E-DRUG: U.S. FDA Warning on Pain killer

[srahmad@essential.org]

E-DRUG: U.S. FDA Warning on Pain killer
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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 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, USA 

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