EU updates label of Champix (varenicline) for nicotine addiction- Pfizer

Pfizer announced that the European Summary of Product Characteristics (SmPC) and Package Leaflet for Champix (varenicline) have been updated to include safety and efficacy data from the EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) trial. As part of the update, the black triangle symbol, which indicated that additional safety monitoring for Champix in the EU was required, has been removed.

EAGLES is a post-authorization safety study/post-marketing requirement study, which was conducted in 16 countries and designed to evaluate the neuropsychiatric safety of Chantix/Champix and bupropion versus placebo and nicotine replacement therapy patch (NRT) in patients with and without a history of psychiatric disorder. The outcomes of the EAGLES trial were recently published in The Lancet. The Champix EU label update was implemented following the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

Comment:The authors of The Lancet article concluded that no significant increase in serious neuropsychiatric adverse events with Chantix/Champix relative to placebo or nicotine patch. Smokers treated with Chantix/Champix had significantly higher quit rates than those treated with bupropion, nicotine patch or placebo.