Friday, June 17, 2011 (Last Updated: 06/20/2011)
FRIDAY, June 17 (HealthDay News) -- The U.S. Food and Drug Administration has warned consumers and health care professionals that varenicline (Chantix) may be associated with a small but increased risk of cardiovascular adverse events in individuals with cardiovascular disease.
Varenicline is considered a smoking cessation aid and has been on the market since 2006. The new warning is based on the FDA's review of data from a study that involved 700 smokers with cardiovascular disease who were undergoing treatment with varenicline or placebo. The data revealed a small but statistically significant increased risk of angina pectoris, non-fatal 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 in individuals taking the drug.
The FDA recommends that individuals undergoing treatment with varenicline should contact their health care provider if they experience new or worsening symptoms of cardiovascular disease. The FDA is continuing to evaluate the cardiovascular safety of varenicline and has requested that Pfizer, the manufacturer of the drug, conduct a large meta-analysis of previous randomized, placebo-controlled trials involving the drug. The FDA will provide an update to consumers and health care professionals when additional data becomes available.
According to the FDA, "health care professionals should be aware that smoking is an independent and major risk factor for cardiovascular disease, and smoking cessation is of particular importance in this patient population. The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease."
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