Duract was first introduced in July 1997. Almost immediately from its introduction, 2.5 million prescriptions were dispensed. Seven months after Duract's market launch, however, numerous cases of severe liver damage were being reported. The reports came from users who took the drug for more than 10 days.
In February 1998, Wyeth-Ayerst, the manufacturer, and the Food and Drug Administration (FDA) agreed to label changes to emphasize that Duract should be used for 10 days or less. Wyeth-Ayerst Labís compliance, however, only went as far as to put on the 135th line the label's fine print that Duract was recommended for "generally less than 10 days."
By June 1998, Wyeth-Ayerst Laboratories, a division of American Home Products (AHP) announced the recall of Duract because of post-marketing reports of severe hepatic (liver) failure resulting in four deaths and eight liver transplants. In almost all of the deaths, the patient took the drug longer than 10 days. By late 1998, the FDA had received voluntary reports citing Duract as a suspect in 68 deaths, including 17 that involved liver failure. During its one year on the market, Duract generated sales totaling $ 89.7 million for Wyeth-Ayerst. In March 2001, a Texas court approved nationwide class action of Duract users who have not yet shown signs of the liver damage developed by some who used the anti-inflammatory drug for just a few days.
Ted Machi & Associates, 1521 N. Cooper, Ste. 550, Arlington, Texas
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