FDA Revises Side Effects for Chantix (varenicline) and Zyban (bupropion)

PUBLISHED: Dec 19, 2016
Source: Food and Drug Administration

The US Food and Drug Administration has issued a Drug Safety Communication to alert health care professionals to the removal of the Boxed Warning, FDA’s most prominent warning, for serious mental health side effects from the Chantix drug label.

Based on the FDA’s review of a large clinical trial that they required the drug companies to conduct, the FDA has determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. The language describing the serious mental health side effects seen in patients quitting smoking will also be removed from the Boxed Warning in the Zyban label. The FDA is also updating the existing warning section in both labels that describes the side effects on mood, behavior, or thinking to include the results from the clinical trial.

FDA’s review of the clinical trial results also confirmed that Chantix, Zyban, and nicotine replacement patches were all more effective for helping people quit smoking than was an inactive placebo treatment. These medicines were found to better help people quit smoking regardless of whether or not they had a history of mental illness.

According to the FDA, health care professionals should counsel patients about the benefits of stopping smoking and how they can get help to quit, and discuss the benefits and risks of using medicines to help them quit smoking.

Want to read the full alert and receive alert emails?

Browse Additional Alerts