Duract

In June 1998, Wyeth-Ayerst Laboratories, a division of American Home Products Corporation announced the recall of Duract because of postmarketing reports of severe hepatic (liver) failure resulting in four deaths and eight liver transplants.DURACT (bromfenac sodium capsules), is a nonsteroidal anti-inflammatory analgesic indicated for the short-term (10 days or less) management of acute pain.

DURACT was introduced in July 1997, and approximately 2.5 million prescriptions have been dispensed -- the great majority of these for 10 days or less. In February 1998, the company and the Food and Drug Administration agreed on labeling changes to further emphasize that DURACT should be used for 10 days or less. These changes were initiated in response to earlier reports of serious events associated with longer-term use.

"Although the revised labeling reduced the number of prescriptions of longer duration and the reports of severe liver events, it did not eliminate them," says Dr. de Vane. "The company has now concluded that further steps to limit use of a potent NSAID pain reliever such as DURACT to just 10 days would not be feasible or effective. In light of these circumstances, as well as the availability of other therapies, Wyeth-Ayerst has decided to withdraw the product."

Wyeth-Ayerst has sent letters of notification to more than 600,000 health care professionals in the United States. They are being advised to stop prescribing and dispensing DURACT immediately. In addition, they have been asked to consider contacting patients who may be using the product longer than 10 days or who have a history of liver disease, and advise these patients to discontinue treatment. Patients are advised to discuss concerns related to DURACT with their physician.

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