(1998; 18 pages)
Bromfenac - warning label: liver damage
United States of America. The Food and Drug Administration and the manufacturer have informed health professionals about a new boxed warning drawing attention to severe hepatic toxicity that has been added to the labelling of the nonsteroidal anti-inflammatory agent, bromfenac (DuractR: Wyeth-Ayerst, capsules). The warning advises doctors about the risks of using bromfenac for more than 10 days since this has resulted in the development of jaundice, fulminant hepatitis and liver failure requiring transplants. In addition, the warning in the product labelling has been updated to reflect the severe hepatotoxicity observed.
Bromfenac is specifically indicated for short-term management of acute pain (10 days or less), and is not labelled for long-term use in chronic conditions such as osteoarthritis or rheumatoid arthritis. The "Dear Doctor" letter sent by the manufacturer, Wyeth-Ayerst, alerted doctors to cases of severe hepatitis and liver failure (some requiring transplantation) in patients who had taken bromfenac for more than one month without liver enzyme monitoring. Although few such injuries have occurred to date, the actual incidence of these problems is unknown.
The FDA is advising that doctors who determine that use of bromfenac beyond 10 days is warranted must closely monitor patients for liver problems.
References: FDA Talk Paper T98-6 dated 10 February 1998.