Lieff Cabraser Heimann & Bernstein, LLP Press Release, "Class Action Lawsuit Filed Against the Manufacturer of the Diet Drugs Known as Fen-Phen and Redux"

          With co-counsel, Lieff Cabraser Heimann & Bernstein, LLP announces the filing of a class action lawsuit in the San Francisco federal district court naming as defendants the manufacturers of the prescription diet drugs known as Fenfluramine, Phentermine (known as Fen-Phen), and Dexfenfluramine (known as Redux). According to a study by the Mayo Clinic and the International Primary Pulmonary Hypertension Study, this combination of weight-loss drugs may have deadly side-effects.
          A Mayo Clinic report released yesterday, July 8, 1997, reports a clinical observation of unusual valvular heart disease in patients who had taken a combination of FenPhen. Some of the patients had newly documented pulmonary hypertension, a sometimes fatal disease of the heart and lungs. The lawsuit requests as part of its prayer that there be a medical monitoring fund established to enable those people who have taken these diet supplement prescription drugs to monitor the existence of dangerous side effects that may have been caused by the drugs. Doctors wrote an estimated total of 18 million monthly prescriptions for these drugs in the United States last year alone. The PhenPhen and Redux medications were widely and aggressively advertised as the medications that would allow you to eat and live like a "normal" person. The drugs used in combination appear to pose risks of severe, possibly life threatening, health problems and were never authorized by the FDA to be used in combination.
          Cases of pulmonary hypertension have also occurred in people taking Dexfenfluromine, or Redux, a similar anti-obesity drug that received FDA approval last year. A director of the FDA's metabolic and endocrine drug products division said, "we are extremely concerned" about potential complications from these drugs.
          Although the FDA has approved Fenfluramine and Phentermine separately, the FDA has not approved these drugs for combination use. The lawsuit alleges that the manufacturers and distributors of these drugs knew of and encouraged the prevalence of off-label use of their drugs, and failed adequately and appropriately to warn physicians and consumers that their Fen-Phen drug regimen was not FDA approved, was not recommended, and had not been systematically tested by appropriate clinical trials.