Practice Guideline Briefs

FDA Warns Against Off-Label Use of Antipsychotic Drugs


Am Fam Physician. 2005 Jun 1;71(11):2205.

The U.S. Food and Drug Administration (FDA) has released a warning to physicians and patients that off-label use of certain drugs called “atypical antipsychotics” could be dangerous to older patients with dementia. Included in the advisory are antipsychotics such as aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), clozapine (Clozaril), and ziprasidone (Geodon). Currently, these drugs are approved to treat schizophrenia and mania. However, clinical studies have found that older patients with dementia who received an antipsychotic regimen had a mortality rate 1.6 to 1.7 times higher than patients who received placebo. In these studies, most deaths were heart related or from infection.

The FDA has requested that manufacturers include a warning on the labels of antipsychotic medications describing the risk of off-label use to older patients with dementia. Patients who are taking an antipsychotic to treat a behavioral disorder associated with dementia should consult their physician about continued use.

Additional information regarding this advisory or the specific medications included in the warning is available on the FDA Web site at:http//



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