FDA Adds Cardiovascular Warning to Chantix Label

by Dr Sam Girgis on June 17, 2011

The United States Food and Drug Administration (FDA) released a drug safety communication on June 16, 2011 to notify the general public about a small but increased risk of heart disease in individuals taking Chantix (varenicline) with a prior history of heart disease.  Chantix is used by millions of people to help quit smoking.  Ironically, smoking is an independent risk factor for the development of coronary artery disease.  Thus, smoking cessation is a one of several ways that someone can lower their risk of heart disease.  Other risk factors that should be controlled include high blood pressure, high cholesterol, and uncontrolled diabetes.  The FDA reviewed a randomized clinical trial of 700 smokers with heart disease that were treated with Chantix or a placebo medication.  During a 12 week treatment period, participants of the study received either Chantix twice daily or a placebo medication.  The results showed that Chantix had a statistically significantly higher 4 week continuous quit rate compare to the placebo medication.  47% of the participants that took Chantix reported abstinence from smoking or other tobacco products while only 14% of the placebo group reported abstinence.  There were some cardiovascular events that were reported in more of the patients taking Chantix compared to the placebo group.  These included angina pectoris, nonfatal myocardial infarction, and need for coronary revascularization.  In addition, there was increased reporting of a new diagnosis of peripheral artery disease or an admission for the treatment of peripheral artery disease by an invasive procedure.  These results show that Chantix is effective in helping patients quit smoking.  The FDA is advising physician to weigh the benefits of Chantix and the help it can provide with smoking cessation with the potential risks of its use in smokers with heart disease.  These added risks are in addition to the previously reported increased risk of suicidal ideation in patients taking Chantix.  The FDA reported that it would be adding this safety information to the Chantix physician labeling.  There are other options for those who want help in the quitting process and these include Zyban and nicotine gum and patches.  Lastly, smokers can try to quit the old fashioned way without any of these added risks… cold turkey!

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