New warning on antipsychotic drugs used to treat older people

FDA Consumer, July-August, 2005

The FDA has issued a public health advisory on the unapproved use of several antipsychotic drugs to treat behavioral disorders in older people.

The drugs, which include Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), Clozaril (clozapine), and Geodon (ziprasidone), are approved only for the treatment of schizophrenia and mania. Clinical studies of these drugs to treat behavioral disorders in older patients with dementia have shown a higher death rate associated with their use, compared with patients receiving an inactive substance (placebo), according to the FDA.

The April 2005 advisory also applies to such antipsychotic drugs as Symbyax (olanzapine and fluoxetine HCI), which is approved for treatment of depressive episodes associated with bipolar disorder.

The FDA is requesting that the manufacturers of the drugs add a boxed warning to their drug labeling describing this risk, and noting that the drugs are not approved for the treatment of behavioral symptoms in older people with dementia. Older people receiving these drugs for this particular treatment should have their treatment reviewed by their health care providers.

The agency also is considering a warning for the labeling of older antipsychotic medications because limited data also suggest a similar increase in the risk of death for these drugs. The review of the data on the older antipsychotic drugs is ongoing.

Visit www.fda.gov/cder/drug/advisory/antipsychotics.htm for additional information concerning the advisory.