FDA Alerts Healthcare Professionals of Black Box Warning for Chantix and Wellbutrin/Zyban

July 1, 2009 - The FDA alerted healthcare providers today that the manufacturers of varenicline (Chantix) and bupropion (Zyban, Wellbutrin and generics) must add new "Black Box" warnings highlighting the risk of serious neuropsychiatric symptoms in patients using these products. Symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.

The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease. Some of these cases may have been confounded by symptoms typically seen in people who have stopped smoking and are experiencing withdrawal from nicotine.

Healthcare professionals should advise patients to stop taking varenicline or bupropion and contact a healthcare provider immediately 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. If varenicline or bupropion is stopped due to neuropsychiatric symptoms, patients should be monitored until the symptoms resolve.

The possible risks of serious adverse events occurring while using varenicline or bupropion should always be weighed against the significant health benefits of quitting smoking.