FDA Drug Safety Communication: Serious CNS reactions possible when methylene blue is given to patients taking certain psychiatric medications

Safety Announcement

[07-26-2011] The U.S. Food and Drug Administration (FDA) has received reports of serious central nervous system (CNS) reactions when the drug methylene blue is given to patients taking psychiatric medications that work through the serotonin system of the brain (serotonergic psychiatric medications). Methylene blue is commonly used in diagnostic procedures and is also used to treat a number of medical conditions (see Facts about methylene blue box). A list of the serotonergic psychiatric medications that can interact with methylene blue can be found here.

Although the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase A—an enzyme responsible for breaking down serotonin in the brain. It is believed that when methylene blue is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome. Signs and symptoms of Serotonin Syndrome include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.

Healthcare professionals and patients may not realize that methylene blue has monoamine oxidase inhibitor (MAOI) properties. Methylene blue should generally not be given to patients taking serotonergic drugs. However, there are some conditions that may be life-threatening or require urgent treatment with methylene blue such as when it is used in the emergency treatment of:
methemoglobinemia,
ifosfamide-induced encephalopathy, or
cyanide poisoning.

Safety information about these potential drug interactions and important drug usage recommendations for emergency and non-emergency situations are being added to the drug labels for serotonergic psychiatric medications. (See Additional Information for Healthcare Professionals)

A separate Drug Safety Communication (DSC) is being released today for linezolid (Zyvox) due to similar potential drug interactions with serotonergic psychiatric medications and includes drug usage recommendations.

Health Canada issued a NOTICE TO HOSPITALS on the association of serotonin toxicity with methylene blue in combination with serotonin reuptake inhibitors on February 16, 2011.

Additional Information for Patients
You may need to temporarily stop taking your serotonergic psychiatric medication if it becomes necessary for you to take methylene blue in certain situations. Your healthcare provider will tell you when to start methylene blue after stopping your serotonergic psychiatric medication.
Do not stop taking your serotonergic psychiatric medicine without first talking to a healthcare professional.
Make sure your healthcare professional knows about all the medications you are taking. It is helpful to keep a list of all your current medications in your wallet or another location where it is easily retrieved.
Contact your healthcare professional immediately if you are taking a serotonergic psychiatric medication and develop any of the following symptoms: mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.
Discuss any questions or concerns about methylene blue or serotonergic psychiatric medications with your healthcare professional.
Report any serious side effects you experience to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of the page.

Additional Information for Healthcare Professionals
Methylene blue can interact with serotonergic psychiatric medications and cause serious CNS toxicity.
In emergency situations requiring life-threatening or urgent treatment with methylene blue (as described above), the availability of alternative interventions should be considered and the benefit of methylene blue treatment should be weighed against the risk of serotonin toxicity. If methylene blue must be administered to a patient receiving a serotonergic drug, the serotonergic drug must be immediately stopped, and the patient should be closely monitored for emergent symptoms of CNS toxicity for two weeks (five weeks if fluoxetine [Prozac] was taken), or until 24 hours after the last dose of methylene blue, whichever comes first.
In non-emergency situations when non-urgent treatment with methylene blue is contemplated and planned, the serotonergic psychiatric medication should be stopped to allow its activity in the brain to dissipate. Most serotonergic psychiatric drugs should be stopped at least 2 weeks in advance of methylene blue treatment. Fluoxetine (Prozac), which has a longer half-life compared to similar drugs, should be stopped at least 5 weeks in advance.
Treatment with the serotonergic psychiatric medication may be resumed 24 hours after the last dose of methylene blue.
Serotonergic psychiatric medications should not be started in a patient receiving methylene blue. Wait until 24 hours after the last dose of methylene blue before starting the antidepressant.
Educate your patients to recognize the symptoms of serotonin toxicity or CNS toxicity and advise them to contact a healthcare professional immediately if they experience any symptoms while taking serotonergic psychiatric medications or methylene blue.
Report adverse events involving methylene blue or serotonergic psychiatric medications to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

Data Summary

FDA has received adverse event reports from the FDA Adverse Event Reporting System (AERS) database of serious central nervous system (CNS) reactions in patients treated with serotonergic psychiatric medications who were administered methylene blue. Additional cases also have been reported in the published literature.1-3 The reported adverse events include the following: lethargy, confusion, delirium, agitation, aggression, obtundation, and coma. These symptoms were frequently accompanied by neurological symptoms, such as myoclonus, expressive aphasia, hypertonia, and seizures, or autonomic symptoms, such as pyrexia and elevated blood pressure.

Based on the available information provided in the AERS cases and literature, FDA has concluded that the concomitant administration of a serotonergic psychiatric medication with methylene blue has the potential for a drug interaction causing serotonin syndrome. It appears this potential drug interaction can also occur following the discontinuation of serotonergic psychiatric medications with long half-lives. As a result, methylene blue should generally not be given to patients taking serotonergic drugs unless the benefit is deemed to outweigh the risk.

