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