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