What is the new evidence that prompted withdrawal of fenfluramine and dexfenfluramine?
On July 8, 1997, the Mayo Clinic reported 24 patients developedheart valve diseaseafter taking Pondimin. 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 Pondimin users suggested that there might be an association between Redux use and valve disease.On July 8, 1997, 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. FDA has since received thousands of reports (including the original 24 Mayo cases) of heart valve disease associated mainly with fen-phen. There were also reports of cases of heart valve disease in patients taking only fenfluramine or dexfenfluramine.
