leo, a

neuroanatomy professor at Lincoln Memorial University in Tennessee, found that reporters

were unable to cite or provide any evidence to substantiate that a chemical imbalance

or lack of serotonin caused depression, requiring antidepressants. Further, “[T]here are

few scientists who will rise to its defense, and some prominent psychiatrists publicly

acknowledge that the serotonin hypothesis is more metaphor than fact.” As such, SSRIs

cannot correct an imbalance that does not exist. The researchers said the popularity of the

theory was in large part based on the presumed efficacy of the SSRIs, but that several large

studies now cast doubt on this efficacy. 51

January 2009: The FDA issued a letter requiring the manufacturers of Paxil, to update

their drug safety label to include information on Serotonin Syndrome or Neuroleptic

Malignant Syndrome -like reactions associated with selective serotonin reuptake inhibitors

and serotonin norepinephrine reuptake inhibitors.

Warnings Against newer antidepressants Ta ken During Pregnancy:

February 5, 2005: An analysis of World Health Organization medical records found that infants whose mothers took SSRI antidepressants while pregnant could suffer withdrawal effects.53

September 7, 2005: The Australian Therapeutic Goods Administration warned that SSRI antidepressant use during pregnancy could cause “withdrawal effects that can be severe or life-threatening.”54

September 27, 2005: The FDA warned that Paxil and other SSRI antidepressants taken during the first trimester of pregnancy could cause increased risk of major birth defects, including heart malformations in newborn infants.55

February 6, 2006: A study published in the Archives of Pediatrics and Adolescent Medicine determined that nearly one-third of newborn infants whose mothers took SSRI antidepressants during pregnancy experienced withdrawal symptoms that included highpitched crying, tremors and disturbed sleep.56

March 10, 2006: Health Canada issued a warning that pregnant women taking SSRIs and other newer antidepressants placed newborns at risk of developing a rare lung and heart condition.57

October 2007: A study released at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry showed that babies born to mothers who took antidepressants during pregnancy had high levels of cortisol (hormone that helps manage blood pressure) in umbilical cord-blood at birth and that the mothers were more likely to experience delivery complications. When examined at two weeks of age, these infants were more excitable than those born to women who did not take antidepressants.58

May 6, 2008: The results of a study of 200 pregnant women, was presented at the

annual meeting of the American Psychiatric Association. About half of the women were

diagnosed with depression, and half of these took SSRIs throughout pregnancy. About

23% of those who took SSRIs gave birth to pre-term babies at a rate that was nearly four

times that experienced by women (6%) who did not take antidepressants or did not have

depression.59

WARNINGS ON SPECIFIC newer antidepressants:

CYMBALT A (duloxetine, SNRI):

June 30, 2005: The FDA warned that Cymbalta could increase suicidal thinking or behavior

in pediatric patients taking it.60

October 17, 2005: The FDA ordered Eli Lilly & Co. to add a warning to the packaging of

Cymbalta that it could cause liver damage.61

October 2, 2007: The FDA faxed Eli Lilly & Co. about its professional mailer for Cymbalta,

stating that it was “false or misleading in that it overstates the efficacy of Cymbalta and

omits some of the most serious and important risk information associated with its use.”62

PAXIL (paroxetine, SSRI):

September 27, 2005: The FDA warned that Paxil taken by pregnant women in their first

trimester might cause birth defects, including heart malformations.63

May 12, 2006: GlaxoSmithKline, the manufacturer of Paxil, wrote to doctors warning that

Paxil increased the risk of suicide in adults.64

January 29, 2008: The Canadian Medical Association Journal published a study on the

effectiveness of Paxil that involved data from 40 trials and “showed an absence of a positive

effect of paroxetine [Paxil].”65

STRATTERA (atomoxetine, SNRI):

Often prescribed to treat ADHD as well as depression.

