The U.S. Food and Drug Administration said it will immediately require boxed warnings about the risk of serious neuropsychiatric symptoms on the packaging of two popular smoking cessation drugs — varenicline (Chantix) and buproprion (Zyban, Wellbutrin and generics).
U.S. Food and Drug Administration
Reports of behavioral changes, depressed mood, agitation, hostility and suicidal thoughts and behavior associated with use of the drugs have been submitted to the FDA’s adverse event reporting system.
Throughout the marketing history of the drugs, there have been 98 suicides and 188 attempted suicides in varenicline users and 14 suicides and 17 attempted suicides in buproprion users, the agency reported.
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