Rapid Assessment of Cardiovascular Risk Among Users of Smoking Cessation Drugs Within the US Food and Drug Administration's Mini-Sentinel Program | Cardiology | JAMA Internal Medicine | JAMA Network
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Research Letter
May 13, 2013

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

Author Affiliations

Author Affiliations: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts (Drs Toh, Baker, Brown, and Platt); and Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (Dr Kornegay).

JAMA Intern Med. 2013;173(9):817-819. doi:10.1001/jamainternmed.2013.3004

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.

Mini-Sentinel is part of the FDA's Sentinel Initiative, a national system under development for monitoring medical product safety.3-5 The program has created a distributed network of electronic health care databases with more than 125 million lives and 350 million person-years of longitudinal observation time.