FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T98-6                         Print Media:        301-827-6242
February 10, 1998             
                              Consumer Inquiries: 800-532-4440

WARNING LABEL CHANGES FOR PAIN RELIEVER DURACT

FDA and Wyeth-Ayerst Laboratories are telling doctors about a new boxed warning in the labeling of the drug, Duract (bromfenac sodium capsules), a short-term treatment for managing pain. Use of Duract for more than 10 days can cause serious liver damage. Patients using Duract for more than 10 days have developed jaundice, fulminant hepatitis, and liver failure requiring transplants.

Duract is specifically indicated for short-term management of acute pain (use for 10 days or less), and is not labeled for long-term use in chronic conditions such as osteoarthritis or rheumatoid arthritis. The following may be used to respond to questions.

In a "Dear Doctor" letter sent by the manufacturer, Wyeth-Ayerst of Philadelphia, PA, doctors are being alerted to cases of severe hepatitis and liver failure (some requiring transplantation) in patients who had taken Duract for more than one month without liver enzyme monitoring. Although a few such injuries have occurred to date, the actual incidence of this problem is unknown.

FDA is advising that doctors who determine that use of Duract beyond 10 days is warranted must closely monitor patients for liver problems.

To provide additional information on the safe use of these drugs, FDA has requested that the manufacturer add a boxed warning to the labeling advising doctors about the risks and emphasizing that the drug is indicated for use for 10 days or less. The new labeling information recommends that patients should be advised to take Duract (strictly) as directed. The warning in the product labeling has been update to reflect the severe hepatotoxicity observed.

Health care providers should report any adverse events related to Duract to Wyeth-Ayerst Laboratories (1-800-934-5556), or to FDA. Reports may be submitted to FDA by telephone (800-332-1088), by fax 800-332-0178), or by mail using a postage paid MedWatch form from the back of the Physicians Desk Reference. The Medwatch report should be mailed to: