Word: ayerst
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SLEEP ALL NIGHT The ability to sleep soundly decreases with age. Sonata, which American Home Product's pharmaceutical unit Wyeth-Ayerst hopes to launch next year, is designed to induce sleep without producing a groggy feeling the next morning. "There is a tremendous issue in sleep disturbance," says consultant Coleman. "So when we get a product that people have utter confidence in, that will be a gold mine for someone...
...problems much more serious than a dull sex life. Just 1 1/2 years after it approved Redux for treatment of obesity, the FDA issued a warning advising patients to stop taking it and its close chemical cousin fenfluramine immediately. At the same time, the drugs' manufacturers and distributors, Wyeth-Ayerst Laboratories, told physicians to stop prescribing them and took the dramatic step of pulling both medications from the market. The reason for such haste: new evidence had revealed that as many as 30% of Redux and fen/phen users could develop abnormalities in the shape of their heart valves--changes that...
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...
...boosts the metabolism to burn calories faster. Wurtman separated fenfluramine 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...
Much of this legal furor is being vented against Wyeth-Ayerst Laboratories, a subsidiary of American Home Products, which makes fenfluramine and distributes dexfenfluramine, and Interneuron Pharmaceuticals, a small Lexington, Mass., firm founded by the M.I.T. neurologist who developed Redux. There's also talk of bringing action against the FDA--though federal law usually protects government officials from suits challenging routine performance of duties like approving drugs. Whatever the outcome of the legal battles, they leave unsettled larger societal questions--about Americans' infatuation with quick-fix remedies for whatever ails them, real or imagined, and their doctors' willingness to cater...