FDA committees recommend removal of black box warning from Chantix

Two FDA advisory committees voted to remove a boxed warning about serious neuropsychiatric adverse events on Chantix labeling, according to a press release from the manufacturer.

After reviewing data from EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study), the Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee recommended that the FDA remove the warning from the labeling for Chantix (varenicline, Pfizer).

As detailed in the release, Pfizer conducted EAGLES along with GlaxoSmithKline in consultation with the FDA and the European Medicines Agency. The randomized, blinded, placebo-controlled trial evaluated the safety and efficacy of three smoking cessation therapies in 8,000 smokers with and without a history of psychiatric disorders.

Based off of the data from EAGLES, Pfizer submitted a supplemental New Drug Application to update the labeling on Chantix.

The FDA had previously announced the addition of a black box warning on Chantix in 2009, which highlighted the risk of serious mental health events that included changes in behavior, hostility, depressed mood and suicidal thoughts.

“The totality of available scientific evidence, including the outcomes of EAGLES, supports the safety and efficacy of Chantix, and we look forward to the FDA’s decision on the Chantix labeling,” Freda Lewis-Hall, MD, DFAPA, chief medical officer and executive vice president of Pfizer Inc., said in the release. “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.”