FDA Adds Strong Warnings To Anti-Smoking Drug Labels

"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 is part of Kaiser Health News' Daily Report - a summary of health policy coverage from more than 300 news organizations. The full summary of the day's news can be found here and you can sign up for e-mail subscriptions to the Daily Report here. In addition, our staff of reporters and correspondents file original stories each day, which you can find on our home page.