Fen-Phen

On September 15, at the request of the Food and Drug Administration, Wyeth-Ayerst Laboratories and Interneuron Pharmaceuticals, which manufactured and marketed fenfluramine under the brand name Pondimin and dexfenfluramine under the brand name Redux, voluntarily withdrew these products from the market. The withdrawal was based on initial echocardiographic findings in five surveys indicating that approximately 30 percent of patients in these surveys who took these drugs had valvular abnormalities, even though most had no symptoms.

Anyone who has taken fenfluramine or dexfenfluramine for any period of time, either alone or with another drug or drugs, should see their doctor for a medical history and physical
examination to determine whether there are signs or symptoms of heart or lung disease.

Anyone who has taken these drugs for any period of time, either alone or with another drug or drugs, who has signs or symptoms of heart or lung disease, such as a new heart murmur or shortness of breath, should have an echocardiogram performed.

An echocardiogram should be strongly considered for any patient who has taken these drugs, either alone or with another drug or drugs -- regardless of whether they have signs and symptoms of the heart or lung diseases -- BEFORE having any invasive procedure for which the American Heart Association recommends antibiotic prophylactic treatment to prevent the development of bacterial endocarditis. This will provide an accurate determination of whether or not the person needs the antibiotic treatment.