Fen Phen Heart Valve Damage Lawsuit

The Food and Drug Administration (FDA ) issued a recall of fenfluramine and dexfenfluramine in 1997 after the diet drugs were linked with heart valve damage and Primary Pulmonary Hypertension (PPH).

The FDA reported that, although Fenfluramine and phentermine were approved in the 1950s as individual agents for short-term use in the medical management of obesity, the use of Fen Phen products concomitantly had never been approved in the United States. However, the combination of the two products, i.e., Fen phen, was prescribed "off label" by many American health care practitioners as an appetite suppressant.

The agency encouraged medical professionals to report any heart valve irregularities found in patients that had taken Fen phen to the FDA.

FDA Announces Withdrawal of Fenfluramine and Dexfenfluramine

After receiving new evidence associating significant adverse side effects with fenfluramine and dexfenfluramine (Redux), the FDA 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 agreed to voluntarily withdraw their drugs.

In the US alone, between 6 million and 7 million people took fen phen and in 1996 there were 18,000,000 prescriptions written for the diet drug. Approximately 50,000 lawsuits have been filed by Fen-Phen users against the drugs' manufacturers, and in 2002 the manufacturers of the drug settled a nationwide lawsuit for $3.75 billion.