FDA Advisory Panel Votes Against Removing Boxed Warning from Chantix Label

A Food and Drug Administration advisory panel Oct. 16 voted against removing the boxed warning on the risk of serious neuropsychiatric adverse events from the label of Pfizer Inc.'s smoking cessation drug Chantix (varenicline).

The boxed warning highlights the risk of serious mental health events including changes in behavior, depressed mood, hostility and suicidal thoughts when taking Chantix.

At a joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, 11 panel members voted that current the boxed warning should be retained and the agency should wait until the completion of a ...