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Medical News and Perspectives
July 23 2008

FDA: Antipsychotics Risky for Elderly

JAMA. 2008;300(4):379-380. doi:10.1001/jama.300.4.379

The US Food and Drug Administration (FDA) is warning physicians that using conventional antipsychotic drugs to treat elderly patients with dementia may increase the risk of death in these patients. In 2005, the agency warned of similar risks associated with newer atypical antipsychotic drugs.

Under new authority granted to the agency by the Food and Drug Administration Amendments Act of 2007, the agency is requiring manufacturers of conventional antipsychotics (which include prochlorperazine, haloperidol, loxapine, thioridazine, molindone, thiothixene, pimozide, fluphenazine, trifluoperazine, chlorpromazine, and perphenazine) to add a boxed warning to the labels of these drugs notifying physicians that using conventional antipsychotics to treat behavioral problems in elderly patients with dementia is associated with an increased risk of death. Previously, the agency could only request and negotiate for such a change.

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