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Medical News & Perspectives
May 25, 2005

FDA Warns Antipsychotic Drugs May Be Risky for Elderly

JAMA. 2005;293(20):2462. doi:10.1001/jama.293.20.2462

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.