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FDA Warns Antipsychotic Drugs May Be Risky for Elderly
Bridget M. Kuehn
JAMA. 2005;293:2462.
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Treatment with atypical antipsychotic drugs may cause a nearly 2-fold increase in the rate of death in elderly dementia patients, warned the Food and Drug Administration (FDA) in a recent advisory.
Analyses of 17 placebo-controlled studies of four drugs—olanzapine, aripiprazole, risperidone, and quetiapine—have revealed a 4.5% mortality rate among elderly patients with dementia who had been treated for behavioral symptoms with these second-generation antipsychotics compared with a 2.6% mortality rate among patients treated with a placebo, according to the agency. The studies were, on average, 10 weeks in duration and enrolled a combined 5106 patients with dementia. The causes of death varied, although most were related to cardiovascular problems, including heart failure and sudden death or infections such as pneumonia.
The advisory applies to these four drugs, plus two other atypical antipsychotics (clozapine and ziprasidone), which the FDA has approved for the treatment of schizophrenia and mania. . . . [Full Text of this Article]
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