Fenfluramine and dexfenfluramine are appetite suppressants. Prior to being removed from the market in 1997, fenfluramine, marketed under the tradename Pondimin was commonly prescribed in combination with another appetite suppressant, phentermine. The combination was known by the popular name fen-phen (or phen-fen, as some prefer). Dexfenfluramine, a chemical cousin of fenfluramine (its dex-isomer), was marketed under the tradename Redux. Fenfluramine was approved by the FDA for single-drug, short-term use (somewhat vaguely described as "a few weeks" in the approved labeling) as an appetite suppressant in 1973; dexfenfluramine was approved for longer-term use in 1996. The FDA noted at that time that the safety of dexenfluramine beyond 1 year of use had not been established by clinical trials.

Both fenfluramine and dexfenfluramine are thought to act by affecting the metabolism of the neurotransmitter serotonin in the brain. Serotonin and Eating Disorders, Medical Sciences Bulletin Oct 1994, http:// pharminfo.com/pubs/msb/seroton.html. It has been reported that the histopathologic features of fenfluramine- and dexfenfluramine-associated valvulopathy are similar to those observed in carcinoid-induced valvular disease, a serotonin-related syndrome. Cardiac Valvulopathy Associated with Exposure to Fenfluramine or Dexfenfluramine: U.S. Department of Health and Human Services Interim Public Health Recommendations, November 1997, CDC, MMWR 1997 Nov 14;46(45); see also, Robiolio PA, et al., Carcinoid heart disease: Correlation of high serotonin levels with valvular abnormalities detected by cardiac catheterization and echocardiography

In 1997, the United States Food and Drug Administration requested the voluntary withdrawal of fenfluramine and dexfenfluramine from the market, after receiving a number of reports of heart valve disease (valvulopathy) apparently caused by these drugs. In a press release dated September 15, 1997, the FDA reported that it took this action based on new findings from doctors who had evaluated patients taking these two drugs with echocardiograms, a special procedure that can test the functioning of heart valves. These findings indicated that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms. Michael A. Friedman, M.D., the Lead Deputy Commissioner of the FDA, was quoted in the FDA press release: "These findings call for prompt action. The data we have obtained indicate that fenfluramine, and the chemically closely related dexfenfluramine, present an unacceptable risk at this time... ."

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