FDA Orders Warning Label on Older Antipsychotics

By Steven Reinberg
HealthDay Reporter
Tuesday, June 17, 2008; 3:00 AM

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MONDAY, June 16 (HealthDay News) -- The U.S. Food and Drug Administration is cautioning physicians that certain types of antipsychotic drugs can boost the death risk of seniors with dementia.

Doctors sometimes use antipsychotics to help treat behavioral problems in demented patients.

But from now on these older, so-called "conventional" antipsychotics -- which include drugs such as thorazine and prolixin -- will carry a new black box warning alerting physicians of the danger, FDA officials announced Monday.

"We issued letters to all the manufacturers of antipsychotic drugs, both conventional and atypical, requiring them to update their labeling with new language for a box warning about an increased risk of death in elderly patients with dementia," Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products at the Center for Drug Evaluation and Research, said during an afternoon teleconference.

This is a new warning for conventional antipsychotics, but it is not new for another class of the medications, called atypical antipsychotics. Back in 2005, the FDA ordered warning labeling for those medications, which include newer drugs such as Zyprexa and Risperdal. That labeling warned of a higher risk for heart attack and pneumonia for elderly patients with dementia who received atypical antipsychotics.

This new black box warning for older, conventional antipsychotics is one of the first uses by the agency of the Food and Drug Administration Amendments Act of 2007, which gives the FDA authority to mandate drug warnings, something they could only request before.

According to Laughren, the FDA based its 2005 decision on a review of studies comparing their use to a placebo. At the time, a lack of evidence prevented the agency from extending the warning to conventional antipsychotics, Laughren said.

However, since then, observational studies have appeared that indicate that conventional antipsychotics carry the same risk, he said. "The data we have for observational studies are not ideal, so we struggled with this decision, but in the end decided that the data were strong enough to extend the warning to all drugs in this class," he said.