Customize your JAMA Network experience by selecting one or more topics from the list below.
Toh S, Baker MA, Brown JS, Kornegay C, Platt R, Mini-Sentinel Investigators FT. Rapid Assessment of Cardiovascular Risk Among Users of Smoking Cessation Drugs Within the US Food and Drug Administration's Mini-Sentinel Program. JAMA Intern Med. 2013;173(9):817–819. doi:10.1001/jamainternmed.2013.3004
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).
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.
Create a personal account or sign in to: