U.S. Food and Drug Administration Warning on Antipsychotic Drugs

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Published as a public service by Citizens Commission on Human Rights

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U.S. Food and Drug Administration Warning on Antipsychotic Drugs Citizens Commission on Human Rights (CCHR) has campaigned against the indiscriminate psychiatric drugging of seniors with dangerous mind-altering drugs. The U.S. Food and Drug Administration (FDA) has finally recognized these dangers: •

On 11 April 2005, the U.S. FDA issued a Public Health Advisory regarding the use of antipsychotic drugs in elderly patients with dementia, citing they can cause an increase in death rates. It applies to the newer antipsychotics such as Zyprexa, Abilify, Risperdal and Seroquel.

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In September 2005, Dr. Jeffrey Lieberman of Columbia University released a federally funded study in the New England Journal of Medicine which found that 74% of the patients in the study discontinued antipsychotic medication before the end of their treatment due to inefficacy, intolerable side effects or other reasons.

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FDA Public Health Advisory, 11 April 2005 “Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances”

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FDA Public Health Advisory Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances The Food and Drug Administration has determined that the treatment of behavioral disorders in elderly patients with dementia with atypical (second generation) antipsychotic medications is associated with increased mortality. Of a total of seventeen placebo controlled trials performed with olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), or quetiapine (Seroquel) in elderly demented patients with behavioral disorders, fifteen showed numerical increases in mortality in the drug-treated group compared to the placebo-treated patients. These studies enrolled a total of 5106 patients, and several analyses have demonstrated an approximately 1.6-1.7 fold increase in mortality in these studies. Examination of the specific causes of these deaths revealed that most were either due to heart related events (e.g., heart failure, sudden death) or infections (mostly pneumonia). The atypical antipsychotics fall into three drug classes based on their chemical structure. Because the increase in mortality was seen with atypical antipsychotic medications in all three chemical classes, the Agency has concluded that the effect is probably related to the common pharmacologic effects of all atypical antipsychotic medications, including those that have not been systematically studied in the dementia population. In addition to the drugs that were studied, the atypical antipsychotic medications include clozapine (Clozaril) and ziprasidone (Geodon). All of tvhe atypical antipsychotics are approved for the treatment of schizophrenia. None, however, is approved for the treatment of behavioral disorders in patients with dementia. Because of these findings, the Agency will ask the manufacturers of these drugs to include a Boxed Warning in their labeling describing this risk and noting that these drugs are not approved for this indication. Symbyax, a combination product containing olanzapine and fluoxetine, approved for the treatment of depressive episodes associated with bipolar disorder, will also be included in the request. The Agency is also considering adding a similar warning to the labeling for older antipsychotic medications because the limited data available suggest a similar increase in mortality for these drugs. Back to Top

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Date created: April 11, 2005 CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page FDA/Center for Drug Evaluation and Research

New England Journal of Medicine, 22 September 2005 “Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia”

new england journal of medicine The

established in 1812

september 22 , 2005

vol. 353

no. 12

Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia Jeffrey A. Lieberman, M.D., T. Scott Stroup, M.D., M.P.H., Joseph P. McEvoy, M.D., Marvin S. Swartz, M.D., Robert A. Rosenheck, M.D., Diana O. Perkins, M.D., M.P.H., Richard S.E. Keefe, Ph.D., Sonia M. Davis, Dr.P.H., Clarence E. Davis, Ph.D., Barry D. Lebowitz, Ph.D., Joanne Severe, M.S., and John K. Hsiao, M.D., for the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators*

abstract background

The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared with that of older agents has been incompletely addressed, though newer agents are currently used far more commonly. We compared a first-generation antipsychotic, perphenazine, with several newer drugs in a double-blind study. methods

A total of 1493 patients with schizophrenia were recruited at 57 U.S. sites and randomly assigned to receive olanzapine (7.5 to 30 mg per day), perphenazine (8 to 32 mg per day), quetiapine (200 to 800 mg per day), or risperidone (1.5 to 6.0 mg per day) for up to 18 months. Ziprasidone (40 to 160 mg per day) was included after its approval by the Food and Drug Administration. The primary aim was to delineate differences in the overall effectiveness of these five treatments. results

Overall, 74 percent of patients discontinued the study medication before 18 months (1061 of the 1432 patients who received at least one dose): 64 percent of those assigned to olanzapine, 75 percent of those assigned to perphenazine, 82 percent of those assigned to quetiapine, 74 percent of those assigned to risperidone, and 79 percent of those assigned to ziprasidone. The time to the discontinuation of treatment for any cause was significantly longer in the olanzapine group than in the quetiapine (P