Word: fda
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Dates: during 1990-1999
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...millions of Americans will be getting the chance to see if orlistat works for them as well. The FDA ruled last week that the drug, made by Hoffman-LaRoche, can go on sale in the U.S. The dark blue capsules, under the trade name Xenical, could be available by prescription as early as this week...
...short, the FDA has unofficially launched a gigantic, uncontrolled experiment on the U.S. population, much as it did with the diet drug Redux in 1996 and the impotence pill Viagra in 1998. The Redux fad ended abruptly a year later when some users developed serious heart-valve defects--and major side effects are always a possibility with Xenical as well. With Redux, though, hints of danger had shown up in clinical testing. That's not true of orlistat, either in animals or in human studies conducted in some of the 17 countries where the medication is already available. (An initial...
...result, about a third of the fat that would ordinarily be taken into the body is flushed right through the digestive system. Unfortunately, so are vitamins A, D, E and K, which bind to fat molecules. To make sure that patients don't develop vitamin deficiencies, the FDA requires that the Xenical label recommend that users take a multivitamin two hours before or after taking the drug...
That's not enough of a difference to justify putting orlistat on the market, says Dr. Jules Hirsch, an obesity expert at Rockefeller University and a member of the FDA advisory panel that evaluated the drug. Hirsch voted against approval. "We're talking about something that will take a little bit of weight off--a little more than a placebo--for a few years," he says, "but that will not make obesity vanish. The question is, How valuable is that...
Sources--Good News: FDA; American Association of Endodontists annual meeting. Bad News: Wall Street Journal (4/20/99), Circulation (4/20/99...