Fen-Phen

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. FDA has received over 100 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. No cases meeting FDA's definition of a case were reported in patients taking phentermine alone.

Additional information received by the FDA raised more concern. Most of the cases previously brought to the FDA's attention were in patients who had symptoms of heart disease. FDA then received reports from five physicians who had performed heart studies (echocardiograms) on patients who had received fen-phen or dexfen-phen and did not have symptoms of heart disease. Of 291 asymptomatic patients screened, about 30 percent had abnormal valve findings, primarily aortic regurgitation. Based on these data, the manufacturers agreed to withdraw the products from the market and FDA recommended that patients stop taking the drugs.

Source: fda.gov

If you or a loved one has been harmed by Fen-Phen, you may want to contact a Fen-Phen attorney for more information.