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Fen-Phen and Redux -- Withdrawn From Market

Jun 30, 2008
The diet drugs Fen-Phen (fenfluramine and phentermine), Pondimin (fenfluramine), and Redux (dexfenfluramine) aid in weight loss by altering the serotonin levels in the brain to suppress feelings of hunger.

During the 1990s, doctors began to prescribe these drugs in combination to increase the weight loss effect. Studies have demonstrated serious potential health risks associated with the use of these drugs. These findings were so serious that the Food and Drug Administration (FDA) withdrew Fen-Phen and Redux from the market in 1997.

Problems associated with the use of these diet drugs include:

* serious heart murmurs,

* heart valve leaks,

* thickening of the heart valves, and

* heart valve regurgitation, which is a build-up of a plaque-like substance on the heart valves.

A 1997 report from the Mayo Clinic found heart valve dysfunction in 30% of Fen-Phen users who were tested. Fen-Phen also causes Primary Pulmonary Hypertension. Lawsuits previously filed state that some manufacturers and distributors were aware of the health risks associated with these drugs and failed to adequately warn of such risks.

Primary Pulmonary Hypertension or PPH is a rare but serious condition affecting only the arteries in the lungs. It is a progressive condition and may eventually be fatal. The condition begins when tiny arteries in the lungs become narrow or blocked, causing increased resistance to blood flow in the lungs, which then raises pressure within the pulmonary arteries.

As the pressure builds, the right ventricle of the heart must work harder to pump blood through the lungs, eventually causing the heart muscle to weaken and sometimes to fail completely. There is presently no cure for PPH, but drug treatments can help lessen symptoms and improve quality of life for many people.

The FDA, along with the Centers for Disease Control and the National Institutes of Health, recommend that anyone who has ever taken either Redux or Fen-Phen alone or with other diet drug medications, should see their doctor immediately for a physical examination to determine if any heart or lung damage has occurred -- even if no symptoms are apparent.

Fen-Phen and Redux Withdrawn from Market

On September 15, 1997, at the request of the US Food and Drug Administration, American Home Products withdrew Fen-Phen and Redux from the market. This followed reports that heart-valve abnormalities were found in 30% of Fen-Phen users who were given diagnostic echocardiograms at the Mayo Clinic. Additional studies also indicated that Fen-Phen caused the potentially fatal lung disease, Primary Pulmonary Hypertension (PPH), in some patients taking the drugs.

Studies have estimated that using Fen-Phen increases a person's chances of developing PPH by approximately 30 percent. Some medical experts contend that there is a potential latency of ten or more years between the last ingestion of Fen-Phen and the development of symptoms.

Fen-Phen and Redux Class Action

The occurrence of heart valve-related health problems associated with the use of Fen-Phen and Redux resulted in a National Class Action Settlement with American Home Products Corp. (AHP), now known as Wyeth, the manufacturer of these diet drugs. The Settlement received final Judicial Approval on January 3, 2002, triggering a number of deadlines.

If you ingested Fen-Phen, Pondimin or Redux, you are automatically a member of the Settlement unless you filed the required paper work to "opt-out" or withdraw. In order to be eligible for certain benefits, you must first register and you must have an echocardiogram (a non-invasive ultrasound of the heart). Individuals who have registered and who meet the requirements for "Matrix" level benefits for heart valve damage and related health problems may be eligible to receive between $7,389 and $1,485,000 in benefits depending on the extent of their injuries.

It is also important to note that the Settlement does not cover or provide benefits to persons diagnosed with PPH. These individuals can proceed with individual lawsuits against Wyeth if they meet the criteria for PPH, as defined in the Settlement program.
About the Author
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