References
Bach KK, Lindsay FW, Berg LS, Howard RS. Prolonged postoperative disorientation after methylene blue infusion during parathyroidectomy. Anesth Analg. 2004;99:1573-4.
Kartha SS, Chacko CE, Bumpous JM, Fleming M, Lentsch EJ, Flynn MB. Toxic metabolic encephalopathy after parathyroidectomy with methylene blue localization. Otolaryngol Head Neck Surg. 2006;135:765-8.
Sweet G, Standiford SB. Methylene-blue-associated encephalopathy. J Am Coll Surg. 2007;204:454-8.

Source: http://www.fda.gov/Drugs/DrugSafety/ucm263190.htm

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Beerse, Belgium (March 9, 2011) — Janssen-Cilag International NV today announced that XEPLION® (paliperidone palmitate), a once monthly, long-acting injectable, antipsychotic, has received approval from the European Commission for the treatment of schizophrenia.

 Schizophrenia is relatively common and the prevalence is similar around the world. The lifetime risk for schizophrenia is estimated to be one person in 100, and appears to be the same for men and women up to age 60 years.[1] Schizophrenia is a devastating mental illness for both the patients and their families and friends, as it seriously impairs a person’s ability to think clearly, relate to others and to function properly in society. While there is no cure, many people with the illness respond well to antipsychotic medicines, the mainstay of treatment for schizophrenia.

 However, further relapses can have a terrible effect on the lives of patients with schizophrenia and their families. Frequent relapses and hospitalisation can increase the person’s isolation and make it even more difficult for them to find and keep a job.[2],[3],[4],[5],[6] Prevention of future relapses is a crucial goal of therapy and patients who stay on continual treatment are more likely to achieve optimal outcomes.[7],[8]

 Patients with schizophrenia who are non-adherent to medication are up to five times more likely to relapse than those patients who are adherent and continue on medication, significantly increasing the likelihood of hospitalisation,[9] which in turn increases the overall cost of care.

 “Relapse can have a devastating effect on patients with schizophrenia and more needs to be done to actively improve adherence to medication if we are to break the cycle of decline,” said Professor Fernando Cañas, Head of Department of Psychiatry, Hospital Dr Rodríguez Lafora, Madrid, Spain.* “Long-acting injectable antipsychotics such as XEPLION® can help patients to maintain continual treatment, thereby reducing the likelihood of relapse. This is imperative not only to reduce the suffering and cost burden associated with relapse in schizophrenia, but to improve the future outlook and overall quality of life for these patients.”

The Clinical Data

 The efficacy of XEPLION® was established in four double-blind placebo controlled studies in patients with an acute exacerbation of schizophrenia and a longer-term double blind relapse prevention/maintenance study.[10],[11] ,[12],[13],[14] XEPLION® was superior to placebo in improving symptoms of schizophrenia as measured by the change in the positive and negative syndrome scale (PANSS) total scores from baseline to endpoint in the acute treatment trials and significantly delayed time to relapse vs. placebo in the longer-term maintenance study.[15]

 The most recent acute symptom control study was a multi-centre, randomised, placebo-controlled, double-blind, parallel-group study (n=636). [10] All patients received a dose of 150 mg eq. on Day 1 in the deltoid muscle. From Day 8 and monthly thereafter, patients were assigned to one of three fixed doses of XEPLION® (25, 100 and 150 mg eq) administered into either the deltoid or gluteal muscle for a period of 13 weeks. All three doses of XEPLION® were superior to placebo in improving the PANSS total score at endpoint (the primary measure of efficacy). The results support efficacy across the entire duration of treatment, with onset of efficacy and significant improvement in PANSS compared to placebo observed from day 8 in some patients. The results of the other studies also yielded significant results in favour of XEPLION®.[13]

 The efficacy of XEPLION® in maintaining symptomatic control and delaying relapse in schizophrenia was established in a longer-term, randomised, double-blind, placebo-controlled, flexible-dose study involving 849 patients with schizophrenia.[14] A total of 410 stabilised patients were randomised to either XEPLION® or to placebo until they experienced a relapse of schizophrenia symptoms in the variable length double-blind phase of the study. The trial was stopped early for efficacy reasons as a significantly longer time to relapse (p < 0.0001) was seen in patients treated with XEPLION® compared to placebo. During the double-blind phase of the study, fewer patients treated with XEPLION® experienced a relapse (10% [n=15/156]) compared with those in the placebo group (34% [n=53/156]).[14] The final analyses confirmed the results of the interim analysis.

 “XEPLION® provides healthcare professionals with the opportunity to rethink their overall approach to how they treat schizophrenia by using long-acting therapies,” says Dr Christophe Tessier**, Medical Affairs Director, Psychiatry, Janssen EMEA. “The approval of XEPLION® demonstrates Janssen’s ongoing commitment to providing novel therapies for schizophrenia. As a once monthly injection, XEPLION® can help healthcare professionals address the issue of non-adherence to medication thus ensuring symptom control and allowing patients to focus on shaping their lives.”

About XEPLION® (paliperidone palmitate)

XEPLION® is a once-monthly, long-acting, injectable, atypical antipsychotic. XEPLION® will be available in Europe in milligrams (mg) of paliperidone palmitate in dose strengths of 25***, 50, 75, 100 and 150 mg. After the first two initiation injections, XEPLION® can be administered in either the deltoid (arm) or gluteal (buttock) muscle.

