FDA warning on antipsychotic drugs

NEWS IN BRIEF — Posted May 2, 2005

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The Food and Drug Administration is asking that a black-box warning be placed on several drugs that are frequently used "off label" to treat behavioral disorders in elderly patients with dementia. The agency issued a public health advisory April 11.

The drugs, which include Zyprexa and Risperdal, were shown to increase the risk of death among elderly patients, primarily due to heart failure or infections, such as pneumonia. These second-generation antipsychotics are approved for treating schizophrenia and were thought to be safer than drugs, such as Haldol, that they replaced.

The FDA said it also is considering adding a similar warning to the label of older antipsychotic medications because the limited data available suggest that they cause a similar increase in mortality.

The agency said it had analyzed 17 placebo-controlled trials performed with olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal) or quetiapine (Seroquel), and 15 of the trials had shown increases in mortality in the drug-treated group compared with the placebo-treated group. The studies had enrolled a total of 5,106 patients.

Note: This item originally appeared at

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