PPH Defined for Class Settlement: Fen-phen was a diet drug combination of Fenfluramine (“fen”) and Phentermine (“phen”) that became popular in the early 1990s. In September 1997 American Home Products (now known as Wyeth), the company responsible for the drugs, withdrew Fenfluramine (brandname Pondimin®) and the related drug Dexfenfluramine (brandname Redux?) from the market. Wyeth withdrew the drugs after discussions with the FDA and after increasing reports of valvular heart disease associated with the drugs. Case reports, epidemiological studies and other research has shown that PPH is also associated with the use of Fenfluramine and Dexfenfluramine.

After the withdrawal of Fenfluramine and Dexfenfluramine, the FDA issued the following interim recommendations to users of the drugs:

“The U.S. Department of Health and Human Services (DHHS) is issuing the following interim recommendations for persons previously exposed to fenfluramine or dexfenfluramine. These recommendations have been developed collaboratively by CDC, FDA, and the National Institutes of Health (the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases) in consultation with the American Heart Association, the American College of Cardiology, and the American Dental Association and are based on data associating exposure to these drugs (as single agents or as part of combination therapy) with cardiac valvulopathies. As more definitive data about the natural history of the disease become available, these DHHS interim recommendations may be revised. To determine whether valvulopathy is present in potentially affected persons and to provide such persons with optimal care, DHHS recommends that:

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 (7,8).”

To read the entire Morbidity and Mortality Weekly Report of November 14, 1997 in which the interim recommendations were published, click here.

Fen-Phen Litigation: Since the withdrawal of the drugs from the market, numerous lawsuits have been filed alleging personal injuries (including PPH and valvular heart disease) as a result of using the drugs. Several cases have gone to trial, and many cases have settled. A national class settlement was reached that includes valvular heart disease claims, but does not include PPH claims.

The national diet drug class settlement does not cover PPH claims. As such, PPH claimants can bring independent lawsuits to pursue their PPH claims against Wyeth. However, in order to bring such a lawsuit, the claimant must either: have filed an initial opt-out to the class settlement or meet the class settlement definition of PPH.

To read the portion of the class settlement agreement defining PPH, click here.

To read the entire class settlement agreement or for more information about the diet drug class settlement, click here to visit the website.