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Health Agencies Update
January 23/30, 2013

Varenicline Safety Notice

JAMA. 2013;309(4):333. doi:10.1001/jama.2013.16

A new US Food and Drug Administration (FDA) safety notice suggests a slightly higher occurrence of adverse cardiovascular events is associated with the smoking cessation drug varenicline compared with placebo (http://tinyurl.com/ajrev5j).

After a 2011 clinical trial found an increased risk of serious cardiovascular events among patients with cardiovascular disease using varenicline, the drug's label was revised and the FDA warned the public of the risk (http://tinyurl.com/72zwenq). The agency also required the drug's manufacturer to conduct a meta-analysis of clinical trials of varenicline to compare the risk of major adverse cardiac events (cardiovascular-related death, nonfatal myocardial infarction, and nonfatal stroke) among patients taking the drug and those taking placebo.