 The approved indication is:

 XEPLION® is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, XEPLION® may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

Tolerability

 In the clinical development programme XEPLION® was generally well tolerated with no new safety signals identified in comparison to oral paliperidone ER with the exception of local injection site reactions.[10-14] The most frequently reported adverse effects during the clinical trials were insomnia (difficulty sleeping), headache, weight increase, injection site reactions, agitation, somnolence, akathisia (restlessness), nausea, constipation, dizziness, tremor, vomiting, upper respiratory tract infection (infection of the nose, throat, or chest), diarrhoea, and tachycardia (rapid heart rate).[15]

 XEPLION® was developed utilising Elan Drug Technologies’ proprietary NanoCrystal® Technology. Using this technology increases the rate of dissolution and enables the formulation of an aqueous suspension for once-monthly intramuscular administration.

About Schizophrenia

 Schizophrenia is a chronic, severe and disabling brain disorder that seriously impairs a person’s ability to think clearly, relate to others and to function productively in society. The consequences of the disorder include difficulties in thought processes leading to hallucinations, delusions, disordered thinking and unusual speech or behaviour.

About Janssen

 Janssen-Cilag International NV is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, which are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes). Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found at http://www.janssen-emea.com

 (This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Janssen-Cilag International NV’s and/or Johnson & Johnson’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2011. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen-Cilag International NV nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

 Notes

 * Professor Fernando Cañas has at times been a paid consultant of Janssen.

 ** Dr Christophe Tessier is a full time employee of Janssen, EMEA.

 *** 25mg will not be available in all countries.

 References

 ———————————

 [1] Lehman A et al. Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004;161(2 Suppl):1-56

 [2] Thornicroft G, Brohan E, Rose D, et al for the INDIGO Study Group. Lancet.2009;373(9661):408-15.

 [3] Marwaha S, Johnson S, Bebbington P, et al. Br J Psychiatry. 2007;191:30-7.

 [4] Marwaha S, Johnson S. Soc Psychiatry Psychiatr Epidemiol. 2004;39(5):337-49.

 [5] Nithsdale V, Davies J, Croucher P. J Occup Rehabil. 2008;18(2 ):175-82.

 [6] Rosenheck R, Leslie D, Keefe R, et al; CATIE Study Investigators Group. Am J Psychiatry. 2006;163(3):411-417.

 [7] Masand PS, Roca M, Turner MS et al. Partial adherence to antipsychotic medication impacts course of illness in patients with schizophrenia: a review. Prim Care Companion J Clin Psychiatry. 2009;11(4):147-54.

 [8] Peuskens J, Olivares JM, Pecenak J et al. Treatment retention with risperidone long-acting injection: 24-month results from the Electronic Schizophrenia Treatment Adherence Registry (e-STAR) in six countries. Curr Med Res Opin 2010;26:501-509

 [9] Kane JM. Treatment adherence and long-term outcomes. CNS Spectrums. 2007: 12 (10 Suppl 17), 21-26.

 [10] Pandina et al. A Randomised, Placebo Controlled Study to Assess the Efficacy and Safety of 3 Doses of paliperidone Palmitate in Adults With Acutely Exacerbated Schizophrenia. J Clin Psychopharmacol. 2010; 30: 235-244.

 [11] Nasrallah HA et al. A controlled evidence based trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia. Neuropsychopharmacology. 2010; 35(10): 207-282.

 [12] Gopal S et al. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacology. 2010; 25(5): 24756

 [13] Kramer et al. Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacology. 2009; 27: p113.

 [14] Hough D et al. Paliperidone palmitate maintenance treatment in delaying the time to relapse in patients with schizophrenia: A randomized, double-blind placebo-controlled study. Schizophrenia Research. 2010; 116 (23): 107-117.

 [15] Xeplion® SmPC 2011

Source: http://www.jnj.com/connect/news/all/european-commission-approves-xeplion-for-treatment-of-schizophrenia

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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.

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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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The U.S. Food and Drug Administration today approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.

Schizophrenia affects about 1 percent of the U.S. population, ages 18 years and older, in a given year. The most prominent symptoms include hallucinations, delusions, disordered thinking and behavior, and suspiciousness. Hearing voices that other people don’t hear is the most common type of hallucination. These experiences can make people with the disorder fearful and withdrawn.

“Schizophrenia can be a devastating illness requiring lifelong treatment,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Some patients do not respond well to certain types of drug therapy, so it is important to have multiple treatment options available.”

Latuda is included in the atypical antipsychotic class of drugs. All atypical antipsychotics contain a boxed warning alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.

Four six-week controlled studies of adults with schizophrenia demonstrated the effectiveness and safety of Latuda. In the trials, patients treated with Latuda had fewer symptoms of schizophrenia than those taking an inactive pill (placebo).

The most common adverse reactions reported by those in clinical trials were drowsiness, feelings of restlessness and the urge to move (akathisia), nausea, movement abnormalities such as tremors, slow movement, or muscle stiffness (Parkinsonism), and agitation.

