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# FDA Allows Pfizer to Remove Boxed Warning From Chantix
- URL: https://www.fdaweb.com/fda-allows-pfizer-to-remove-boxed-warning-from-chantix/
- Published: 2016-12-16T12:00:00.000Z
- Updated: 2026-09-14T21:55:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137595

FDA has approved updates to Pfizer’s Chantix (varenicline) labeling, including removal of a boxed warning on serious neuropsychiatric events. The removal was based on data from the EAGLES study, the largest smoking cessation clinical trial in patients without and with a history of psychiatric disorder. 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, a company [release](http://www.pfizer.com/news/press-release/press-release-detail/fda%5Fapproves%5Fremoval%5Fof%5Fboxed%5Fwarning%5Fregarding%5Fserious%5Fneuropsychiatric%5Fevents%5Ffrom%5Fchantix%5Fvarenicline%5Flabeling?ref=fdaweb.com) says.