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Diet-Drug Debacle

Alfred F. Parisi, MD
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The Miriam Hospital; Providence, RI 02906 Requests for Reprints: Alfred F. Parisi, MD, Brown University School of Medicine, The Miriam Hospital, 164 Summit Avenue, Providence, RI 02906.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1998;129(11_Part_1):903-905. doi:10.7326/0003-4819-129-11_Part_1-199812010-00013
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One of the realities and frustrations of the practice of clinical pharmacotherapy is the withdrawal of a previously approved medication from the marketplace. Such action engenders anxiety, concern, and disappointment among patients and physicians, as well as the U.S. Food and Drug Administration (FDA) and drug manufacturers. This not-infrequently repeated scenario received great public attention last year when the manufacturers of fenfluramine and its D-isomer, dexfenfluramine, voluntarily removed these agents from the market. Unlike many other pharmaceuticals that were previously recalled, fenfluramine had been on the market for more than two decades (dexfenfluramine was approved in 1996). Both of these medications are serotoninergic agents that are thought to exert their anorectic action through enhanced neurotransmission in the feeding centers of the brain. Fenfluramine was approved in 1973 for short-term monotherapy for obesity; dexfenfluramine was approved as monotherapy for longer-term use with the caveat that its safety beyond 1 year had not been documented. Phentermine, a noradrenergic agent with a different mechanism of action, was approved in 1959-again, for short-term single-drug treatment of obesity. It has frequently been used in combination with dexfenfluramine and, particularly, fenfluramine (a combination known as “fen-phen”).


diet ; fenfluramine

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