FDA Panels Support Removal of Black Box Label for Pfizer’s Chantix

Two FDA advisory committees backed the removal of a black box label for Pfizer’s smoking cessation drug Chantix, citing the therapy’s risk-benefit ratio.

A post-marketing study of the drug demonstrated no increased risk of serious neuropsychiatric events linked to Chantix, leaving most of committee members convinced that the product should no longer carry a black box label.

A few committee members found the study inadequately powered to address adverse neuropsychiatric events such as suicidality and voted in favor of keeping the black box label.