FDA Removes Warnings of Serious Mental Health Side Effects from Chantix, Zyban Labels

WASHINGTON, D.C. — Based upon its recent review of a large clinical trial, the Food and Drug Administration has determined that the risk of serious side effects on mood, behavior or thinking with smoking cessation drugs Chantix (varenicline) and Zyban (bupropion) is “lower than previously suspected.”

According to a Dec. 16 update to a previous Drug Safety Communication, the FDA is removing the boxed warning regarding serious mental health side effects from the Chantix label, as well as the language describing such side effects seen in patients quitting smoking from the Zyban boxed warning.

The FDA said it is also …