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What is the evidence that prompted withdrawal of fenfluramine and dexfenfluramine?

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What is the evidence that prompted withdrawal of fenfluramine and dexfenfluramine?

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On July 8, 1997, the Mayo Clinic reported 24 patients developed heart valve disease after taking fen-phen. In five patients who underwent valve replacement surgery, the diseased valves were found to have distinctive features similar to those seen in carcinoid syndrome. The cluster of unusual cases of valve disease in fen-phen users suggested that there might be an association between fen-phen use and valve disease. On July 8, FDA issued a Public Health Advisory that described the Mayo findings. The Mayo findings were reported in the August 28 issue of the New England Journal of Medicine, along with an FDA letter to the editor describing additional cases. The FDA has received over 100 reports (including the original 24 Mayo cases) of heart disease associated mainly with fen-phen. There were also reports of heart valve disease in patients taking only fenfluramine or dexfenfluramine. Within the past several weeks, additional information received by the FDA has raised more concern. Most of

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