Since the launch of the drugs, there have been 98 suicides and 188 attempted suicides in Chantix users and 14 suicides and 17 attempted suicides in Zyban users, the agency reported.
Strongest warning on the packaging
Two smoking-cessation medicines, Pfizer Inc.'s smoking-cessation drug Chantix and GlaxoSmithKline’s Zyban which are prescribed to help smokers stop smoking, will now carry "black-box" warnings on the potential risks of psychiatric problems, including depression and suicidal thoughts, the federal agency announced Wednesday.
U.S. health officials said yesterday that they were mandating the black-box warnings, the strictest possible, based on reports of behavioral changes, depressed mood, agitation, hostility and suicidal thoughts and behavior associated with use of the drugs submitted to the agency 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," said Dr. Curt Rosebraugh, director of the FDA's Office of Drug Evaluation II.
Drugs are still an important tool for smokers to quit habit
Despite the black box warning-the agency’s most serious caution, the FDA said consumers and doctors have to balance the risks of the drugs with the substantial benefits of quitting smoking.
"Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
"Stopping smoking is a goal we all want to work towards, and if people need medication to do it they should have access to it. So we don't want to scare people off from trying to use a medication to stop smoking; we just want them to be carefully monitored," Rosebraugh added.
About Chantix and Zyban
Chantix and Zyban are two smoking cessation drugs that are prescribed to help smoker who want to stop their nicotine addiction for good, and start to live a healthier and better quality of life.
Chantix is a nicotine-free, oral tablet which is to be taken twice a day for 12 weeks to help adults quit smoking. This works by cutting the pleasure of smoking and reducing withdrawal symptoms with the help of an active ingredient Varenicline.
GlaxoSmithKline's smoking cessation drug Zyban is also a non-nicotine aid prescribed for smokers to quit the habit. The aid is being taken by over 5 million people worldwide.
Post new comment