FDA approves Chantix warning revisions
The removal of the warning regarding neuropsychiatric events and updates to the label were based on the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) smoking cessation clinical trial. This study evaluated Chantix versus bupropion, a nicotine replacement patch, or a placebo in patients with and without psychiatric disorders.
Approximately 8,000 smokers participated in the trial.
“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,” Pfizer Inc. Chief Medical Officer Dr. Freda Lewis-Hall said. “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 health care providers.”
Smoking is responsible for approximately 540,000 preventable deaths in the U.S. annually. Quitting smoking reduces the risk of lung cancer, heart disease, stroke and other tobacco-related diseases.
“While the benefits of quitting are immediate and substantial, few smokers are able to quit on their own and need the help of counseling and smoking cessation therapy,” Massachusetts General Hospital Center for Addiction Medicine Director Dr. A. Eden Evins said. “As health care 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.”
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