Atypical Antipsychotics - increased mortality in elderly patients with dementia
April 12, 2005
The FDA posted a new health advisory regarding increased risk of death in elderly patients using atypical antipsychotics for "off-label" uses. The following products are asked to update their product information with boxed warnings regarding increased mortality in demented elderly patients using atypical antipsychotics for behavioral disturbances: aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), clozapine (Clozaril), ziprasidone (Geodon), and olanzapine/fluoxetine (Symbyax). Seventeen trials of the first four drugs listed showed an increased rate of death for those elderly patients with dementia, about 1.6 to 1.7 times that of placebo. Although all causes of death were included in this number, the majority were related to cardiac or infectious sources.
Additional information is available at the following links:
- MedWatch Alert:
- Health Professional Information:
April 12, 2005; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.