MONDAY, July 25 (HealthDay News) -- The U.S. Food and Drug Administration notified health care professionals and patients that the drug label for varenicline (Chantix) was updated to include information about the effectiveness and safety of the drug when used in patients with chronic obstructive pulmonary disease (COPD) or cardiovascular disease.
Varenicline is approved as an aid in smoking cessation. The FDA updated the warnings and precautions section of the drug label to include the information that the use of varenicline may be associated with a small but elevated risk of certain cardiovascular adverse events in patients who have cardiovascular disease.
The FDA reviewed a randomized, double-blind, placebo-controlled clinical trial of 700 smokers with cardiovascular disease, who were treated with varenicline or placebo, and found certain cardiovascular events occurred more frequently in patients treated with varenicline as compared to those who received placebo. The cardiovascular events included myocardial infarction, angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease. The FDA also reviewed a randomized clinical trial evaluating the efficacy and safety of varenicline in 460 patients with mild-moderate COPD and found the drug to be effective and safe as compared to placebo.
According to the FDA, the agency "is continuing to evaluate the cardiovascular safety of Chantix and is requiring the manufacturer to conduct a large, combined analysis (meta-analysis) of randomized, placebo-controlled trials. FDA will update the public when additional information is available."
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