February 1998

Dear Health Care Professional:

Recently cases of severe hepatitis and liver failure (some requiring transplantation), have occurred in patients who were taking DURACT (bromfenac sodium capsules). Each of these patients had taken DURACT for more than one month without liver enzyme monitoring. Although only a few cases have occurred to date, the actual incidence of these events is unknown. While no definitive cause for the occurrence of these adverse hepatic events, or the role of DURACT has been established, these patients were all receiving DURACT. Some non-steroidal anti-inflammatory drugs are known to carry the risk of severe hepatotoxicity.

Based on this recent experience during marketed use, Wyeth-Ayerst Laboratories has revised the DURACT labeling to include the following boxed warning:

WARNINGS
Hepatic Effects
Severe hepatic reactions, including jaundice, potentially fatal fulminant hepatitis and liver failure (some requiring transplantation), have occurred in patients taking DURACT for longer than the recommended duration. DURACT is a nonsteroidal anti-inflammatory drug (NSAID) indicated only for the short-term (10-days or less) management of acute pain and is not indicated for long-term use.

While not recommended, if a physician determines that the risk of longer use is justified by the potential benefit, the patient's transaminases (particularly ALT), and bilirubin, must be closely monitored for signs of hepatotoxicity.

Patients should be advised to take this medication as directed.

Please report all adverse events to Wyeth-Ayerst Laboratories Medical Information Department at 1-800-934-5556 or to the FDA MEDWATCH program at 1-800-FDA-1088 or by mail at the following address: MEDWATCH, HF-2, FDA, 5600 Fishers Lane, Rockville, MD. 20857.

Sincerely,

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

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