What is the FDA warning about for stop-smoking drugs Chantix and Zyban?”
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
Smokers looking to quit may have another hurdle to jump in breaking their habit. The U.S. Food and Drug Administration (FDA) today issued an urgent warning to doctors and smokers that several popular products used to help people quit smoking may have serious side effects. Pfizer, the maker of Chantix (the popular name for varenicline), along with Zyban, Wellbutrin and other such generic products (using bupropion) are being told by the FDA that they must add new warnings and medication guidelines to the products that alert healthcare professionals and Stop Smoking Aids Pose a Danger: FDA Issues Warning Date: July 1, 2009 patients of the risk of serious neuropsychiatric symptoms in patients using the products. This comes as a serious blow to the millions of people internationally who depend on smoking cessation drugs and mechanisms to quit smoking. According to the American Cancer Society smoking and other types of tobacco use is responsible for nearly 20 percent of the deaths in the Uni
July 1, 2009 — The FDA warns that bizarre behavior — including suicide — is seen in people taking the stop-smoking drugs Chantix and Zyban. Both drugs now will carry “black box” labels warning that people taking the drugs should be closely watched for signs of suicidal thoughts, depression, hostility, or other changes in behavior. “We want people to use these drugs carefully and pay attention,” Robert J. Temple, MD, director of the FDA’s office of medical policy, said at a news conference. “Stopping smoking is a goal we all want to work toward.
