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Withdrawn From The Market: Redux And Fen-Phen

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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. Another severe side effect of Fen-Phen is PPH. 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.

The rare and serious condition known as primary pulmonary hypertension (PPH) affects the arteries within 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.

The heart muscle weakens over time, eventually leading to complete failure, as the heart is forced to pump blood through the lungs and cause the right ventricle to work harder as the pressure builds. 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Fen-Phen and Redux Withdrawn from Market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. It has been suggested by medical professionals that the last dose of Fen-Phen having been digested may still be a risk for nearly ten years following.

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.

Those who have not opted-out or withdrawn from the settlement and who have consumed one of the three controversial weight loss supplements will be automatically apart of the settlement. Individuals must register as well as have a non-invasive ultrasound of the heart, also known as echocardiogram. Those who have previously met the requirements for Matrix level benefits of the heart valve damage have the potential to receive monetary compensation that may near $1.4 million.

Individuals with PPH are not covered by the settlement. These individuals can proceed with individual lawsuits against Wyeth if they meet the criteria for PPH, as defined in the Settlement program.
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