Pharmaceutical Litigation
Duract®
Manufacturer:
Wyeth-Ayerst Laboratories
Uses: A painkiller used to alleviate pain caused by a variety of ailments.
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| 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In 1998 Duract was voluntarily withdrawn by Wyeth-Ayerst Laboratories due to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.
Side Effects
- Liver Damage
- Severe Hepatitis
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