Medical News: FDA Warns of MI, PAD Risk With Varenicline - in Primary Care, Smoking & Tobacco from MedPage Today

Medical News: FDA Warns of MI, PAD Risk With Chantix - in Primary Care, Smoking & Tobacco from MedPage Today

WASHINGTON -- The FDA warned today that smokers with a history of heart attack or stroke who use the smoking cessation drug varenicline (Chantix; Champix in Canada) may increase their risk of a second heart attack or new onset peripheral vascular disease.

The agency said an additional warning will be added to the drug's label and prescribing information describing a small, but measurable increase in the risk of cardiovascular events including nonfatal myocardial infarction, angina, and need for coronary revascularization.

Additionally, the label will warn that use of varenicline may increase the risk for a "new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease" among persons with a history of cardiovascular disease.

In its announcement, the FDA noted that smoking significantly increases the risk of cardiovascular events, so it advised physicians and patients to weigh the known benefits of varenicline treatment "against its potential risks when deciding to use the drug in smokers with cardiovascular disease."