July 01, 2009
Additional warnings for varenicline and bupropionThe FDA has notified healthcare professionals and patients that it has required manufacturers of varenicline (Chantix, from Pfizer) and bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zyban, from GlaxoSmithKline) to add new Boxed Warnings to the product labeling and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms. These 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 received by the FDA, including those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and behavior in patients with no history of psychiatric disease. Patients should be advised to stop taking varenicline or bupropion and to contact their healthcare professional immediately if they experience agitation, depressed mood, any changes in behavior that are not typical to nicotine withdrawal, or if they experience suicidal thoughts or behavior.
Chantix and Zyban are indicated as smoking cessation aids. Wellbutrin and Wellbutrin SR are indicated for the treatment of depression. Wellbutrin XL is indicated for the treatment of depression and seasonal affective disorder.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170090.htm.