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.
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