Latuda is manufactured by Sunovion Pharmaceuticals Inc. of Fort Lee, N.J.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm231512.htm

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In 2002, the FDA approved the nonstimulant medication atomoxetine (Strattera) for use as a treatment for ADHD. In February 2007, the FDA approved the use of the stimulant lisdexamfetamine dimesylate (Vyvanse) for the treatment of ADHD in children ages 6 to 12 years.
What are the side effects?
Most side effects are minor and disappear when dosage levels are lowered. The most common side effects include:
Decreased appetite. Children seem to be less hungry during the middle of the day, but they are often hungry by dinnertime as the medication wears off.
Sleep problems. If a child cannot fall asleep, the doctor may prescribe a lower dose. The doctor might also suggest that parents give the medication to their child earlier in the day, or stop the afternoon or evening dose. To help ease sleeping problems, a doctor may add a prescription for a low dose of an antidepressant or a medication called clonidine.
Stomachaches and headaches.
Less common side effects. A few children develop sudden, repetitive movements or sounds called tics. These tics may or may not be noticeable. Changing the medication dosage may make tics go away. Some children also may appear to have a personality change, such as appearing “flat” or without emotion. Talk with your child’s doctor if you see any of these side effects.
How are ADHD medications taken?

Stimulant medications can be short-acting or long-acting, and can be taken in different forms such as a pill, patch, or powder. Long-acting, sustained and extended release forms allow children to take the medication just once a day before school. Parents and doctors should decide together which medication is best for the child and whether the child needs medication only for school hours or for evenings and weekends too.

ADHD medications help many children and adults who are hyperactive and impulsive. They help people focus, work, and learn. Stimulant medication also may improve physical coordination. However, different people respond differently to medications, so children taking ADHD medications should be watched closely.
Are ADHD medications safe?
Stimulant medications are safe when given under a doctor’s supervision. Some children taking them may feel slightly different or “funny.”

Some parents worry that stimulant medications may lead to drug abuse or dependence, but there is little evidence of this. Research shows that teens with ADHD who took stimulant medications were less likely to abuse drugs than those who did not take stimulant medications.14
FDA warning on possible rare side effects

In 2007, the FDA required that all makers of ADHD medications develop Patient Medication Guides. The guides must alert patients to possible heart and psychiatric problems related to ADHD medicine. The FDA required the Patient Medication Guides because a review of data found that ADHD patients with heart conditions had a slightly higher risk of strokes, heart attacks, and sudden death when taking the medications. The review also found a slightly higher risk (about 1 in 1,000) for medication-related psychiatric problems, such as hearing voices, having hallucinations, becoming suspicious for no reason, or becoming manic. This happened to patients who had no history of psychiatric problems.

The FDA recommends that any treatment plan for ADHD include an initial health and family history examination. This exam should look for existing heart and psychiatric problems.

The non-stimulant ADHD medication called atomoxetine (Strattera) carries another warning. Studies show that children and teenagers with ADHD who take atomoxetine are more likely to have suicidal thoughts than children and teenagers with ADHD who do not take atomoxetine. If your child is taking atomoxetine, watch his or her behavior carefully. A child may develop serious symptoms suddenly, so it is important to pay attention to your child’s behavior every day. Ask other people who spend a lot of time with your child, such as brothers, sisters, and teachers, to tell you if they notice changes in your child’s behavior. Call a doctor right away if your child shows any of the following symptoms:
Acting more subdued or withdrawn than usual
Feeling helpless, hopeless, or worthless
New or worsening depression
Thinking or talking about hurting himself or herself
Extreme worry
Agitation
Panic attacks
Trouble sleeping
Irritability
Aggressive or violent behavior
Acting without thinking
Extreme increase in activity or talking
Frenzied, abnormal excitement
Any sudden or unusual changes in behavior.

While taking atomoxetine, your child should see a doctor often, especially at the beginning of treatment. Be sure that your child keeps all appointments with his or her doctor.

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

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What are tricyclic antidepressants (TCAs) used for?

Tricyclic antidepressants (TCAs) are a group of medicines usually used to help treat people with depression. Medicines are often used to treat more than one condition, so if you are not sure why you have been prescribed a TCA, you should discuss this with your doctor. Types of TCAs are amitryptyline, clomipramine, dosulepin (dothiepin), imipramine, lofepramine, nortriptyline and trimipramine. Your medicine may also have a trade or brand name. This is the name that the manufacturer gives to the medicine, for example Anafranil® is a brand name for clomipramine.

What are the benefits of taking TCAs?

People with depression may feel fed up, unhappy and miserable most of the time, and this usually interferes with their everyday life. This feeling of depression is worse than short periods of unhappiness that people can experience from time to time. Restlessness, agitation and tiredness are common, as well as difficulty in sleeping and loss of appetite. People with depression may also feel hopeless and inadequate, and find it difficult to enjoy life. They may also have thoughts of harming themselves or committing suicide.

TCAs can help to treat these symptoms in people who are unwell, and may also help to keep people well in the longer term. They may also help people to cope better so that they can enjoy life and be able to deal with any problems they may have.

How quickly do TCAs work?

TCAs work over a period of weeks. Some symptoms may start to improve before others, but it may take up to four weeks until they have their full effect. Not everybody benefits from TCAs, but most people do. If you do not feel any benefit after four to six weeks, you should discuss this with you doctor or healthcare worker. Occasionally, thoughts of suicide or self-harm may increase in the first few weeks of treatment until your medicine has taken its full effect. If this happens to you tell your doctor immediately or go to the nearest hospital.

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

Refer to the manufacturer’s patient information leaflet for the TCA that you have been given. TCAs are usually started at low doses that are gradually increased, depending on how you respond to the treatment. The usual doses of some TCAs are given below, but do not change your dose of medication without checking with your doctor, as doing so may affect your response to the medication or be harmful.

• The usual dose of amitriptyline is between 150milligrams (mg) and 200mg daily.

• The usual dose of clomipramine is between 10mg and 150mg daily. The maximum dose is 250mg daily.

• The usual dose of imipramine is between 150mg and 200mg daily. The maximum dose is 300mg daily.

• The usual dose of lofepramine is between 140mg and 210mg daily usually given in two doses.

• The usual dose of nortriptyline is between 75mg and 100mg daily. The maximum dose is 150mg daily.

• The usual dose of trimipramine is between 150mg and 300mg daily.

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 to take a dose at your usual time, but remember within an hour or two then take it straight away. If it is longer than this just leave out the missed dose. Take the next dose at the usual time. If you miss a few doses you may experience ‘discontinuation’ symptoms (see below). 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 TCAs?

Your doctor will discuss with you the length of treatment, which will vary depending on the type of illness you have. It may be for a few months or longer. TCAs are usually taken for at least six months after you start to feel better. Taking medication regularly may prevent you from becoming unwell again. Your doctor should regularly review your medication to make sure that you do not take medicines for longer than needed. If you stop taking TCAs suddenly you may get unpleasant symptoms called ‘discontinuation’ or ‘withdrawal’. These are usually mild and disappear by themselves, but occasionally can cause problems. TCAs are not addictive.

What are the side effects of TCAs?

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 many 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 TCAs but the chance of experiencing each of these side effects will depend on the individual TCA that you have been prescribed.

What about alcohol or ‘street’ drugs?

Both alcohol and TCAs can affect the brain so it is not recommended that you drink alcohol while taking TCAs. Drinking alcohol can cause drowsiness and in combination with TCAs can cause severe drowsiness. Once you are used to taking medication, and know the effects of taking alcohol you may be able to drink 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) may affect your antidepressant treatment. Taking amphetamines, ecstasy and cocaine whilst taking TCAs may increase their toxicity and can cause an abnormal heart rhythm, which potentially can be very serious. Taking cannabis whilst on TCAs can cause tachycardia (a rapid heart beat). There is very little information on taking TCAs with other ‘street’ drugs and so the effect and safety of doing this is unknown. It is best if you do not take any ‘street’ drugs whilst taking TCAs. 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 TCAs.

When I should be cautious?

It is usually safe to take TCAs 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 TCAs (if you have taken one before and developed a rash, itching, swollen mouth or throat);

2 If you are taking or have recently been taking medicines called monoamine oxidase inhibitors (MAOIs), used to treat depression;

3 If you have previously had thoughts about harming yourself or committing suicide;

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

5 If you have an eye condition known as glaucoma;

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

7 If you have difficulty passing urine or have an enlarged prostate;

8 If you have episodes of mania (overactive behaviour or thoughts);

9 If you are having electro-convulsive therapy (ECT);

10 If you are an older person and have a history of falls;

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

12 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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(Called Minor Tranquilizers, Benzodiazepines or Sedative Hypnotics)

Brand Names (Generic Names):

Ambien (zolpidem)

Ativan (lorazepam)

Azene (clorazepate)

BuSpar (buspirone)

Centrax (prazepam)

Champix (varenicline – in the UK)

Chantix (varenicline – in the U.S.)

Dalmane (flurazepam)

Doral (quazepam)

Equanil (meprobamate)

Halcion (triazolam)

Klonopin (clonazepam)

Lexomil (bromazepam)

Lexotan (bromazepam)

Lexotanil (bromazepam)

Librax (chlordiazepoxide and flidinium)

Libritabs (chlordiazepoxide)

Librium (chlordiazepoxide)

Lunesta (eszopiclone)

Miltown (meprobamate)

Niravam (alprazolam)

Paxipam (halazepam)

Placidyl (ethchlorvynol)

Prosom (estazolam)

Reapam (prazepam)

Restoril (temazepam)

Rivotril (clonazepam)

Rohypnol (flunitrazepam)

Rozerem (ramelteon)

Serax (ozazepam)

Serepax (oxazepam)

Serestra (oxazepam)

Sonata (zaleplon)

Stesolid (diazepam)

Stilnox (zolpidem)

Temesta (lorazepam)

Tranxene (clorazepate)

Valium (diazepam)

Valrelease (diazepam)

Versed (midazolam)

Verstran (prazepam)

Vistaril (hydroxyzine)

Xanax (alprazolam)

Side Effects:

Acute hyperexcited states

Aggressive behavior

Agitation

Agranulocytosis (condition affecting white blood cells causing susceptibility to infection)

Akathisia

Amnesia

Anxiety

Blurred vision

Changes in appetite

Changes in sex drive or ability

Chest pain

Confusion

Constipation

Diarrhea

Difficulty urinating

Disorientation

Dizziness or lightheadedness

Drowsiness

Dry mouth

Epileptic seizures and death have resulted from suddenly stopping

Fast or irregular heartbeat

Fatigue

Fear

Feeling that the throat is closing

Fever

Frequent urination

Hallucinations

Hangover effect (grogginess)

