FDA approves removal of boxed warning regarding serious neuropsychiatric events for Chantix(varenicline) a treatment for smoking cessation.- Pfizer

Pfizer announced that the FDA approved updates to the Chantix (varenicline) labeling, including removal of the boxed warning regarding serious neuropsychiatric events. The removal of the boxed warning is based on the outcomes of EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study), the largest smoking cessation clinical trial in patients without and with a history of psychiatric disorder, and is consistent with the recent recommendation of the FDA Psychopharmacologic Drugs and Drug Safety and Risk Management Advisory Committees. Additional labeling revisions based on EAGLES include updates to the corresponding warning regarding neuropsychiatric safety and the addition of information on the superior efficacy of Chantix compared to bupropion or nicotine patch.

Comment:The European Summary of Product Characteristics (SmPC) and Package Leaflet for Champix (varenicline) were updated in May 2016 to include safety and efficacy data from the EAGLES trial. As part of the update, the black triangle symbol, which indicated that additional safety monitoring for Champix in the EU was required, was removed.