Results Wire: US FDA Advisory Committee Votes to Retain Boxed Warning for Pfizer’s Chantix – OCT 16, 2014 (PDAC)
On Thursday, October, 16, 2014 the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee weighed in regarding the neuropsychiatric adverse events associated with Pfizer’s Chantix.
A majority, consisting of 11 members, voted to retain the current boxed warning statements and reassess once the ongoing postmarketing randomized controlled trial, designed to capture serious neuropsychiatric adverse events, is completed. Six members voted to modify the language in the boxed warning. One member voted to remove the boxed warning statements regarding risk of serious neuropsychiatric adverse events.