Headache

Heartburn

Hives

Hoarseness

Hostility

Increased salivation

Insomnia

Irritability

Itching

Jaundice

Jaw, neck, and back muscle spasms

Lethargy

Liver problems

Memory impairment

Muscle tremors

Nausea

Nervousness

Nightmares

Numbness

Problems with coordination

Psychosis

Rage

Restlessness or excitement

Sedation

Seizures

Severe depression

Severe skin rash

Sexual problems

Shuffling walk

Sleep disturbances

Slow or difficult speech

Slurred speech

Stomach pain

Suicide attempt

Swelling of the eyes, face, lips, tongue, or throat

Talkativeness

Tiredness

Transient amnesia

Tremors

Unusual movements of the head or neck muscles

Upset stomach

Vomiting

Weakness

Weight changes115

General Warnings And Studies On Anti-Anxiety Drugs:

Daily use of therapeutic doses of benzodiazepines is associated with physical dependence.

Addiction can occur after 14 days of regular use.116 The withdrawal from drugs like Valium

“is more prolonged and often more difficult than [withdrawal from] heroin,” Dr. Conway

Hunter, Jr. of Atlanta’s Peachford Hospital stated in 1979. In 2008, Dr. Patrick Holford

from the UK wrote “How To Quit Tranquilizers” and said, withdrawal and tolerance to

benzodiazepines “describe an addiction that can be as difficult as heroin to break.”117

The typical consequences of withdrawal are anxiety, depression, sweating, cramps,

nausea, psychotic reactions and seizures. There is also a “rebound effect” where the

individual experiences even worse symptoms than they started with as a result of chemical

dependency.118

1990-1996: Benzodiazepines caused 1,810 deaths in Britain, making them more lethal

than heroin, cocaine and methadone, which combined accounted for 1,623 deaths.119

1997: A study in the Journal of the American Medical Association (JAMA) found that

elderly people taking benzodiazepines for anxiety or insomnia were at increased risk for

motor vehicle crashes. Brenda Hemmelgarn, M.N., Samy Suissa, Ph.D., and colleagues

from McGill University and Royal Victoria Hospital, Montreal, Quebec, studied 224,734

drivers aged 67 to 84 years and determined a 45% increased rate of motor vehicle crashes

involving injuries for elderly patients during the first seven days of taking a long-acting

form of benzodiazepine.120

2001: A British study reported an “increase in hostility and aggression may be reported by

patients taking benzodiazepines. The effects range from talkativeness and excitement to

aggressive and antisocial acts.”121

February 2001: British professor C. Heather Ashton reported cases of babybattering,

wife-beating and “grandmother-bashing” could be attributed to people taking

benzodiazepines.122

March 2005: The UK government’s House of Commons (Parliament) Health Committee

released findings of its inquiry into benzodiazepines and reported the side effects “are

now known to include excessive sedation, decreased attention, amnesia and sometimes

intractable dependence. Abrupt cessation can lead to severe withdrawal symptoms,

including convulsions in some patients. Short-term treatment and a long tapering period is

now recommended to limit these risks.”123

January 2008: The Journal of Clinical Nursing published an article entitled, “Falls and

Fall Risk Among Nursing Home Residents,” that concluded, “A higher intake of medicine

was associated with an increase in fractures and thus with more serious consequences of

falls which jeopardize these patients’ safety. Although freedom-restricting actions cannot

eliminate falls totally, our results support the hypothesis that they might be protective when

used selectively together with fewer sedatives, especially benzodiazepines.”124

Warnings and Studies on Specific Anti-anxiety Drugs:

Champix (varenicline in the UK):

December 14, 2007: The British Medicines and Healthcare Products Regulatory Agency

in conjunction with the European Medicines Agency (EMEA) published a warning that

stated: “Doctors are already aware of the risk of using Champix [a benzodiazepine-based

drug, promoted for smoking cessation] in patients who have an underlying mental illness.

They also need to be aware of the possibility that patients who are trying to stop smoking

can develop symptoms of depression, and they should advise their patients accordingly.

Patients who are taking Champix and develop suicidal thoughts should stop their treatment

and contact their doctor immediately.”125

Chantix (varenicline in the U.S.):

November 20, 2007: The FDA issued “Early Communication About an Ongoing Safety

Review Varenicline (marketed as Chantix, a benzodiazepine based drug, promoted for

smoking cessation).” The FDA warned that drug companies had reported incidents of

suicidal thoughts, aggressive and erratic behavior, and drowsiness in patients who had

taken Chantix.126

February 1, 2008: The FDA warned that serious neuropsychiatric symptoms had occurred

in patients taking Chantix. The drug can cause changes in behavior, agitation, depressed

mood, suicidal ideation, and attempted and completed suicide.127

ROHYPNOL (flunitrazepam):

Note: The U.S. has not approved Rohypnol for medical use. It is legally sold in Latin

America and Europe for insomnia and is smuggled into the U.S. from Mexico and South

America.

