Q: What is Fen-phen?
A: "Fen-phen" refers to the use in combination of the drugs fenfluramine and phentermine, and phentermine and dexfenfluramine (also called "dexfen-phen"). In the 1990s, some physicians began prescribing fenfluramine or dexfenfluramine in combination with phentermine, often for extended periods of time, for use in weight loss programs.
Q: Did Fen-phen Receive FDA Approval?
A: While the prescription medications fenfluramine, phentermine, and dexfenfluramine received individual approval by the U.S. Food and Drug Administration (FDA), use of the drugs in combination never received FDA approval. Use of approved drugs in ways other than described in the FDA-approved label is called "off-label use." In the case of fen-phen and dexfen-phen, no studies were presented to the FDA to demonstrate either the effectiveness or safety of the drugs taken in combination.
Q: Why Was Fen-phen Withdrawn from the Market?
A: In September 1997, the FDA asked the manufacturers to voluntarily withdraw dexfenfluramine and fenfluramine from the market. The FDA's withdrawal request came after echocardiogram testing of fen-phen patients suggested that fenfluramine and dexfenfluramine were the likely cause of heart valve problems.
FDA recommended that patients using either of these products stop taking them, and advised patients to contact their doctors to discuss their treatment.
Q: What are the Heart Risks for Fen-Phen Users?
A: Patients who have taken fenfluramine and dexfenfluramine may have changes in their heart valves that cause leakiness and backflow of blood. If this is severe, the heart has to work harder. This may cause problems in heart function. If the disease is severe, the patient may experience such symptoms as shortness of breath, excessive tiredness, chest pain, fainting, and swelling of the legs (edema).
Q: With the Removal of Fen-phen from the Market, What Should Overweight Persons Do If They Want to Improve Their Health?
A: The FDA and Centers for Disease Control and Prevention (CDC) recommend that persons who are less than 20% overweight begin a life-long program of moderate physical exercise -- such as brisk walking for 30 to 45 minutes -- on most days of the week. Regular moderate physical activity is likely to improve weight control and will also strengthen the heart. Overweight persons should also begin to make moderate and life-long changes in their food choices and eating practices, including reducing the total amount of calories they eat and ensuring that their diet is low in saturated fat and rich in fruits and vegetables.
Persons who have a significant weight problem are advised to consult their physician to develop a strategy that is individualized for them. There are a number of options available that a physician can discuss with the patient.
Q: Have Their Been Any Lawsuits Filed Over Fen-Phen?
A: Since fenfluramine and dexfenfluramine were pulled from the market, hundreds of former fen-phen patients have filed lawsuits against the drugs' manufacturers, including a nationwide class action suit that was settled and received judicial approval in January 2002. If you or a loved one have suffered illness or injury as a result of fen-phen drug use, your rights may be impacted by the nationwide class action or by other legal proceedings related to fen-phen. But you may still be entitled to file a lawsuit for any harm caused by fen-phen drug use, especially if your health problems or risks were discovered only recently. The best way to ensure that your legal rights are protected is to contact an attorney, who will consider your case and explain your options.