FDA Committees Weigh In on Boxed Warning for Chantix

At a joint meeting of the Food and Drug Administration (FDA)’s Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee, a majority vote recommended the removal of the boxed warning regarding serious neuropsychiatric adverse events from the Chantix (varenicline; Pfizer) labeling.

The Committees reviewed data from EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study), which evaluated theneuropsychiatric safety of Chantix. Pfizer’s proposed supplemental New Drug Application (sNDA) requested the removal of the boxed warning while keeping the Warnings and Precautions section regarding serious neuropsychiatric events occurring in patients attempting to quit smoking with updates on EAGLES data. 

EAGLES, a randomized, blinded, placebo-controlled study, was the first to compare the safety and efficacy of all three currently approved smoking cessation therapies in over 8,000 smokers with and without a history of psychiatric disorders. The composite primary endpoint consisted of 16 components reflecting the type of events reported in the Chantix postmarketing experience and those found in the labeling. Full results can be found in the April issue of The Lancet. 

“We are pleased with the Committees’ recommendation to remove the boxed warning and believe this is an important step toward updating the Chantix labeling to more accurately reflect its neuropsychiatric safety profile and help patients and prescribers make informed decisions about treatment options,” said Freda Lewis-Hall, MD, DFAPA, Chief Medical Officer and EVP, Pfizer Inc.

Chantix, an alpha4-beta2 nicotinic acetylcholine receptor partial agonist, was initially approved by the FDA in May 2006 to aid adults aged ≥18 years in smoking cessation along with support. The Advisory Committees serve to provide recommendations to the FDA but the FDA makes the final labeling decisions.

For more information call (800) 438-1985 or visit Chantix.com.