DOCTOR'S VIEW ARCHIVE
WARNING from the FDA about Durat(Bromfenac)
The Food and Drug Administration (FDA) has received several
reports of serious effects on the liver (jaundice, severe
hepatitis, and life-threatening liver failure requiring
transplantation of the liver) among patients taking the
pain medication, bromfenac (Duract) for longer than 10
days. Duract is a relatively new drug approved by the FDA
in July of 1997.
In response, the FDA has requested that the pharmaceutical
manufacturer, Wyeth-Ayerst, send a letter to doctors
warning them about the risk to their patients.
Duract, a nonsteroidal anti-inflammatory drug (NSAID) is
related to ibuprofen (Motrin, Advil), naproxen (Naprosyn,
Aleve), and others. Liver problems with these related
drugs is unusual and rarely severe. Duract is available
only by prescription and is intended for the short-term
management of pain, for example, after surgery. It should
be used for 10 days or less.
Last Editorial Review: 2/23/1998