In 2005, based on a review of 17 placebo-controlled trials of second-generation antipsychotics (APs) (olanzapine, aripiprazole, risperidone, and quetiapine fumarate), the US Food and Drug Administration (FDA) suggested that the use of atypical APs carries a 1.6- to 1.7-times higher incidence of mortality in elderly, demented people.1 However, the purported increased deaths could not be attributed to specific causes, and cardiac problems (heart failure or sudden death) and infections (mostly pneumonia) were considered to be the largest contributors. In addition to issuing a public health advisory, the FDA henceforth required manufacturers of all atypical APs to include a black box warning to their labeling indicating that these agents (1) are not approved for treatment of psychosis in elderly patients with dementia and (2) carry an increased mortality risk. In 2008, the FDA extended the warning to first-generation APs, concluding that “elderly patients with dementia-related psychosis treated with conventional or atypical antipsychotic drugs are at an increased risk of death.”2
Baron MS. Antipsychotics and Increased Mortality: Are We Sure? JAMA Neurol. 2016;73(5):502–504. doi:10.1001/jamaneurol.2016.0213
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