Duract

In 1998 Duract was voluntarily withdrawn by Wyeth-Ayerst Laboratories due to postmarketing reports of rare, but serious liver events associated with long-term use.

Duract is an NSAID that was approved in July 1997 for short-term management of acute pain and was never approved for longer-term use. A Duract label change had been made February 10, 1998 to warn of the serious risks associated to the analgesic.

At the time of the Duract withdrawal the FDA had received reports of 4 deaths, 8 patients who survives but required liver transplant, and 12 other patients with serious but less severe liver damage. Later, more Duract adverse effects and fatalities were discovered to have occurred.

• Liver Damage
• Severe Hepatitis

• Duract Press Release
• Warning Label Changes For Pain Reliever Duract