Saturday, July 19, 2008

FDA Extends Black-Box Warning to All Antipsychotics

New studies and label warnings about the risks of all antipsychotics have not made clinical decisions any easier for physicians, patients, and caregivers.

Three years after the Food and Drug Administration (FDA) instituted a black-box warning for all second-generation antipsychotic (SGA) medications about increased risk of death in elderly dementia patients, a similar warning is being added to the labels of first-generation antipsychotics (FGAs) such as haloperidol and perphenazine.

The FDA announced its decision in mid-June after reviewing two epidemiological studies, both conducted in Canada, that were published in 2007. The two studies found mortality rates in elderly patients taking FGAs to be comparable to or higher than the rates in patients taking SGAs.

In a study by Sebastian Schneeweiss, M.D., and colleagues, the mortality hazard ratio in the FGA-treated elderly patients was 1.47 times that of SGA-treated patients within 180 days after starting the antipsychotic prescription. Included in this study were more than 37,000 people in British Columbia aged 65 and older who were started on antipsychotic medications. About one-third of these patients received FGA prescriptions, and the rest were given the newer SGAs. The study was published in the February 2007 Canadian Medical Association Journal.


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