FDA approves removal of boxed label warning from Pfizer’s Chantix

BY Brian Berk

NEW YORK — The U.S. Food and Drug Administration approved removal of the boxed label warning regarding serious neuropsychiatric events from Pfizer’s Chantix (varenicline).

According to Pfizer, the approval of 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.

Chantix was approved by the FDA in May 2006 as a prescription medication that, along with support, helps adults 18 and over stop smoking. It is approved in more than 100 countries and has been prescribed to over 20 million patients worldwide, including more than 11 million in the U.S.

“For millions who smoke, stopping smoking is one of the most important steps they can take to improve their health, and Pfizer is committed to helping smokers in their quit journey,” said Freda Lewis-Hall, M.D., DFAPA, chief medical officer and EVP, Pfizer Inc. “We are pleased with the FDA’s decision to update the CHANTIX labeling based on EAGLES — the largest clinical trial of smoking cessation medications — and we expect this new information may further facilitate an informed discussion about quitting with CHANTIX between smokers and healthcare providers.”


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