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Smoking Cessation Drugs To Get Boxed Warning


Have you tried to quit smoking? Good for you. If you have been using any of the smoking cessation drugs (Chantix, Zyban, Wellbutrin), then the FDA has a warning for you and your doctors.

The FDA has received reports via it’s Adverse Event Reporting System of serious mental health events with the use of these drugs. Their review of these reports suggest an increased risk to the individual taking the drugs. These events reported include changes in behavior, depressed mood, hostility, and suicidal thoughts. As of July 1st, the FDA will require manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs highlighting these risks.

The boxed warning will be placed on Chantix (varenicline), Zyban (bupropion), Wellbutrin (bupropion) and the generic versions of bupropion.

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The FDA states it’s review of the adverse events reported did not identify a clear link between these smoking cessation medications and suicidal events. It is therefore asking manufacturers to conduct a clinical trial to determine how often serious neuropsychiatric symptoms occur in patients using various smoking cessation therapies, including patients who currently have psychiatric disorders.

Smoking remains the leading cause of preventable disease, disability, and death in the United States. I would encourage you to stop smoking. If you and your doctor make the choice to use smoking cessation medications to aid you in stopping, then watch for any unusual changes in mood or behavior after starting these drugs.

Other articles of interest:
Smoking: Become a Quitter
Health Benefits of Halting the Cigarette Habit

FDA Press Release



reports of chantix & suicidal ideation can be seen here: http://www.fdable.com/aers/advanced_query/c00b9d7b425e also here: http://www.fdable.com/analysis/query/9dbdbadab24e/q