Redux was approved in 1996 and withdrawn on Sept. 15, 1997, after heart valve damage was detected in patients using the drug. There is evidence, however, that the dangers of the drug were known for some time. In 1995, while the drug was in the approval stage, the lead FDA medical officer reviewing Redux believed the drug had low effectiveness and very high risk for neurotoxicity and pulmonary hypertension. The FDA nevertheless decided to approve the drug. During its one year on the market, Redux generated sales of $ 255.3 million. Since its approval, however, there have been 123 related deaths from patients using Redux.
Lawsuits now pending allege that Redux is linked to heart-valve disease and an often fatal lung condition known as Primary Pulmonary Hypertension (PPH). About 6,000 lawsuits to date have been filed on behalf of 11,000 plaintiffs who took the diet drug.
Former users filing lawsuits also allege that the company failed to adequately disclose the risks of these conditions. American Home Products, the manufacturer of Redux, has contended it acted responsibly. In the wake of increasing litigation, however, American Home Products has agreed to pay or set aside $ 3.75 billion to settle lawsuits related to the drugs' potential to cause heart valve damage for the next 15 years. Factoring inflation, the company's payment to plaintiffs spread over that time could amount to $4.83 billion. According to a Boston University School of Medicine study, 28% of Fen-Phen/Redux users have heart valve damage. That means that out of the 6 to 7 million users who were prescribed Fen-Phen/Redux, almost 2 million former users have heart valve damage. So far, fewer than 500,000 users have received compensation from lawsuits.