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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (382)	6/22/1998 1:29:00 PM
From: Anthony Wong	Respond to of 1722

American Home Withdraws Painkiller Duract on Liver Side Effects Bloomberg News June 22, 1998, 9:45 a.m. PT American Home Withdraws Painkiller Duract on Liver Side Effects Madison, New Jersey, June 22 (Bloomberg) -- American Home Product Corp., maker of Advil painkiller and Centrum vitamins, said it voluntarily withdrew its painkiller Duract on reports of four deaths and eight liver transplants among users of the drug. American Home said 11 of the patients had taken Duract for more than 10 days, the recommended duration of treatment. In the other case, the patient already had significant liver disease, the Madison, New Jersey-based drugmaker said. American Home fell 9/16 to 519/16 in early afternoon trading. Duract was introduced last July and about 2.5 million prescriptions have been dispensed. In February, the U.S. Food and Drug Administration and American Home agreed to change Duract's label to further emphasize that Duract shouldn't be taken for more than 10 days. During the development of the drug there were no incidents of liver failure or damage, the FDA said. Still, patients taking the drug for longer periods did generate higher levels of certain enzymes associated with liver damage and so approval was limited to use for 10 days or less, the agency said. ''Given the availability of other therapies the FDA and Wyeth-Ayerst concluded that it would not be practical to implement the restrictions necessary to assure the safe use of Duract,'' the FDA said in a Talk Paper written to address the withdrawal. --Kerry Dooley in the Princeton newsroom (609) 279-4016/dd