Fen-Phen
If you have suffered a personal injury as a result of the dangerous drug Fen-Phen, you may be eligble for compensation and should contact an attorney who specializes in product liability litigation and dangerous drug litigation against pharmaceutical companies.
What is "fen-phen"?
This is a US colloquial term for two drugs, phentermine and fenfluramine, used in combination as slimming pills. (As well as phin-fen, the forms fen-phen and are also common.)
Phentermine, sold as Adipex, Fastin and Ionamin among other trade names, is an appetite suppressant and a mild amphetamine-like anti-depressant that can help to make takers feel more energetic, and so burn off calories. Fenfluramine, sold under the name Pondimin, acts as an appetite suppressant by increasing the level of serotonin, which makes the body feel satiated.
What is the difference between fenfluramine and dexfenfluramine?
Fenfluramine (Pondimin) contains dexfenfluramine and levofenfluramine. Levofenfluramine may have some activities not directly related to appetite suppression. Dexfenfluramine (Redux) contains only dexfenfluramine.
What is the initial evidence that prompted withdrawal of fenfluramine and dexfenfluramine?
On July 8, 1997, the Mayo Clinic reported 24 patients developed heart valve disease after taking fen-phen. In five patients who underwent valve replacement surgery, the diseased valves were found to have distinctive features similar to those seen in carcinoid syndrome. The cluster of unusual cases of valve disease in fen-phen users suggested that there might be an association between fen-phen use and valve disease.
On July 8, FDA issued a Public Health Advisory that described the Mayo findings. The Mayo findings were reported in the August 28 issue of the New England Journal of Medicine, along with an FDA letter to the editor describing additional cases. FDA has received over 100 reports (including the original 24 Mayo cases) of heart valve disease associated mainly with fen-phen. There were also reports of cases of heart valve disease in patients taking only fenfluramine or dexfenfluramine. No cases meeting FDA's definition of a case were reported in patients taking phentermine alone.
What is valvular heart disease?
The heart contains four major valves that regulate the flow of blood through the heart and to the lungs and general circulation. Disease may cause excessive tightness (stenosis) or leakiness (regurgitation) of the valves. In the case of valve disease associated with fenfluramine and dexfenfluramine, leakiness is the problem. Valvular damage may ultimately produce severe heart and/or lung disease.
What is the relationship of fenfluramine and dexfenfluramine to heart disease?
Patients who have taken those drugs 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. However, the full medical implications of this relationship, especially in the asymptomatic patients, is not fully understood.
What are the signs and symptoms of valvular heart disease?
The patient may have no symptoms. The physician may hear a new heart murmur (abnormal sound as the blood flows over a valve), or the changes may be detected with a painless, non-invasive special heart test called an echocardiogram. An echocardiogram is usually performed by a cardiologist. 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).
Should I stop taking fen-phen, fenfluramine or dexfenfluramine right now?
Yes, this is the FDA's recommendation. Although we believe these drugs can be stopped at once for most persons, you should consult your physician about whether he/she advises you to taper the dosage over, for example, a 1 to 2 week period. The manufacturers of these drugs are withdrawing fenfluramine and dexfenfluramine from the marketplace, effective September 15, as the concerns about the effects of these drugs on heart valves continue to grow. The drugs will no longer be available in pharmacies. Though the potential long-term medical implications are not known at this time as there are still a number of unanswered questions, the FDA and the manufacturers believe it is in the best interest of the patients that they stop taking these medications. Please be aware that at present this recommendation does not apply to phentermine taken alone.
Should I get an echocardiogram if I've been taking fenfluramine or dexfenfluramine?
You should consult your physician about having an echocardiogram. Your physician's recommendation will depend upon your symptoms, if any, his or her examination of you and your history of exposure to these drugs.
