FDA: Chantix Linked to Heart Attack in People With Heart Disease

Small Increased Risk Seen in Chantix Users With Cardiovascular Disease

By Denise Mann
WebMD Health News

Reviewed by Louise Chang, MD

June 16, 2011 -- The smoking cessation drug Chantix (varenicline) may result in a small increased risk for heart attacks and other heart problems among people with cardiovascular disease, according to the FDA.

The FDA reviewed data on 700 smokers with cardiovascular disease who were treated with either Chantix or placebo. Those individuals who took Chantix were more likely to quit smoking for at least one year, but the drug did slightly increase their risk for developing heart problems including heart attacks, when compared with their counterparts who took placebo. Information on this potential risk will now be added to Chantix's label and included in a patient medication guide.

The FDA will continue to monitor for risk of heart problems in Chantix users and is now requiring that Chantix manufacturer Pfizer analyzes all of the available data to get a better handle on the potential heart risks associated with the use of this drug.

In a statement, Pfizer pointed out that the overall number of cardiovascular events seen among Chantix users with heart disease was low.

"As stated by the FDA, patients should contact their healthcare professional if they experience new or worsening symptoms of cardiovascular disease," the statement reads. "Smoking is a major risk factor for cardiovascular disease, which can lead to heart attack, stroke, and peripheral arterial disease. The health benefits of quitting smoking are immediate and substantial."

Bruce Darrow, MD, PhD, an assistant professor of cardiology/medicine with the Mount Sinai School of Medicine in New York City, says in a statement that "it's too early to conclude that Chantix shouldn't be given to any patients with existing heart disease and many of the benefits of stopping smoking could be expected to be apparent beyond the one year period reported here."

He adds that "even though these problems occurred in a small number of patients, it's enough to suggest that doctors consider other ways of getting their patients to quit smoking before prescribing Chantix."

Chantix has also been linked to emotional or mood changes including agitation, depression, and suicidal thoughts.

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SOURCES: Pfizer: "Statement Regarding the FDA's Drug Safety Communication on Chantix."FDA: "FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease."Bruce Darrow, MD, PhD, assistant professor, cardiology/medicine, Mount Sinai School of Medicine, New York. ©2011 WebMD, LLC. All Rights Reserved.