Suicide Warnings for Two Anti-Smoking Drugs

Everyone knows the dangers of smoking. Main government agencies as well as non-profits work on efforts to try to reduce smoking and stop as many people as possible from smoking. However, what is much less known are the unfortunate side effects that may accompany the use of two smoking cessation prescription drugs.

Many people seek to terminate smoking through the use of either varenicline (Chantix) and bupropion (Zyban and generics). While the FDA strongly supports stopping smoking, it has issued strong words of caution for people using these medications. It seeks not to scare people away from using the medications, but wants them to be more careful.

The FDA has recently required that the manufacturers of Chantix and Zyban place what are known as “black box warnings” on the prescribing information for both Chantix and Zyban. Black box warnings are the FDA’s most serious caution. The reason for the black box warnings is that the FDA has concluded that patients taking Chantix and Zyban should be watched closely for signs of serious mental illness associated with the use of these drugs. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170090.htm. Suicidal events, as the FDA calls them, are the primary concern the FDA has expressed.

The FDA recommends that healthcare professionals advise patients that if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or, if they experience suicidal thoughts or behavior, to stop taking these drugs and to contact a healthcare provider immediately

The question of course is whether the drugs are associated with the mental problems, or if, because they are experiencing nicotine withdrawal, patients are more prone to have these problems.

What does this mean? Should you take the drugs? Anyone taking these drugs should talk with their doctor. Taking the drugs to help stop smoking probably remains a very good idea, however, it now is clear that anyone taking the drugs should be closely monitored for signs of mental distress.