FDA Drug Safety Communication

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FDA Date: 6/30/09

Wellbutrin SR (bupropion sustained-release) FDA Drug Safety Communication

Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)

FDA has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products. These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.

The same changes to the prescribing information and Medication Guide for patients will also be required for bupropion products (Wellbutrin and generics) that are indicated for the treatment of depression and seasonal affective disorder.

This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.

View the full FDA Drug Safety Communication on FDA.gov