Incidence Of Cardiovascular Events With Varenicline For Smoking Cessation Post-Acute Coronary Syndrome

In 2011, the FDA and Health Canada informed the public of post-marketing reports of myocardial infarction and stroke in users of varenicline, despite an absence of RCT data or biological rationale supporting increased risk. In December 2012, the FDA revised prescribing information based on the results of a meta-analysis of RCTs in the general population; although rare, cardiovascular (CV) events were numerically higher in the varenicline group. This difference was not statistically significant. Despite an FDA rapid assessment report in March 2013 indicating no difference in risk of CV events between varenicline and bupropion for smoking cessation, there remains concern about the CV safety of varenicline.