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The Progression of Fenfluramine-Associated Valvular Heart Disease Assessed by Echocardiography

Steven T. Mast, MD; James G. Jollis, MD; Thomas Ryan, MD; Kevin J. Anstrom, MS; and Jack L. Crary, MD
[+] Article, Author, and Disclosure Information

From Duke University Medical Center, Durham, North Carolina; and MeritCare Medical Center, Fargo, North Dakota.

Acknowledgments:The authors thank Liz Whirley and Karen Berger for invaluable assistance with this project.

Grant Support:By research grant HL03995-01 from the National Heart, Lung, and Blood Institute, Bethesda, Maryland.

Requests for Single Reprints:James G. Jollis, MD, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715.

Current Author Addresses:Drs. Mast, Jollis, and Ryan and Mr. Anstrom: Duke Clinical Research Institute, Durham, NC 27715.

Dr. Crary: MeritCare Medical Center, 737 Broadway, Fargo ND 58123.

Author Contributions:Conception and design: S.T. Mast, J.G. Jollis, T. Ryan, J.L. Crary.

Analysis and interpretation of the data: S.T. Mast, J.G. Jollis, T. Ryan, J.L. Crary.

Drafting of the article: S.T. Mast, J.G. Jollis, K.J. Anstrom, J.L. Crary.

Critical revision of the article for important intellectual content: S.T. Mast, J.G. Jollis, T. Ryan, K.J. Anstrom, J.L. Crary.

Final approval of the article: S.T. Mast, J.G. Jollis, T. Ryan, K.J. Anstrom, J.L. Crary.

Provision of study materials or patients: J.L. Crary.

Statistical expertise: J.G. Jollis, K.A. Anstrom.

Obtaining of funding: J.G. Jollis.

Administrative, technical, or logistic support: J.G. Jollis, T. Ryan.

Collection and assembly of data: S.T. Mast.

Ann Intern Med. 2001;134(4):261-266. doi:10.7326/0003-4819-134-4-200102200-00008
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In 1997, the first report of significant valvular heart disease occurring in patients exposed to the dietary suppressant fenfluramine was published (1). The investigators described 24 patients from North Dakota and Minnesota who took combination therapy with fenfluramine and phentermine for an average of 11 months and developed clinically significant left- and right-sided valvular regurgitation. In many cases, the mitral valve leaflets, especially the posterior leaflet, appeared restricted and thickened on echocardiography. In 1997, the U.S. Food and Drug Administration described results from five centers that did echocardiography in patients taking fenfluramine and dexfenfluramine and found that nearly one third of exposed patients met their case definition of at least moderate mitral regurgitation or mild aortic regurgitation (2). Furthermore, the prevalence of significant regurgitation was higher in patients who took these drugs for longer than 6 months. As a result, fenfluramine and dexfenfluramine were voluntarily withdrawn from the U.S. market in September 1997.

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Summary for Patients

What Happens to Heart Valve Damage Caused by Diet Drugs after Treatment with the Drug Has Been Stopped?

The summary below is from the full report titled “The Progression of Fenfluramine-Associated Valvular Heart Disease Assessed by Echocardiography.” It is in the 20 February 2001 issue of Annals of Internal Medicine(volume 134, pp 261-266). The authors are ST Mast, JG Jollis, T Ryan, KJ Anstrom, and JL Crary.


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