Background
Fen-Phen is a combination of two Diet drugs, Fenfluramine (Pondimin) or the closely related Dex-fenfluramine (Redux) and Phentermine. Both Fenfluramine and Phentermine were available for decades as separate diet drugs and both were available for short term use. In April 1996, the FDA approved Dexfenfluramine (Redux) for long term use partly because the FDA considered the risks of obesity to outweigh the risk of a developing a serious potential side effect, Primary Pulmonary Hypertension (PPH). The FDA, however, did not approve the use of these two drugs as a combination weight loss medication.
Despite lack of FDA approval for the drug combination, sales of Fen-Phen skyrocketed following a 1992 study which reported that patients treated with Fen-Phen lost an average of 30 pounds. Following this study, Fen-Phen was heavily touted in the media as a miracle weight loss solution and was aggressively marketed by its manufacturer, American Home Products Corp. /Wyeth-Ayerst Laboratories. As a result, Fen-Phen became extremely successful for American Home Products Corp. /Wyeth, and it is estimated that by 1996, as many as 18 million Fen-Phen prescriptions had been written.
Primary Pulmonary Hypertension (PPH)
In 1996, the New England Journal of Medicine published the results of a study which showed a disturbing increase in the rate of Primary Pulmonary Hypertention (PPH), in patients who used Fen-Phen.
PPH occurs when the blood pressure in the arteries supplying the lungs is abnormally high. It is caused by a narrowing of the blood vessels that lead into the lungs, which in turn causes the heart to pump harder. As a result, patients get extremely fatigued, suffer from shortness of breath, and can develop chest pain. PPH is quite rare - occurring in only one or two people per million. However, studies show that Fen-Phen users have an increased risk of PPH by 23 to 43 times the average. Alarmingly, the 4 year mortality rate for PPH is 45%.
Valvulopathy with Fen-Phen
In July of 1997, the Mayo Clinic and Mayo Foundation released the results of a study that showed that Fen-Phen users were also at much higher risk of developing serious heart valve disorders. Based on this Study, the FDA issued a Public Health Advisory regarding the two drugs. When the FDA looked at Echocardiograms from Fen-Phen users, over 30% showed abnormal heart valve function, even if the patient had no symptoms. Fen-Phen can affect any of the heart valves, but left sided valve issues were noted in every case. Serious cases can lead to valve replacement, heart failure, or death. Click here to see Full CDC report.
FDA recommendations for those who have taken Fen-Phen
•1. All persons exposed to fenfluramine or dexfenfluramine, for any period of time, either alone or in combination with other agents, should undergo a medical history and cardiovascular examination by their physician to determine the presence or absence of cardiopulmonary signs or symptoms.
•2. An echocardiographic evaluation be performed on all persons who were exposed to fenfluramine or dexfenfluramine for any period of time, either alone or in combination with other agents, and who exhibit cardiopulmonary signs (including a new murmur) or symptoms suggestive of valvular disease (e.g., dyspnea).
•3. Although the clinical importance of asymptomatic valvular regurgitation in exposed patients and the risk for developing bacterial endocarditis in these patients are unknown, practitioners should strongly consider performing echocardiography on all persons-regardless of whether they have cardiopulmonary signs or symptoms-who have been exposed to fenfluramine or dexfenfluramine for any period of time, either alone or in combination with other agents, BEFORE the patient undergoes any invasive procedure for which antimicrobial endocarditis prophylaxis is recommended by 1997 AHA guidelines. Any echocardiographic findings that meet the AHA criteria for prophylaxis-regardless of whether they are attributable to possible fenfluramine or dexfenfluramine use-should be recognized as indications for antibiotic prophylaxis. The invasive procedures include certain medical or dental procedures where antibiotic prophylaxis is recommended as defined by the 1997 AHA guidelines. For emergency procedures for which cardiac evaluation cannot be performed, empiric antibiotic prophylaxis should be administered according to the 1997 AHA guidelines.
•4. Because of the prevalence of minimal degrees of regurgitation in the general population, the current case definition of drug-associated valvulopathy should include exposed patients with echocardiographically demonstrated AR of mild or greater severity and/or MR of moderate or greater severity, based on published criteria.
Fen-Phen Recall
On September 15, 1997, the FDA asked the manufacturers of Fenfluramine and Dexfenfluramine, American Home Products/Wyeth-Ayerst and Interneuron Pharmaceuticals, to voluntarily recall the drugs from the market. The drugs have been off the market since that time.
Lawsuits
Following hundreds of lawsuits, American Home Products/Wyeth entered into a Nationwide Settlement Agreement with the Fen-Phen Plaintiffs in November 1999. The Settlement Agreement covers various claims relating to heart valve defects, but excludes claims for development of Primary Pulmonary Hypertension (PPH).
If you took Fen-Phen and have developed either heart valve problems/valvular disorders or Primary Pulmonary Hypertension (PPH), please contact us toll Toll Free from Anywhere in the U.S. at 877.301.5913. Free Consultations - Se Habla Español.
