Word: redux
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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...
...would they? After all, other serotonin enhancers, such as Prozac, have never caused heart problems. There is a crucial difference, however, between Prozac and Redux-fenfluramine. The former, like the other SSRIS, keeps serotonin in circulation longer than it would otherwise be, thus helping the brain get the most out of its normal output. The latter do the same, but they also force nerve cells to boost the levels of serotonin that go into circulation. It is this unnatural bath of excess serotonin, some scientists theorize, that causes heart-valve defects and also triggers brain damage--in monkeys...
...Redux and fenfluramine are too powerful for the body to handle--a proposition not fully accepted by some doctors despite the FDA and manufacturers' action--research into serotonin-boosting drugs is hardly slowing down. If anything, the discovery of a new set of side effects will spur researchers to hone their pharmacological handiwork even more, to create medicines that will not just fine-tune the way serotonin is used in the brain but might target specific serotonin receptors as well or act on only specific parts of the brain and nervous system...
...finger pointing that followed last week's abrupt withdrawal of two of the country's favorite diet pills looked like a multiple-choice law-school torts exam, the similarity was hardly coincidental. Even before the FDA urged the recall of Redux (dexfenfluramine)--and Pondimin (fenfluramine), the front half of the fat-pill combo known as fen/phen--scores of lawyers across the nation had already started filing lawsuits. After the recall, the legal assault turned into a stampede. "Everyone saw money," says Jacoby & Meyers' Gail Koff...
...seeking any individuals who felt they had been hurt by the capsules. New York lawyer Paul Rheingold, author of four suits so far, describes the diet-pill debacle as such "easy" pickings that he expects "many thousands of lawsuits scattered all around the country." Eventually, say some analysts, the Redux-fenfluramine recall could grow into one of the biggest medical-liability cases in history, perhaps exceeding the anticipated $2.4 billion from silicone breast implants...