Word: fda
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Dates: during 1990-1999
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These were not the first lethal side effects associated with Redux and fenfluramine. When Redux was approved, both Wyeth-Ayerst and the FDA already knew that the medication could lead to a potentially fatal lung condition known as primary pulmonary hypertension. But this problem seemed to affect only a small minority of users, and morbid obesity carries significant risks of its own: heart disease, diabetes, high blood pressure and stroke. On balance, the benefits seemed to outweigh the risks...
...Partly because clinical trials reveal only the most obvious side effects; the heart-valve changes discovered over the summer do not initially cause visible symptoms in most patients. Also, many doctors went overboard, giving Redux and fen/phen to patients who were merely overweight, not obese, a violation of the FDA and drug-company prescription criteria that couldn't help skewing the risk-benefit ratio...
...neurochemists set about looking for a drug that would boost the influence of serotonin alone. In 1974, after a decade of work, Eli Lilly came up with Prozac, first of the so-called selective serotonin reuptake inhibitors, or SSRIS, and it was finally approved by the FDA...
...into its two component chemicals, levofenfluramine and dexfenfluramine. The latter has revealed itself to be a powerful weight-loss medication. He patented the drug for M.I.T., founded a company called Interneuron Pharmaceuticals to manufacture it under license to Wyeth-Ayerst and began moving the drug, dubbed Redux, through the FDA-approval process...
Some critics claim that Interneuron steamrollered Redux through the FDA and that the agency acted irresponsibly in approving it, charges that the company and the agency vigorously deny. What nobody on either side considered, though, was the possibility that either Redux or its parent compound fenfluramine might damage heart valves...