Fen–Phen & Redux Removed From the Market
Fen –Phen Introduction
Fen-Phen, a combination of the drugs phentermine and fenfluramine helps to reduce weight. Fen –Phen was removed from the market when it was found that thirty percent of the patients consuming it suffered from unusual echocardiograms. Use of Fen – Phen has been associated with several cardiac problems like heart valve thickenening, heart murmurs, primary pulmonary hypertension, heart valve regurgitation, heart valve leaks and even death. More than 50,000 patients taking Fen- Phen filed a lawsuit against the manufacturers.
Dietary supplement drugs like Fen-Phen (fenfluramine and phentermine), Redux (dexfenfluramine) and Pondimin (fenfluramine) reduce weight. These drugs work by altering the serotonin levels in the brain to curb the feeling of hunger. It was during the 1990s that doctors prescribed all these drugs in combination to increase the effects of weight loss. Studies have established that the use of these drugs is dangerous for the health. The results of these studies were so serious that the Food and Drug Administration decided to remove Fen – Phen and Redux from the market in 1997.
Illness linked with the use of dietary pills including Fen – Phen:
- Heart valve leaks
- Heart valve regurgitation
- Serious heart murmurs
- Thickening of the heart valves
According to a study conducted by Mayo Clinic in 1997, thirty percent of the patients using Fen-Phen suffered from heart valve dysfunction. Additionally, Fen – Phen user also developed Primary Pulmonary Hypertension (PPH).
Primary Pulmonary Hypertension occurs rarely, however, it is a severe condition affecting the arteries in the lungs. It is continuous and may even become fatal. The small arteries in the lungs are blocked, thus reducing the blood flow to the lungs in this disease. This in turn increases the pressure within the pulmonary arteries. As the pressure increases, right ventricle of the heart works harder to pump the blood through lungs. This leads to the weakening of the muscles of the heart, which at times fails completely. Currently, PPH is incurable.
FDA, along with National Institute of Health and Center for Disease and Control asked the patients to discontinue with the use of Fen – Phen.
Removal of Fen – Phen and Redux from the Market
On September 15, 1997, the U.S. Food and Drug Administration asked American Home Products to remove Redux and Fen – Phen from the market. According to the Mayo Clinic, there were reports to establish that the thirty percent of the patients using Fen – Phen suffered from heart-valve abnormalities. Additionally reports also indicated that the patients taking Fen – Phen suffered from a fatal lung disease called Primary Pulmonary Hypertension (PPH).
Several studies have determined that the patients using Fen – Phen are at an increased risk of developing Primary Pulmonary Hypertension.
Due to the increased risk of health problems related with the use of Fen – Phen a National Class Action Settlement, was filed with the manufacturer of diet drugs, American Home Products Corp. (AHP), also known as Wyeth. After failing to meet the no. of deadlines, this settlement got the final judicial approval on January 3, 2002. Patients who used Fen – Phen, Redux or Pondimin automatically become the member of this settlement, until unless they file the forms to withdraw. In order to receive some benefits, a patient must get himself registered and have an echocardiogram diagnostics. One important thing is that the patients suffering from PPH are not included in this settlement.
Due to certain terms, a patient has to file a lawsuit within a specific period in order to receive compensation.