TABLE 1.

The FDA Black Box Warnings Regarding Atypical Antipsychotics in Dementia

“Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. These drugs are not approved for the treatment of patients with dementia-related psychosis.”

“Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients…in trials of DRUG X* in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with DRUG X compared to patients treated with placebo. DRUG X is not approved for the treatment of patients with dementia-related psychosis.”

^*Applies to risperidone, olanzapine, and aripirazole.