Redux is a diet drug that was approved for use by the Federal Drug Administration in 1996 and withdrawn on Sept. 15, 1997, after heart valve damage was detected in patients using the drug. During its one year on the market, Redux generated sales of $ 255.3 million. There have been 123 deaths related to use of 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. There is evidence that the dangers of the drug were well known before it was removed from the market. 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 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. According to a Boston University School of Medicine study, almost 2 million former users have heart valve damage. So far, fewer than 500,000 users have received compensation from lawsuits. Click on Redux/Pondimin Settlement Agreement, to see the terms of the national settlement.
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