WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Table of Contents
Close this folderRegulatory actions
View the documentAluminium in total parenteral nutrition - labelling requirements & warning
View the documentAstemizole - warning concerning cardiovascular adverse events
View the documentBromfenac - warning label: liver damage
View the documentCarbamazepine - warning concerning precipitation
View the documentChlormezanone - withdrawn
View the documentCounterfeit drugs - warning to the public
View the documentDietary supplement "Sleeping Buddha" - warning concerning estazolam content
View the documentFenfluramine - withdrawn
View the documentHuman dura mater (freeze-dried) - restrictive measures
View the documentIsotretinoin - psychiatric adverse effects
View the documentPyrithione zinc (Skin-CapR) - withdrawn
View the documentSertindole - approval application withdrawn
View the documentTerfenadine - additional drug interactions
View the documentTerfenadine - withdrawn following approval of fexofenadine
Open this folder and view contentsDrug surveillance
Open this folder and view contentsNew developments
View the documentRecent approvals
Open this folder and view contentsMedical devices
Open this folder and view contentsGeneral information
Open this folder and view contentsVeterinary medicine

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.

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