Harvard Mental Health Letter

In Brief: More evidence that varenicline harms the heart

Varenicline (Chantix) is one of the most common drugs prescribed for people who want to stop smoking. But evidence is growing that it may harm the heart.

In June 2011, the FDA warned people with heart disease that varenicline could slightly raise risk of heart attacks and other cardiac events, and asked the drug's manufacturer to add a warning label to that effect. In July 2011, a meta-analysis that reviewed results from 14 randomized controlled studies provided information about how to better understand the risks and benefits of varenicline.

Researchers at Johns Hopkins University School of Medicine and Wake Forest University School of Medicine conducted the meta-analysis. They found that smokers assigned to varenicline were 72% more likely to experience a heart attack, stroke, abnormal heartbeat (arrhythmia), or sudden cardiac death than smokers assigned to placebo. In absolute terms, 52 of 4,908 participants assigned to varenicline had a cardiac event while taking the drug, compared with 27 of 3,308 assigned to placebo.

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