FDA advisory committees recommend removing Chantix boxed warning

SILVER SPRING,  Md. — The Food and Drug Administration’s advisory committees on psychopharmacologic drugs and drug safety risk management held a recommended Wednesday that the boxed warning accompanying Pfizer’s smoking cessation drug Chantix be removed. 

 

Currently, the drug comes with a boxed warning regarding serious neuropsychiatric adverse events, and the recommendation to remove it comes after the completion of an Evaluating Adverse Events in Global Smoking Cessation Study (EAGLES) evaluating its safety. Pfizer submitted the results to the FDA earlier this year, suggesting the boxed warning be removed while leaving in place a warnings and precautions section with information about potential serious neuropsychiatric events that also features the EAGLES data. 

 

“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,” Pfizer EVP and chief medical officer Dr. Freda Lewis-Hall said. “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.”