FDA committees recommend removing boxed warning on Pfizer's Chantix

US pharma giant Pfizer (NYSE: PFE) looks set to have the boxed warning removed on its quit smoking product Chantix (varenicline) in the USA.

The removal of the warning was recommended at a joint meeting of the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee on Wednesday.

The committees recommended by a majority vote to do away with the warning regarding serious neuropsychiatric adverse events, although the role of the committees is only to provide recommendations to the FDA, with the agency making the final labeling decisions.