FDA Removes Boxed Warning for Chantix and Zyban

By Marie Rosenthal

The FDA lifted the boxed warning concerning serious neuropsychiatric side effects for varenicline (Chantix, Pfizer) and bupropion (Zyban, GlaxoSmithKline).
Based on an FDA review of a large clinical trial that the agency required the manufacturers to conduct, the FDA determined the risk for serious side effects on mood, behavior or thoughts with the smoking cessation aids is lower than previously suspected. The risk for these mental health side effects is still present,