Duract (Bromfenac)

Development and Release

Duract was developed as a non-steroidal anti-inflammatory drug (NSAID) in the mid-1990s by Wyeth-Ayerst, and was approved by the U.S. Food and Drug Administration (FDA) for sale ato treat short-term acute pain in 1997. Before its recall in June of 1998, Duract was prescribed to 2.5 million patients and made the company $89.7 million in revenue.

Health Problems Associated With Duract

There were questions about Duract’s interaction with the liver even prior to the drug’s approval by the FDA, but neither Wyeth nor the FDA realized how serious the problem really was. Soon after prescriptions were issued, reports of liver problems began to surface. After a few months, the company found that Duract could result in liver damage to patients who took the drug for 10 days or more. Unfortunately, the seriousness of the risk was not apparent in pre-market clinical trials because no patient was treated for more than 10 days during such testing.

Wyeth-Ayerst’s Response

After discovering the increased likelihood of adverse side effects in patients who took the drug for 10 days or more was discovered in February 1998, Wyeth put a warning on Duract’s label indicating the risk. The company took additional measures, directly addressing healthcare professionals regarding the need to warn patients. Even after Wyeth took these preventative measures, news of four more deaths, eight liver transplants, and a multitude of incidences of significant liver damage was reported. As a result, Wyeth decided the risk of continued use of the drug outweighed its benefits and issued a recall of Duract in June 1998.

Legal Response

The first lawsuit against Wyeth for harm caused by Duract was filed in early 2000. Eventually the plaintiffs organized as a class, and were approved to file a class action lawsuit by a Texas court in March of 2001. The class action was dismissed on appeal, however, and the plaintiffs had to file individual lawsuits. Eventually, Wyeth reached a confidential settlement with each individual plaintiff.

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rlg Previous Comments

  1. Guest
    on September 4, 2012 at 7:50 pm

    My husband died 2/14/98. I was contacted by the FDA in May of 98 stating he was one of the 11 who died while taking Duract.

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