The Food and Drug Administration (FDA) has updated the prescribing information label on the smoking-cessation drug varenicline (Chantix) to warn that the drug may increase the risk of certain cardiac events in people with underlying cardiovascular disease.
The change is based on findings from a clinical trial of 700 smokers who have cardiovascular disease, according to a safety announcement issued by the FDA on June 16. Trial participants were randomly assigned to receive varenicline or a placebo for 12 weeks and were then followed for an additional 40 weeks without treatment. Although cardiac events “were infrequent overall,” the agency noted that “certain events, including heart attack, were reported more frequently in patients treated with Chantix than in patients treated with placebo.”
Other cardiac events included small increased risks of chest pain, the need for coronary revascularization procedures, and peripheral vascular disease. The two most common events in patients taking varenicline were nonfatal heart attacks (7 versus 3 among those taking the placebo) and coronary revascularization procedures (8 versus 3). Five of the seven patients who required a revascularization procedure were from the same group of participants who had had a nonfatal heart attack.
Physicians should be aware of these risks and discuss the benefits and potential risks of varenicline with their patients who have heart disease, the agency stated in the announcement. In July 2009, the FDA added a “black box” warning about the increased risks of neuropsychiatric symptoms associated with their use to the labels of varenicline and another smoking cessation drug, bupropion (Zyban).
NCI Cancer Bulletin for June 28, 2011 - National Cancer Institute
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