Redux

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Redux was approved in 1996 and withdrawn on Sept. 15, 1997, after heart valve damage was detected in patients using the drug.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...MORE >>

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