FDA panel recommends dropping serious warning on Pfizer's Chantix

Pfizer's Chantix was approved about a decade ago, but thousands of reports of mental health problems in users led to the FDA imposing the "black box" warning - the most severe available - in 2009. On Wednesday, four of the 19 panelists voted to update the language in the box warning - of neuropsychiatric risks including suicidal thoughts, hostility and agitation - while five recommended retaining it. The 10 who voted in favor of removal stressed that the benefits of quitting smoking far outweighed the potential severe side-effects of the drug, and that the evidence of causality between Chantix and the side-effects was not clear enough to warrant a black box.