Signs of Liver Problems: Duract Posed Danger to Liver
May 20, 2001
Duract, a popular painkilling medication manufactured by Wyeth-Ayerst Laboratories, poses a serious threat to liver function. While Food & Drug Administration researchers investigating whether to approve new drugs always consider the proposed drug's effect on the liver, Duract's negative impact on the liver was clearly evident from the start of the investigational process. Despite the agency's misgiving regarding Duract's safety, the drug was approved for use in July 1997.
Prior to approval, FDA's Dr. John Hyde had this to say about Duract: "It seems imprudent to open the doors to extensive use when there have been early warning signs . . . The [liver] toxicity is a significant concern with this drug." Apparently Dr. Hyde's superiors at the FDA did not share his concern. In hindsight they should have.
As a compromise, Dr. Hyde and his FDA colleague Dr. Rudolph Widmark suggested approval if Wyeth-Ayerst agreed to place a prominent warning on Duract packaging regarding the drug's potential for causing liver damage. Wyeth-Ayerst balked and requested that the powers that be at the FDA approve Duract without such warnings. Rather than a prominent warning that Doctors Hyde and Widmark suggested, the FDA approved Duract packaging that did not mention the possibility of liver problems until the 135th line of the small print package insert.
Within months of Duract's approval, cases of liver failure began to appear, many requiring liver transplants and some resulting in death. These episodes led the FDA to insist on a "black box" warning on Duract packages. The FDA said "Patients using Duract for more than 10 days have developed jaundice, fulminant hepatitis and liver failure requiring transplants."
In June of 1998 Duract was removed from the market after causing at least 68 deaths.
-- Article Courtesy of InjuryBoard.com
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