December 17, 2004: The FDA required that Strattera packaging carry a new warning

advising, “Severe liver injury may progress to liver failure resulting in death or the need

for a liver transplant in a small percentage of patients.”66 The drug should be discontinued

in patients who develop jaundice (condition that causes yellowness of the skin, eyes and

body fluids) or liver injury. The FDA also noted, “The labeling warns that severe liver

injury may progress to liver failure resulting in death or the need for a liver transplant in

a small percentage of patients.”67 Signs of the possible liver problems included jaundice,

dark urine, unexplained flu-like symptoms, upper right-side abdominal tenderness and a

form of itchy skin known as pruritus (caused by irritation of the sensory nerve endings).68

Other common side effects were headache, abdominal pain, nausea and vomiting, anorexia

(eating “disorder”) and weight loss, nervousness, somnolence (drowsiness).69

September 29, 2005: The FDA directed Eli Lilly & Co. to revise Strattera labeling to

include a boxed warning about the increased risk of suicidal thinking in children and

adolescents taking it.70

July 2008: Health Canada published an article entitled “Atomoxetine [Strattera] and

suicidal behavior: update” in its Canadian Adverse Reaction Newsletter, stating that as of

December 2007, 1989 adverse reactions had been reported. Of these, 55 were classified

as suicide attempt with about 75% of those being children. They stressed that health care

providers needed to remind patients and family members to monitor moods, behaviors,

thoughts and feelings when ADHD medication was used.71

March 2009: The Medicines and Healthcare products Regulatory Agency (UK) published

in their Drug Safety Update newsletter new information about atomoxetine (Strattera, a

non-stimulant ADHD drug). They warned that atomoxetine is associated with treatmentemergent

psychotic or manic symptoms in children without a history of such disorders.72

WELLBUTRIN (bupropion):

The FDA approved Wellbutrin as an antidepressant in 1985 but because of the significant

incidence of seizures at the originally recommended dose (400-600 mg), the drug was

withdrawn in 1986. It was reintroduced in 1989 with a maximum dose of 450 mg per

day. In 1996, the FDA approved a sustained release (taken twice daily) for treatment of

depression. The same drug is marketed in slow-release form as Zyban for people trying

to quit smoking.73 While Wellbutrin is not FDA-approved to treat ADHD, doctors still

prescribe it for this.

It can cause seizures and at rates of four times that of other antidepressants.74 Fatal heart

attacks in those with a history of heart-rhythm disturbances have occurred.75 Other side

effects include agitation, insomnia, increased restlessness, anxiety, delusions, hallucinations,

psychotic episodes, confusion, weight loss and paranoia.76 Teens have abused the drug by

crushing and snorting it, causing seizures.77

*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

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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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Use:
Anticonvulsant, antimanic agent. Epilepsy: Adults and children > 12 years – initially, 100-200 mg once or twice a day; increased in divided doses until best response obtained. Optimal daily dosage: 800-1200 mg. Rarely, some adults may require 1600 mg/day. As soon as disappearance of seizures has been obtained and maintained, reduce dosage very gradually to minimum effective dose. Children 6-12 years: Initially, 100 mg in divided doses on first day; increased by 100mg/day until best response obtained. Maximum daily dosage: 1000mg.

Trigeminal neuralgia: Initially, 100 mg twice daily; increased by 200 mg/day until pain is relieved, usually at 200-800 mg/day (occasionally, 1200 mg/day). Reduce or discontinue Tegretol, if possible, at intervals of not more than 3 months.

Mania and bipolar disorders: Initially, 200-400 mg/day in divided doses (400-600 mg/day may be used in acute mania); increased gradually until symptoms are controlled or a total daily dose of 1600 mg is achieved. Usual dose is 400-1200 mg/day in divided doses.

With lithium, neuroleptics: start with 100-200 mg/day and increase gradually. Daily dose > 800 mg is rarely required.

Tegretol tablets, Chewtabs and suspension: Take in 2-4 divided doses daily, with food. CR tablets may be divided or swallowed unchewed with liquid during or after a meal. Suspension: Start with low doses and increase slowly to avoid adverse reactions. When switching from tablets to suspension, give the same amount of drug daily, but in smaller, more frequent doses (i.e. twice daily tablets could be switched to 3 times daily suspension).

