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Research Letters |

Rapid Assessment of Cardiovascular Risk Among Users of Smoking Cessation Drugs Within the US Food and Drug Administration's Mini-Sentinel Program

Sengwee Toh, ScD; Meghan A. Baker, MD, ScD; Jeffrey S. Brown, PhD; Cynthia Kornegay, PhD; Richard Platt, MD, MS; for the Mini-Sentinel Investigators
JAMA Intern Med. 2013;173(9):817-819. doi:10.1001/jamainternmed.2013.3004.
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In June 2011, the US Food and Drug Administration (FDA) issued a Drug Safety Communication indicating that varenicline tartrate, a drug prescribed for smoking cessation, may increase the risk of certain cardiovascular events in individuals with cardiovascular disease.1 The finding was based on the FDA's review of a randomized placebo-controlled trial of 714 smokers.2 In July 2011, the FDA requested that the Mini-Sentinel program perform a rapid safety assessment of the drug.

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