FDA Drops Black Box Warning on Pfizer's Anti-Smoking Drug Chantix
December 19, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Shares of Pfizer are on the rise this morning after the company announced Friday the U.S. Food and Drug Administration removed the black box warning label regarding neuropsychiatric events, such as thoughts of suicide or hostility, from its anti-smoking drug, Chantix.
Pfizer has been fighting the black box warning label almost since the drug was approved.
Chantix, known chemically as varenicline, was approved by the FDA in 2006 for use as an anti-smoking medication. In clinical trials, use of Chantix increased the likelihood of people quitting smoking and not smoking for as long as one year. In 2009 and 2011, the FDA also issued warnings about possible serious neuropsychiatric side effects with Chantix, including suicidal thoughts, hostility and agitation. Those warnings are highlighted on the Chantix label and surrounded by a black box, which is reserved for the most serious of warnings by the FDA. The warning label includes information about several studies that investigated the risk of neuropsychiatric side effects on mood, behavior, or thinking occurring with Chantix.
The FDA removed the black box warning label after Pfizer announced results from its EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) trial largest smoking cessation clinical trial in patients without and with a history of psychiatric disorder. The EAGLES study was jointly funded by GlaxoSmithKline , which markets its own anti-smoking drug, Zyban. The study also provided for the removal of a similar black box warning from Zyban, U.S. News and World Report said on Friday.
The EAGLES study included patients with and without a history of psychiatric disorders. In the cohort of patients with past psychiatric issues, Pfizer said there were more adverse events reported compared to the cohort of patients without a history of psychiatric problems.
While the warning labels were removed, the two drugs will still list paranoia, depression, hallucinations, homicidal ideation, aggression, hostility, agitation, anxiety and other neuropsychiatric problems on the boxes. But, gone will be the bold black box around the warning, which is reserved for the most severe warnings.
Smoking is the leading preventable cause of death in the United States, responsible for roughly 540,000 deaths each year. Pfizer said it hopes the removal of the black box label will “further facilitate an informed discussion about quitting with CHANTIX between smokers and healthcare providers.”
“As healthcare providers work on the front lines to help people who are struggling to quit smoking, this new labeling provides clinically relevant information on the safety and efficacy of CHANTIX to help them and their patients make informed decisions about smoking cessation treatment,” Dr. A. Eden Evins, director, Massachusetts General Hospital Center for Addiction Medicine, said in a statement released by Pfizer.