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Mesothelioma Information Booklet

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Fen-Phen


The Drugs - A Brief History

The makers of Pondimin (fenfluramine) and Redux (dexfenfluramine) voluntarily withdrew the drugs from the market at the request of the Food and Drug Administration (FDA) over health concerns. When Pondimin or Redux is taken in combination with Phentermine, heart valve damage may occur.

Pondimin and Redux were originally approved for short term use only by the FDA in the treatment of obesity. However, the combination commonly called fen-phen had never been approved. Wyeth-Ayerst Laboratories, the manufacturer of Pondimin (fenfluramine) and distributor of Redux (dexfenfluramine), decided to recall the two diet drugs amid reports from the Mayo Clinic indicating resultant heart defects.

 It has been known for years that Pondimin and Redux can cause primary pulmonary hypertension (PPH), a fatal heart condition. Yet, the manufacturers down-played the likelihood that people could contract PPH.

In the summer of 1997, physicians at the Mayo Clinic reported that the drugs also cause heart valve defects. In particular, the aortic and mitral valves may be impaired, thus causing regurgitation of blood into the ventricle and left atrium respectively. If this condition is serious enough, it may require lifelong monitoring, medication, or valve surgery.


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