A 2000 Swedish study of 47 juvenile delinquents found that 40% were acute abusers of

a minor tranquilizer, Rohypnol—known as the “fear reducer” and “date rape” drug—that

enabled them to commit extremely violent crimes. Abusers showed no guilt about their

violent offenses: “When I stabbed him, it felt like putting a knife into butter,” states the

report. “I didn’t feel any emotion when I stabbed him five times,” a teenager reported.128

It is also known as a “club drug,” a general term for a number of illicit drugs, primarily

synthetic, that are most commonly encountered at nightclubs and “raves.” The drugs have

gained popularity primarily due to the false perception that they are not as harmful, nor as

addictive, as mainstream drugs such as cocaine and heroin. The drug chemically induces

amnesia and often causes decreased blood pressure, drowsiness, visual disturbances,

dizziness, confusion, gastrointestinal disturbances, and urinary retention.129

Stilnox (AMBIEN, zolpidem):

Zolpidem is a non-benzodiazepine hypnotic prescribed often for insomnia. It includes

Adormix, Ambien, Edluar, Damixan, Hyprogen, Invelald, Lioran, Nytamel, Sanval,

Stilnoct, Stilnox, Sucedeal, Zoldem, Zolnod and Zolphihexal.

February 21, 2008: The Australian Therapeutic Goods Administration (TGA) imposed a

boxed warning in the product information for medicines containing zolpidem (Stilnox). The

boxed warning stated: “Zolpidem may be associated with potentially dangerous complex

sleep-related behaviors which may include sleep walking, sleep driving and other bizarre

behaviors. Zolpidem is not to be taken with alcohol. Caution is needed with other CNS

[Central Nervous System] depressant drugs. Limit use to four weeks maximum under close

medical supervision.” The TGA said it would carry warnings of possible side effects,

“including rage reactions, worsening insomnia, confusion, agitation, hallucinations and

other forms of unwanted behavior.”130

May 7, 2008: The FDA approved safety labeling revisions to advise of the risks for

abnormal thinking and behavioral changes in patients taking zolpidem and other sedativehypnotic

drugs. Use of sedative-hypnotics in primarily depressed patients has been

linked to worsening depression, including suicidal thoughts and actions and completed

suicide. Behavioral changes include “sleep-driving.” The FDA also warned that rare cases

of angioedema (allergic skin disease) have been reported in patients taking the first or

subsequent doses of sedative-hypnotics. Symptoms can include throat closing, or nausea

and vomiting requiring emergency care. Because airway obstruction can cause death, patients in whom angioedema develops after taking zolpidem should not be “rechallenged

with the drug.”131

XANAX (alprazolam):

December 1990: Dr. John Steinberg, medical director of the Chemical Dependency

Program at the Greater Baltimore Medical Center and president of the Maryland Society of

Addiction Medicine, confirmed that patients taking one Xanax tablet each day for several

weeks could become addicted. Further, after a patient stops taking Xanax, it takes the brain

six to eighteen months to recover. Xanax patients should be warned, he said, that it could

take a long time to get over painful withdrawal symptoms.132

1984: A study of Xanax, “Extreme anger and hostile behavior emerged from eight of the

first 80 patients we treated with alprazolam [Xanax]. The responses consisted of physical

assaults by two patients, behavior potentially dangerous to others by two more, and verbal

outbursts by the remaining four.” The study reported that a woman who had no history of

violence before taking Xanax “erupted with screams on the fourth day of taking alprazolam

treatment, and held a steak knife to her mother’s throat for a few minutes.”133

1985: Another study found that more than half of the Xanax study group experienced

“dyscontrol,” meaning violence or loss of control of aggressive behavior. The violence

included “deep neck cuts…wrist cuts…tried to break own arm…threw chair at child…arm

and head banging…jumped in front of a car.”134

2001: Drug experts said Xanax is more addictive than most illegal drugs, including cocaine

or heroin, and once someone is hooked, getting off it can be a tortuous and even deadly

experience.135

July 2005: The National Center on Addiction and Substance Abuse at Columbia University

issued a report called “Under the Counter: The Diversion and Abuse of C ontrolled

Prescription Drugs in the U.S.” stating that 15 million Americans were getting high on

prescription drugs, painkillers and psychiatric drugs such as Xanax and the stimulants

Ritalin and Adderall. They were abusing these drugs more than cocaine, heroin and

methamphetamines combined. Teens who abused prescription drugs were 12 times likelier

to use heroin, 14 times likelier to use Ecstasy and 21 times likelier to use cocaine, compared to teens that do not abuse such drugs. 136

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

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

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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

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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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(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

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

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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.

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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

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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

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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

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• 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)
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• Tegretol (0)
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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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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;
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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
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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
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39 Sarah Boseley, “Suicide fear from antidepressants,” The Guardian (London), 18 Feb. 2005.
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56 Steve Mitchell, “Analysis: SSRIs’ risk to infants,” United Press International, 6 Feb. 2006.
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58 Maria Bishop, “Use of Antidepressants in Pregnancy Affects Neonatal Outcomes: Presented at AACAP,” Doctor’s Guide, 29 Oct.
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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
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66 “New Warning for Strattera,” FDA Talk Paper, 17 Dec. 2004.
67 “Attention Drug to Get New Warning,” Los Angeles Times, 18 Dec. 2004.
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69 “New Drugs in Pipeline,” Psychiatric News, 21 Dec. 2001.
70 “Lilly to add suicide warning to Strattera,” ABC News, 29 Sept. 2005.
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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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Indication

Cymbalta is indicated for the treatment of major depressive disorder (MDD). The efficacy of Cymbalta was established in four short-term and one maintenance trial in adults.

Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of Cymbalta was established in three short-term and one maintenance trial in adults.

Cymbalta is indicated for the management of diabetic peripheral neuropathic pain and fibromyalgia.
Important Safety Information About Cymbalta

Antidepressants can increase suicidal thoughts and behaviors in children, teens, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Call your doctor right away if you have new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Approved only for adults 18 and over.
What should I talk about with my healthcare provider?

Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, thoughts of suicide, anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call your healthcare provider right away if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of antidepressant treatment or whenever there is a change in dose.
Who should NOT take Cymbalta?

You should not take Cymbalta if:
You have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI)
You have uncontrolled narrow-angle glaucoma (increased eye pressure)
You are taking Mellaril® (thioridazine)

What other important information should I discuss with my healthcare provider?

Before starting Cymbalta, talk with your healthcare provider:
about all of your medical conditions, including kidney or liver problems, glaucoma, diabetes, seizures, or if you have bipolar disorder. Cymbalta may worsen a type of glaucoma or the control of blood sugar in some patients with diabetes about your alcohol use
if you are taking nonprescription or prescription medicines, including those for migraine, to address a possible life-threatening condition
if you are taking NSAID pain relievers, aspirin, or blood thinners. Use with Cymbalta may increase bleeding risk
if you are pregnant, plan to become pregnant during therapy, or are breastfeeding an infant

While taking Cymbalta, talk with your healthcare provider:
if you have itching, right upper belly pain, dark urine, yellow skin/eyes, or unexplained flu-like symptoms, which may be signs of liver problems. Severe liver problems, sometimes fatal, have been reported
if you have high fever, confusion, and stiff muscles to address a possible life-threatening condition
before stopping Cymbalta or changing your dose
if you experience dizziness or fainting upon standing, especially when first starting Cymbalta or when increasing the dose
about your blood pressure. Cymbalta can increase your blood pressure. Your healthcare provider should check your blood pressure prior to and while taking Cymbalta
if you experience headache, weakness, confusion, problems concentrating, memory problems, or feel unsteady while taking Cymbalta which may be signs of low sodium levels
if you develop problems with urine flow

If you have any questions, talk to your healthcare provider before taking Cymbalta.
What are the possible side effects of Cymbalta?

The most common side effect of Cymbalta was nausea. Other common side effects included dry mouth, sleepiness, constipation, decreased appetite, and, increased sweating. This is not a complete list of side effects.
Other safety information about Cymbalta:

Cymbalta may cause sleepiness and dizziness. Until you know how Cymbalta affects you, you should not drive a car or operate hazardous machinery.

Important Safety Information About Cymbalta

Antidepressants can increase suicidal thoughts and behaviors in children, teens, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Call your doctor right away if you have new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Approved only for adults 18 and over.
What should I talk about with my healthcare provider?

Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, thoughts of suicide, anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call your healthcare provider right away if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of antidepressant treatment or whenever there is a change in dose.
Who should NOT take Cymbalta?

You should not take Cymbalta if:
You have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI)
You have uncontrolled narrow-angle glaucoma (increased eye pressure)
You are taking Mellaril® (thioridazine)
What other important information should I discuss with my healthcare provider?

Before starting Cymbalta, talk with your healthcare provider:
about all of your medical conditions, including kidney or liver problems, glaucoma, diabetes, seizures, or if you have bipolar disorder. Cymbalta may worsen a type of glaucoma or the control of blood sugar in some patients with diabetes
about your alcohol use
if you are taking nonprescription or prescription medicines, including those for migraine, to address a possible life-threatening condition
if you are taking NSAID pain relievers, aspirin, or blood thinners. Use with Cymbalta may increase bleeding risk
if you are pregnant, plan to become pregnant during therapy, or are breastfeeding an infant

While taking Cymbalta, talk with your healthcare provider:
if you have itching, right upper belly pain, dark urine, yellow skin/eyes, or unexplained flu-like symptoms, which may be signs of liver problems. Severe liver problems, sometimes fatal, have been reported
if you have high fever, confusion, and stiff muscles to address a possible life-threatening condition
before stopping Cymbalta or changing your dose
if you experience dizziness or fainting upon standing, especially when first starting Cymbalta or when increasing the dose
about your blood pressure. Cymbalta can increase your blood pressure. Your healthcare provider should check your blood pressure prior to and while taking Cymbalta
if you experience headache, weakness, confusion, problems concentrating, memory problems, or feel unsteady while taking Cymbalta which may be signs of low sodium levels
if you develop problems with urine flow

If you have any questions, talk to your healthcare provider before taking Cymbalta.
What are the possible side effects of Cymbalta?

The most common side effect of Cymbalta was nausea. Other common side effects included dry mouth, sleepiness, constipation, decreased appetite, and, increased sweating. This is not a complete list of side effects.
Other safety information about Cymbalta:

Cymbalta may cause sleepiness and dizziness. Until you know how Cymbalta affects you, you should not drive a car or operate hazardous machinery.
Source: http://www.cymbalta.com

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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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