Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

The Committees discussed a completed postmarketing-requirement: a randomized, placebo controlled trial of the neuropsychiatric effects of CHANTIX (varenicline), ZYBAN (bupropion), and nicotine replacement therapy, along with relevant published observational studies, to determine whether the findings support changes to product labeling.

A majority of the Committee members, 10 of 19 members, voted that the FDA should remove the boxed warning statements regarding the risk of serious neuropsychiatric (NPS) adverse events (AEs) associated with Chantix.

Five of the 19 members voted that the FDA should keep the boxed warning statements.

Four of 19 members voted that the FDA should modify the language of boxed warning statements.