June 22, 1998

Dear Healthcare Professional:

Wyeth-Ayerst Laboratories announced today the voluntary market withdrawal of DURACT (bromfenac sodium capsules), a nonsteroidal anti-inflammatory analgesic indicated for the short-term (10 days or less) management of acute pain. The company is taking this action based on postmarketing reports of severe hepatic failure, resulting in four deaths and eight liver transplants.

Approximately 2.5 million prescriptions have been dispensed since DURACT was launched in July 1997. The great majority of those prescriptions were for 10 days or less, a duration of treatment which we continue to believe is safe and effective. All but one of the 12 reported deaths and transplants occurred among the relatively small percentage of patients who took DURACT for more than 10 days. The exception was a person who had pre-existing significant liver disease.

In February 1998, Wyeth-Ayerst Laboratories 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 hepatic events associated with longer-term use. After this action, the number of prescriptions for longer duration use, as well as the number of reported serious hepatic events, was reduced but not completely eliminated. The company has now concluded that further steps to limit use of a potent NSAID analgesic 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 this product.

Please discontinue prescribing and dispensing DURACT immediately. You should consider contacting patients who may be taking DURACT for longer than 10 days or who have a history of liver disease. Any such patients should discontinue DURACT treatment. You or your patients may call 1-800-281-9260 with any questions regarding DURACT.

Sincerely,

Philip J. de Vane, M.D.
Vice President, Clinical Affairs
and North American Medical Director

Pharmacists will receive additional correspondence within the next few days concerning returning product for credit.

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