Contraindications:
AV block, hepatic disease, a history of bone marrow depression, acute intermittent porphyria or serious blood disorders. Hypersensitivity to carbamazepine or tricyclics. Not to be given with, or within 14 days of starting or stopping MAOI therapy.

Precautions:
Pregnancy, lactation: Weigh possible risks vs. potential benefits. Elderly patients. Urinary retention, increased intraocular pressure, cardiovascular disorders, activation of behavioral disorders, exacerbation of seizures. Perform periodic ophthalmic examinations, evaluations of renal, hepatic and bone marrow function. Abrupt cessation of Tegretol may precipitate seizures. Cross-hypersensitivity with phenytoin and oxcarbazepine.

Side effects:
Drowsiness, headache, ataxia, vertigo, fatigue, diplopia, dizziness, nausea, vomiting, allergic skin reactions, edema, fluid retention, dry mouth, leucopenia, eosinophilia. Rarely, serious hematologic, hepatic, cardiovascular and dermatologic reactions (stop therapy).

Interactions:
Se Contraindications. Plasma levels of carbamazepine increased by macrolide antibiotics, isoniazid, verapamil, danazol, fluvoxamine, grapefruit juice, azole antifungals, loratadine, ritonavir, diltiazem, fluoxetine, cimetidine. Carbamazepine may lower plasma levels of anticonvulsants, oral contraceptive, oral anticoagulants, digoxin, cyclosporine, levothyroxine, dehydropyridine calcium channel blockers, doxycycline, TCAs, estrogens/progestrogens, corticosteroids, benzodiazepines, haloperidol, protease inhibitors for HIV treatment, olanzapine, risperidone. Plasma levels of carbamazepine may be reduced by phenytoin, Phenobarbital, rifampin, oxcarbazepine, St.John’sWort, valproic acid, phesuximide. Combined use of carbamazepine with lithium or haloperidol may increase risk of neurotoxic side effects.

Patient tips:
Avoid alcoholic beverages. Call physician immediately if seizures worsen. Caution re drowsiness, dizziness (NB driving).

Supplied:
200 mg tablets, 100 mg and 200 mg Chewtabs, 200 mg and 400 mg CR (controlled-release) tablets, 100 mg/5mL oral suspension.

Source: http://www.mentalhealth.com/drug/p30-t01.html

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Antipsychotics can be classified by their structure but can also be distinguished by their pharmacology, their action at receptors, and by their clinical properties. Typical (also called conventional) antipsychotics act primarily at dopamine receptors. Atypical antipsychotics act on other receptors as well as dopamine, and are less likely than typical antipsychotics to cause movement disorders as a side effect. The following are atypical antipsychotics are licensed in the UK: amisulpiride (brand name Solian), aripiprazole (Abilify), clozapine (Clozaril), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal) and zotepine (Zoleptil).

As with all effective medicines antipsychotics can produce side effect in some individuals. The most common side effects include movement disorders that may resemble Parkinson’s disease (referred to as extrapyramidal effects, anticholinergic effects such as dry mouth, feelings of dizziness or light headedness, constipation and blurred vision (so called as they are due to the action of these drugs on cholinergic receptors in the brain and body) and weight gain.

It is important to appreciate that this is not a comprehensive list of the possible side effects of antipsychotics. Full guidance on prescribing and use, including possible side effects, of antipsychotics is provided in the Summary of Product Characteristics (SPC) for health professionals and the patient information leaflet (PIL) that should accompany the medicine.

More recently concerns have arisen that patients receiving risperidone and olanzapine in dementia were at an increased risk of stroke compared with patients receiving placebo (dummy pill) and that the balance of risks and benefits was considered to be unfavourable in the dementia population. Atypical antipsychotics are not authorised for the treatment of dementia related psychosis and/or behaviour disturbances. Prescribers were informed of this risk and advised to review the treatment of all patients receiving atypical antipsychotics in dementia as the risk of stroke for other atypical antipsychotics could not be excluded:
Source: http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Antipsychoticdrugs/index.htm

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