Pharmaceutical Injuries - Fen Phen

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Fen Phen

Fen Phen, or Pondimin (generic name: fenfluramine) and Redux (generic name: dexfenfluramine) is linked to heart valve disease and Primary Pulmonary Hypertension. Fen Phen was a popular appetite suppressant drug prescribed to people wishing to lose weight.

In 1997 the FDA asked American Home Products to withdraw Pondimin (Fenfluramine) and Redux (Dexfenfluramine) from the market. American Home Products Corp. of Madison, N.J., manufactured fenfluramine under the brand name Pondimin and an American Home Product's subsidiary Wyeth-Ayerst Laboratories, manufactured Dexfenfluramine for Interneuron Pharmaceuticals, which was marketed under the name of Redux. Medical studies have linked Pondimin or Redux to heart valve disease.

The FDA stated that in findings from doctors who evaluated patients that took Fenfluramine and Dexfenfluramine with echocardiograms, that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms. This is a much higher than expected percentage of abnormal test results.

Additionally, a Mayo Clinic study that was published in the New England Journal of Medicine on August 28, 1997 suggested that as high as one-third of a patient sampling of Fen-Phen diet pill users had evidence of heart valve disease. The study reported 24 cases of rare valvular disease in women who took the “fen-phen” combination therapy. FDA alerted medical doctors that it had received nine additional reports of the same type, and requested all health care professionals to report any such cases to the agency’s MedWatch program .

In addition to heart valve disease, the use of fenfluramine and dexfenfluramine has been found to increase the risk of developing Primary Pulmonary Hypertension or (PPH). PPH is a rare disease of that causes the progressive narrowing of the blood vessels of the lungs. Studies estimate that treatment with certain appetite suppressant drugs tends to increase the chances of developing PPH by approximately 25 to 30 percent.

FDA Fen Phen Information & Risks

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