Pain reliever taken off market due to possible liver damage

FDA Consumer, Sept-Oct, 1998

The manufacturer of the pain medication Duract (bromfenac) withdrew the drug from the market after liver failure occurred in some patients who took the drug for more than the 10 days recommended in the labeling.

Duract, a nonsteroidal anti-inflammatory drug, was approved in July 1997 for short-term treatment of acute pain. The drug was not approved for longer use because clinical trials revealed a higher incidence of elevated liver enzymes with such use.

Reports that several patients who took the drug for longer than 10 days experienced severe hepatitis and liver failure prompted the manufacturer, Wyeth-Ayerst, St. Davids, Pa., in February 1998 to add a black-box warning to the labeling and send a "Dear Doctor" letter to health-care professionals about the reactions.

But FDA and Wyeth-Ayerst continued to receive reports of severe injuries and death from long-term use of the drug. Given that other therapies are available, the agency and Wyeth-Ayerst agreed last June to withdraw Duract from the market.

FDA says patients with questions should contact their doctors. Also, patients and health-care providers can call Wyeth-Ayerst at 1-800-281-9260.