Practice Guideline Briefs

FDA Warns Against Off-Label Use of Antipsychotic Drugs



FREE PREVIEW Log in or buy this issue to read the full article. AAFP members and paid subscribers get free access to all articles. Subscribe now.


FREE PREVIEW Subscribe or buy this issue. AAFP members and paid subscribers get free access to all articles.

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//www.fda.gov/cder/drug/infopage/antipsychotics/default.htm.


Copyright © 2005 by the American Academy of Family Physicians.
This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact afpserv@aafp.org for copyright questions and/or permission requests.

Want to use this article elsewhere? Get Permissions


Article Tools

  • Print page
  • Share this page
  • AFP CME Quiz

Information From Industry

Navigate this Article