Briefing Summary: US FDA Posts Advisory Committee Materials For a Review of the Neuropsychiatric Adverse Events Associated With Pfizer’s Chantix – OCT 16, 2014 (PDAC-DSRM)
The US FDA has posted details, including company and FDA Briefing Materials, for the Thursday, October 16, 2014 joint meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSRM). The joint committee will discuss safety data from observational studies and a meta-analysis of randomized controlled clinical trials that have been conducted since the original signal of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate tablets, NDA 21928, Pfizer, Inc.) emerged. The committees will also discuss whether any action needs to be taken with regard to how this risk is described in product labeling.