BioCentury
ARTICLE | Clinical News

Chantix varenicline regulatory update

October 27, 2014 7:00 AM UTC

A joint meeting of FDA's Psychopharmacologic Drugs Advisory and Drug Safety and Risk Management Advisory committees voted to retain boxed warning statements on Pfizer's Chantix varenicline for smoking cessation and reassess the statements once an ongoing postmarketing trial is completed. Six of the members voted to modify the language in the boxed warning, and 1 voted for removing the warning statement regarding risk of serious neuropsychiatric adverse events. In 3Q15, Pfizer plans to report data from the randomized controlled postmarketing trial, which is designed to capture serious neuropsychiatric adverse events. In 2011, researchers at the Institute for Safe Medication Practices and colleagues reported data from an analysis of FDA's Adverse Event Reporting System (AERS) showing that Chantix was associated with a significantly increased risk of suicidal/self-injurious behavior and depression vs. other smoking-cessation products (see BioCentury, Nov. 7, 2011). ...