FDA Warns of Health Risks with Off-label Antipsychotics

Ken Rankin
Published Online: Wednesday, June 1, 2005

Newly discovered health risks for seniors taking certain "atypical antipsychotic drugs" for off-label indications have prompted the FDA to alert pharmacists and other health care providers to the problem.

The drugs-which include aripiprazole, olanzapine, clozapine, risperidone, and ziprasidone-are approved for the treatment of schizophrenia and mania. FDA officials, however, said that new research suggests that, when these products are prescribed off-label to treat behavioral disorders in elderly patients with dementia, a higher risk of death may result. Agency officials have raised the same concerns about a combination olanzapine and fluoxetine HCl formulation (Symbyax), a drug approved for the treatment of bipolar disorder.

In addition to alerting pharmacists to these problems, FDA officials have asked the manufacturers to place new boxed warnings on their drug labeling. The officials also are urging patients who have been taking the drugs for dementia or other off-label behavioral symptoms to have their therapy reviewed.

Mr. Rankin is a freelance medical writer.

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