FDA Adds Strong Warnings To Anti-Smoking Drug Labels

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"The Food and Drug Administration announced (Wednesday) that it is requiring the smoking-cessation drugs Chantix and Zyban to carry the strongest type of safety warning possible to alert patients that the medications can cause serious mental health problems, including depression and suicide," the Washington Post reports (Stein, 7/1).

"About 100 suicides in patients taking Chantix have been reported to the FDA since 2006, said Curtis Rosebraugh, an FDA official. By comparison, there have been 14 reports of suicide in patients taking Zyban," the Wall Street Journal reports. "Both companies say there is no evidence that their drugs actually cause suicides or mood swings. And along with the FDA, they both note that smokers trying to quit often experience depression, anger and other psychiatric side effects." The FDA also stressed that the warnings aren't meant to advise smokers not to use the drugs (Mundy and Favole, 7/2).

This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.

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