Name: Fen Phen
Generic: Fenfluramine and dexfenfluramine
Manufacturer: Wyeth-Ayerst Laboratories
Date approved: Redux (dexfenfluramine) approved April 1996
Status: Withdrawn from market
Approved uses: Weight loss
Off-Label uses: N/A
• Heart Murmurs
• Heart Valve Leaks
• Heart Valve Thickening
• Heart Valve Regurgitation
• Primary Pulmonary Hypertension
Related topics: Unsafe Drugs, Ephedra
Phen Fen Side Effects
Fen-Phen, also known as Phen Fen, is a cocktail of the drugs fenfluramine and phentermine used to aid weight loss. Fenfluramine and phentermine had been approved for separate, short-term use for about 20 years when the FDA approved Redux or dexfenfluramine in 1996. Fen-Phen was withdrawn from the market after if was found that about 30 percent of users had abnormal echocardiograms. Fen-Phen has been linked to serious cardiac problems, including heart murmurs, heart valve leaks, heart valve thickening, heart valve regurgitation, primary pulmonary hypertension and sometimes death. More than 50,000 lawsuits have been filed by Fen-Phen users against the drugs manufacturers.
Dangerous Diet Pills: The Side Effects of Fen-Phen
As Americans, we value efficiency and we place considerable emphasis on the necessity of beauty and health. In our fast-paced world, a healthy diet and lifestyle can sometimes take a back seat to the pressures and demands that career and family place on individuals. As such, dozens of diet drugs and dietary supplements have flooded the market in the last few decades. Unfortunately, diet pills that claim to reduce the time and effort it will take to lose weight can cause great harm.
During the 1990s, doctors began to prescribe fenfluramine (Pondimin�), dexfenfluramine (Redux�), and phentermine, more commonly known as Fen-Phen to increase the weight loss effect. These diet drugs aid in weight loss by altering the serotonin levels in the brain to suppress feelings of hunger. Serotonin is a naturally occurring hormone that acts as a neurotransmitter and affects mood, appetite and sensory perception. A lack of serotonin in the brain is thought to be associated with depression, while higher levels of serotonin can cause a sense of euphoria.
While these drugs are individually approved by the Food and Drug Administration (FDA), the combination of the drugs is not. When these drugs are combined, there are potentially serious adverse side effects and various studies have demonstrated the serious potential health risks associated with the use of these drugs.
Symptoms associated with the use of Fen-Phen include:
• Shortness of breath.
• Chest pain.
• Swelling of feet.
• A new heart murmur.
Problems associated with the use of Fen-Phen and other diet pills include:
• Serious heart murmurs.
• Heart valve leaks.
• Thickening of the heart valves.
• Heart valve regurgitation (a build-up of a plaque-like substance on the heart valves).
In 1997, the Mayo Clinic conducted a study and reported that heart valve dysfunction was found in 30% of Fen-Phen users who were given diagnostic echocardiograms. In addition to heart valve damage, Fen-Phen was found to cause Primary Pulmonary Hypertension (PPH) in some users.
PPH is a rare but serious condition affecting the arteries in the lungs; it is a progressive condition and can become 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.
As PPH, progresses the symptoms include:
• Shortness of breath (dyspnea).
• Dizziness or fainting spells.
• Chest pressure or pain.
• Swelling in the ankles, legs and eventually the abdomen.
• Bluish color to your lips and skin.
• Racing pulse or increased heart rate.
Some 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.
These alarming findings led the FDA to withdraw Fen-Phen from the market in September 1997. The FDA, along with the Center for Disease Control and the National Institute of Health, recommended that individuals who have taken Fen-Phen discontinue use and consult a doctor to determine if negative side effects develop.
The health problems associated with the use of Fen-Phen have resulted in individual and class action lawsuits. Lawsuits filed for such injuries allege, among other things, that some of the manufacturers and distributors of the drugs were aware of the health risks associated with the drugs and failed to provide adequate warnings of such risks.
A National Class Action Settlement with American Home Products Corporation, the manufacturer of Fen-Phen, was filed. Final judicial approval of the settlement was received in 2002, and was settled for $4 billion.
Fen-Phen and Redux — Withdrawn From Market
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. 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.