Dementia drugs linked to death, FDA says

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Antipsychotic medications for dementia could cause premature deaths, federal drug regulators said this week.

The Food and Drug Administration now requires that manufacturers of the medicines put black-box warnings on the labels of all the drugs. The widely prescribed drugs include Zyprexa and Symbyax from Eli Lilly, Risperdal from Johnson & Johnson, Seroquel from AstraZeneca, Abilify from Bristol-Myers Squibb, Clozaril from Novartis and Geodon from Pfizer.

While the drugs are believed to be safer than the older class of medicines for psychosis, studies now suggest that the newer drugs are only slightly less likely to cause tardive dyskinesia, and there are other concerns. Tardive dyskinesia is an affliction that can involve uncontrollable trembling and tics.

The FDA said that it had analyzed the results of 17 placebo-controlled trials involving the drugs. The agency found that elderly patients with dementia who were given the pills were 1.6 to 1.7 times as likely to die as those given placebos. The causes of death varied, although most died of heart-related problems such as heart failure or infections like pneumonia, the drug agency said.