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             Broadcast Media:    301-827-3434
                              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 (See Below) 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: MedWatch (HF-2), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857

This is the retyped text of a letter from Wyeth-Ayerst Laboratories. Contact the company for a copy of any referenced enclosures.

February 1998

Dear Health Care Professional:

Recently cases of severe hepatitis and liver failure (some requiring transplantation), have Occurred in patients who were taking DURACT (bromfenac sodium capsules). Each of these patients had taken DURACT for more than one month without liver enzyme monitoring. Although only a few cases have occurred to date, the actual incidence of these events is unknown. While no definitive cause for the occurrence of these adverse hepatic events, or the role of DURACT has been established, these patients were all receiving DURACT. Some non-steroidal anti-inflammatory drugs are known to carry the risk of severe hepatotoxicity.

Based on this recent experience during marketed use, Wyeth-Ayerst Laboratories has revised the DURACT labeling to include the following boxed warning:

WARNINGS
Hepatic Effects
Severe hepatic reactions, including jaundice, potentially fatal fulminant hepatitis and liver failure (some requiring transplantation), have occurred in patients taking DURACT for longer than the recommended duration. DURACT is a nonsteroidal anti-inflammatory drug (NSAID) Indicated only for the short-term (10-days or less) management of acute pain and is not indicated for long-term use.

While not recommended, if a physician determines that the risk of longer use is justified by the potential benefit, the patient's transaminases (particularly ALT), and bilirubin, must be closely monitored for signs of hepatotoxicity.

Patients should be advised to take this medication as directed.

The Indications and Usage, Precautions, Adverse Reactions and Dosage and Administration sections of the labeling contain revisions consistent with the revised Warnings. Please review the enclosed REVISED PRESCRIBING INFORMATION in detail to ensure the appropriate use of DURACT.

Please report all adverse events to Wyeth-Ayerst Laboratories Medical Information Department at 1-800-934-5556 or to the FDA MEDWATCH program at 1-800-FDA-1088 or by mail at the following address: MEDWATCH, HF-2, FDA, 5600 Fishers Lane, Rockville, MD. 20857.

Sincerely,

Phillip J. de Vane, M.D.
Vice President Clinical Affairs
North American Medical Director

Wyeth-Ayerst Laboratories
3450 Baychester Avenue
Bronx, NY 10475-9967

Legal Notice

FDA TALK PAPER

WARNING LABEL CHANGES FOR PAIN RELIEVER DURACT

FDA
TALK PAPER