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The smoking cessation aid varenicline (Chantix, Pfizer) may increase the risk of cardiovascular events in adults with cardiovascular disease, according to a recent FDA safety announcement .
The announcement follows the results of a meta-analysis of 15 Pfizer-sponsored, randomized double-blind, placebo-controlled clinical trials that included 7,002 patients, which was conducted to assess the occurrence and timing of major adverse cardiovascular events.
Researchers found that, within 30 days of treatment, patients taking varenicline were slightly more likely than patients taking placebo to experience a major adverse event, reported as a combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke (varenicline, 0.31% [13/4190]; placebo, 0.21% [6/2812]). FDA notes that the events were uncommon in both groups, and the increased risk was not statistically significant; however multiple data analyses consistently demonstrated a higher occurrence of these events in patients taking varenicline.
FDA reports that the Warnings and Precautions section of the Chantix label has been updated to include the results of the new data.
"It is important to note that smoking is a major risk factor for cardiovascular disease, and Chantix is effective in helping patients to quit smoking and abstain from it for as long as one year. The health benefits of quitting smoking are immediate and substantial," FDA notes. But, the organization advises healthcare professionals to weigh risks of treatment against the benefits for each patient.