FDA
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Food and Drug Administration
U.S. Department of Health and Human Services
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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T98-36                        Print Media:         301-827-6242
June 22, 1998                 
                              Consumer Inquiries:  800-532-4440

WYETH-AYERST LABORATORIES ANNOUNCES
THE WITHDRAWAL OF DURACT FROM THE MARKET

Wyeth-Ayerst Laboratories of St. Davids, Pa. has announced that it is voluntarily withdrawing the analgesic, Duract (bromfenac) from the market. The action follows postmarketing reports of rare severe liver failure in patients in whom the drug was used for extended periods of time which was not in accordance with labeling instructions. The following may be used to respond to questions.

Duract, a non-steroidal anti-inflammatory drug (NSAID), was submitted to the Agency in l994 and was approved in July l997 for short term management of acute pain (use for 10 days or less). It was never approved as a treatment for longer term use for chronic conditions such as osteoarthritis or rheumatoid arthritis.

No cases of serious liver injury were reported in clinical trials, however, because there was a higher incidence of liver enzyme elevations in patients treated long term in clinical trials, the product was approved for use for 10 days or less. The information about the elevated liver enzymes was included in the product labeling.

After Duract was marketed, FDA and the company received reports of several cases of rare severe hepatitis and liver failure (some requiring transplantation) in patients taking the drug for more than 10 days.

In February l998, in response to the reports of severe liver failure (and transplants), FDA and the company strengthened the warnings in Duract's labeling with a special black box warning and Wyeth-Ayerst issued a Dear Doctor letter. The revised label re-emphasized that patients should not take the drug for more than 10 days and alerted physicians and other health care professionals to the cases of severe hepatitis and liver failure (and cases in which patients required a transplant) in patients who had taken Duract.

Despite these efforts, the agency and the company continued to receive reports of severe injuries and death with long term use of Duract.

Given the availability of other therapies, FDA and Wyeth-Ayerst concluded that it would not be practical to implement the restrictions necessary to assure the safe use (less than 10 days) of Duract. The company and FDA agreed that it would be prudent to withdraw the drug from the market. Wyeth-Ayerst is advising doctors to discontinue prescribing and dispensing Duract immediately.

FDA is also advising patients to contact their doctors with any questions about use of the drug. Wyeth-Ayerst is providing the new information in a Dear Doctor letter to physicians, pharmacists, and health care professionals. Questions from patients or health care professionals about the withdrawal of Duract can be addressed to Wyeth-Ayerst's hotline at 1-800-281-9260.

For more information about the withdrawal of Duract from the market, see:

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