FDA
Alert [
Based
on currently available data, FDA has requested that the package insert for clozapine be revised to include a black box warning
describing this risk and noting that this drug is not approved for this
indication.
Increased
Mortality in Patients with Dementia-Related Psychosis FDA has determined that patients with dementia-related
psychosis treated with atypical (second generation) antipsychotic
medications are at an increased risk of death compared to placebo. Analyses
of seventeen placebo controlled trials that enrolled 5106 elderly patients
with dementia related behavioral disorders revealed a risk of death in the
drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated
patients. Clinical trials were performed with Zyprexa
(olanzapine), Abilify (aripiprazole), Risperdal (risperidone), and Seroquel (quetiapine). Over the course of these trials averaging
about 10 weeks in duration, 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.