FDA expands antipsychotic drug warning

Older, conventional antipsychotic medications can increase the risk of death in some elderly patients, the U.S. Food and Drug Administration warned on Monday.

The agency called for the drugs to include a strong "black box" warning about the risk, seen in older patients being treated for dementia-related psychosis.

Older antipsychotic include Pfizer Inc's Navane, Johnson & Johnson's Haldol, and Endo Pharmaceutical Holdings Inc's Moban, among others, according to a database on the FDA's Web site.

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It was not immediately clear which drugs are still on the market, and representatives for the companies could not be immediately reached for comment. Some, such as GlaxoSmithKline Plc's Thorazine, are no longer sold.

FDA officials issued a similar warning for other, newer antipsychotic drugs in 2005. Those drugs — which include Abilify, from Bristol-Myers Squibb Co and Otsuka Pharmaceutical Group, and Zyprexa, from Eli Lilly and Co — already carry a boxed warning about such risk.

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"The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis," the FDA said in a statement.

Neither the older or newer medications are approved to treat forgetfulness and other symptoms of dementia, the FDA said. But while such use is not approved by the agency, doctors are allowed by law to prescribe medications as they see fit.

Most antipsychotic drugs are aimed at treating symptoms of schizophrenia, a disorder of the brain that can trigger unusual thoughts and behavior as well as speech trouble and memory problems.