FDA approves Chantix label updates
The updates include removing the boxed warning that is based on the findings of the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES).
The EAGLES clinical trial is the largest smoking study in patients with and without a history of psychiatric disorder; its removal is in-line with the FDA Psychopharmacologic Drugs and Drug Safety and Risk Management Advisory Committee’s recommendation.
“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 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.”
Other revisions to the Chantix label include updated warnings on neuropsychiatric safety and the superior effectiveness of the drug being added.
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