Anti-Smoking Drugs Get FDA 'Black-Box' Warning
July 2 -- WEDNESDAY, July 1 (HealthDay News) -- Two drugs prescribed to help people quit smoking, Chantix and Zyban, will now carry "black-box" warnings on the potential risks of psychiatric problems, including depression and suicidal thoughts, U.S. health officials said Wednesday.
The U.S. Food and Drug Administration said it was mandating the black-box warnings, the strictest possible, based on reports to the agency of these side effects and on a review of clinical trials and scientific literature.
"We are requiring the manufacturers of the smoking-cessation drugs Chantix and Zyban to add a new boxed warning highlighting the risk of serious mental health symptoms with use of these products," Dr. Curt Rosebraugh, director of the FDA's Office of Drug Evaluation II, said during a Wednesday teleconference.
The agency's review found that some people who used Chantix (varenicline) and Zyban (bupropion) experienced unusual changes in behavior, became depressed, or had their depression worsen and had thoughts of suicide or dying, the FDA said.
Rosebraugh said there were reports of 98 suicides and 188 suicide attempts involving Chantix, and 14 suicides and 17 attempts reported with Zyban.
For many users, the problems started soon after they began taking the drugs and ended when they stopped taking them. Some users, however, continued to have symptoms even after stopping the drugs. In a few cases, the problems started after the drugs were stopped, Rosebraugh said.
People taking these drugs who develop any of these symptoms should be monitored until their symptoms clear up, even if symptoms develop after stopping these drugs, Rosebraugh added.
The drugs don't contain nicotine, and some of the symptoms may be caused by nicotine withdrawal. People who stop smoking can suffer from depression, anxiety, irritability, restlessness, and sleep disturbances, the FDA noted.
Some patients who were using the drugs experienced the side effects while they were still smoking, the agency said.
