Word: ayerst
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...some respects Redux has been a victim of its own early success. The first new antiobesity medication in more than 20 years, the drug enjoyed one of the fastest launches in pharmaceutical history. Both the FDA and Wyeth-Ayerst Laboratories, which markets Redux, knew about the possibility of brain damage at high doses. But they also knew people who are morbidly obese--individuals who weigh 30% more than average--face even greater risks that they will die young from heart disease, diabetes or stroke. "We made the decision that the benefits outweigh the risks, at least for the population...
Still, the FDA was not entirely satisfied, and as a condition of approval it required that Wyeth-Ayerst conduct a follow-up study to determine whether Redux users were suffering any ill effects from the drug. Wyeth-Ayerst's critics say the company has been dragging its feet. Wyeth-Ayerst, for its part, says it is pleased with Redux's sales and is ready to start the tests, but that the FDA still has not decided how the study should be designed...
...meantime, the drug has become a magnet for bad press--most of it unwarranted, if not downright false. In February, after the FDA met behind closed doors with officials from Wyeth-Ayerst to iron out details of the follow-up study, critics cried "cover-up"--as if the FDA never granted drug companies private meetings in order to protect trade secrets. In April the Associated Press reported that a 38-year-old, 120-lb. woman had died after taking Redux for just a few days. It turned out that she weighed 220 lbs. and was in fact murdered--a turn...
...groups, had been reluctant to package or promote their pills as safe for use after sex. The companies are still reluctant: The FDA, in a highly unusual action, approved a new use for the drug even though the manufacturers hadn't asked the agency to. Approved brands include Wyeth-Ayerst Laboratories' Ovral, Lo/Ovral, Nordette and Triphasil, and Berlex Laboratories Levlen and Tri-Levlen. Wyeth said that despite the announcement, it would not market pills as a "morning-after" product in the U.S. Although emergency contraception is not an abortive drug, many anti-abortion groups still oppose it. Serrin Foster, president...
That doesn't mean the FDA has declared Redux to be entirely safe. As a condition of approval, the agency is requiring Wyeth-Ayerst to do follow-up testing. "We're concerned," says Bilstad, "that there could be subtle effects that you can pick up only in a clinical study." Among the possibilities: troubling changes in mood, like depression and aggressiveness, that might derive from a serotonin deficit...