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.
Kuehn BM. FDA Warns Antipsychotic Drugs May Be Risky for Elderly. JAMA. 2005;293(20):2462. doi:10.1001/jama.293.20.2462