Federal drug regulators warned Wednesday that patients taking two popular stop-smoking drugs should be watched closely for signs of serious mental illness, as reported suicides among the drugs’ users mount.
But officials emphasized that patients should not be scared away from taking the smoking-cessation medicines, Chantix, made by Pfizer, and Zyban, made by GlaxoSmithKline.
“Stopping smoking is a goal we should all be working towards,” said Dr. Curt Rosebraugh, director of a drug evaluation office at the F.D.A. “We don’t want to scare people off from trying a medication that could help them achieve this goal. You should just be careful.”
The F.D.A. required Pfizer and Glaxo to place so-called black box warnings — the agency’s most serious caution — on the prescribing information for both drugs. Both companies will be required to conduct clinical trials to assess the mental health risks associated with the drugs’ uses.
Wednesday, July 1, 2009
