NSAID Duract pulled
Despite Food and Drug Administration approval calling for short-term use and labeling revisions stressing that point, Wyeth-Ayerst has taken its nonsteroidal anti-inflammatory Duract (bromfenac sodium) off the market due to serious and ongoing cases of hepatic failure associated with long-term use of drug.
Though labeled for a short-term regimen of 10 days or less for pain relief, most hepatic failure blamed on the drug came after extended use. Of 12 serious cases of hepatic failure reported, four patients died and eight needed liver transplants. Another dozen cases of less severe liver damage have also been associated with the use of Duract.
Even before the drug hit the market, studies had shown that patient liver enzyme levels became elevated after 30 days or more on the drug. Duract was labeled for short-term use when it became available in July 1997, but stronger labeling warnings added in February of this year did not stop long-term use from occurring, either by physician prescription or patient habits. Company officials doubt they will attempt to remarket the drug.
[For more information, call Wyeth-Ayerst at (800) 934-5556.]
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