Q: What is “Fen-phen”?
A: “Fen-phen” refers to the combination of the drugs, namely fenfluramine and phentermine, and phentermine and dexfenfluramine (also known as “dexfen-phen”). There were several doctors who started to prescribe fenfluramine or dexfenfluramine in combination with phentermine in 1990, which is usually for use of prolonged period of time and for weight loss programs.
Q: Did Fen-phen receive FDA approval?
A: The prescription medicines fenfluramine, phentermine, and dexfenfluramine received an individual approval from the US Food and Drug Administration but the use of combined drugs was never obtained any approval from the FDA. The use of the approved drugs in ways not recognized by the FDA is called as “off-label use.” With the fen-phen and dexfen-phen cases, there were no studies neither conducted nor presented to FDA to show and prove how these combinations of drugs work or the safety of these combined drugs.
Q: Why was Fen-phen recalled from the market?
A: It was in September 1997 when US FDA asked the manufacturers to withdraw voluntarily the dexfenfluramine and fenfluramin from the market. The recall was a result of the echocardiogram testing of fen-phen patients that showed that fenfluramine and dexfenfluramine has the risks to cause heart valve problems. FDA, hence, declared that the patients who were using either of these products to discontinue using them and advised them to contact their doctors immediately and discuss their medication.
Q: What are the heart risks for “fen-phen” users?
A: Patients who have used fenfluramine and dexfenfluramine may experience changes in their heart valves that can lead to leakiness and backflow of the blood. If this is severe, then the heart must work harder, and may lead to some heart function problems later. If the illness is severe, the patient may experience one or more of these symptoms: extreme exhaustion, shortness of breathing, chest pain, fainting, and swelling of the legs, known as edema.
Q: With the withdrawal of Fen-[hen from the market, what should individuals with overweight problems do if they want to improve their health?
A: The US FDA and the Center for Disease Control and Prevention or CDC are recommending these persons who are below 20% overweight to start a life-long program of moderate physical activity such as brisk walking for at least 30 to 45 minutes – on most days of the week. Regular moderate physical activity will tend to improve weight condition and strengthen the heart. Overweight persons should start making moderate and life-long changes in their food choices and eating habits, including reducing the total amount of calories they eat and making sure that their diet is low in saturated fat and rich in fruits and vegetables. People who have some weight problems are recommended to consult their doctors to create a customized weight loss program for them. There are several options available that a doctor can discuss with the patient.
Q: Were there any lawsuit filed against Fen-Phen?
A: Since fenfluramine and dexfenfluramine were removed from the market, there were hundreds of previous fen-phen patients who have filed lawsuits against the drug manufacturers, which includes a countrywide class action suit that was settled and received a judicial approval in January 2002.
If you or any of your family member experienced disease or injury as a consequence of using fen-phen drugs, your rights may be affected by the class action or other legal proceedings which as associated with fen-phen drug. However, you may still be entitled to file a lawsuit for any injury sustained due to the use of fen-phen, particularly if your illness has only been discovered quite recently. The best way to make sure that your legal rights are protected, look for an experienced lawyer and discuss with him your condition and know your rights.