Chanitx (Varenicline): Risk of Certain Cardiovascular Adverse Events

Drug Alerts , News / October 2, 2016

The FDA is informing the public about the results of a large, combined analysis (meta-analysis) of clinical trials that compared patients who received the smoking cessation drug Chantix (varenicline) to patients who received a placebo. A higher occurrence of major adverse cardiovascular events (a combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke) was observed in patients using Chantix compared to placebo. These events were uncommon in both the Chantix and placebo groups, and the increased risk 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.

Chantix is a prescription medicine that aids in quitting smoking that works by blocking the effects of nicotine on the brain.

Healthcare professionals are advised to weigh the risks of using Chantix against the benefits of its use. It is important to note that smoking is a major risk factor for cardiovascular disease, and Chantix is effective in helping patients quit smoking and abstain from it for as long as one year.

[10th July, 2011]: The FDA notified healthcare professionals and patients that the Prescribing Information for Chantix (varenicline) will be updated to include information that use of varenicline may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section and the patient Medication Guide.

The FDA notified healthcare professionals and patients that the Prescribing Information for Chantix (varenicline) will be updated to include information that use of varenicline may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section and the patient Medication Guide.

Varenicline, the active ingredient in Chantix, is used to treat smoking addiction. It does so by stimulating nicotine receptors more weakly than nicotine does – it is a nicotine receptor partial agonist. Varenicline both reduces cravings for cigarettes and decreases their pleasurable effects.

The FDA reviewed a randomized, double-blind, placebo-controlled clinical trial of 700 smokers with cardiovascular disease who were treated with either Chantix or placebo. Overall, cardiovascular events were infrequent; however, certain events were reported more frequently in those treated with Chantix compared to those with placebo. These events included heart attack, angina pectoris, nonfatal myocardial infarction, coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease.

The FDA is continuing to evaluate the cardiovascular safety of Chantix and is requiring the manufacturer to conduct a large, combined analysis (meta-analysis) of randomized, placebo-controlled trials. The public will be further updated when more information is available.

Healthcare professionals should keep in mind that smoking is an independent and major risk factor for cardiovascular disease, and that smoking cessation is of particular importance in this patient population. The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease.

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