Fen-Phen Combo Finished in FDA Finale

WASHINGTON, D.C.- On August 22, 1997, MedicineNet published a Doctor's View entitled Fen-Phen Heart Hazard, a report from the Mayo Clinic which identified diseased heart valves in 24 women treated with fenfluramine-phentermine. None of the women had a history of heart disease. The women had symptoms suggesting heart abnormalities or a heart murmur. According to the report, "there appeared to be an association between these features and fenfluramine-phentermine therapy."

The following is the news release from the U.S. Food and Drug Administration:


The Food and Drug Administration, acting on new evidence about significant side-effects associated with fenfluramine and dexfenfluramine, has asked the manufacturers to voluntarily withdraw both treatments for obesity from the market. Dexfenfluramine is manufactured for Interneuron Pharmaceuticals and marketed under the name of Redux by Wyeth-Ayerst Laboratories, a subsidiary of American Home Products Corp. of Madison, N.J., which also manufactures and markets fenfluramine under the brand name Pondimin. Both companies have agreed to voluntarily withdraw their drugs. The FDA is not requesting the withdrawal of phentermine, the third widely used medication for obesity.

The action is based on new findings from doctors who have evaluated patients taking these two drugs with echocardiograms, a special procedure that can test the functioning of heart valves. These findings indicate 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.