Chantix Increases Risk of Major Cardiovascular Events, FDA Warns

Washington, DCPeople taking the smoking cessation drug Chantix (varenicline) may have a higher risk of suffering major adverse cardiovascular events, according to information issued by the Food and Drug Administration this week. The results support earlier findings.

The data are from a large, combined analysis (meta-analysis) of clinical trials that compared patients who received Chantix to patients who received a placebo (an inactive treatment). The results show a higher occurrence of major adverse cardiovascular events (a combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke) in patients using Chantix compared to placebo.

The FDA noted that the increased incidence of cardiovascular events was not statistically significant, which means it is uncertain whether the excess risk for the Chantix group was due to the drug or due to chance. However, these results confirm those of an earlier study which also prompted the FDA to issue a warning regarding a potential link between the use of Chantix and heart problems in patients who have cardiovascular disease.

According to the FDA's drug safety communication issued June 16, 2011, a clinical trial involving 700 smokers with cardiovascular disease found that those treated with Chantix were at a higher risk of cardiovascular adverse events than patients who were treated with a placebo. Those cardiovascular events included a risk of heart attack, angina pectoris and peripheral vascular disease.

Chantix has also been linked to an increased risk of violent outbursts and suicide attempts. Concerns about neuropsychiatric symptoms resulted in the FDA requiring a change to the Chantix label, to include a black box warning about Chantix side effects and the risk of depression, aggression and attempted suicide.