E-DRUG: Painkiller withdrawn from the market

[srahmad@essential.org]

E-DRUG: Painkiller withdrawn from the market
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T98-36                        
June 22, 1998                                               
              WYETH-AYERST LABORATORIES ANNOUNCES 
            THE WITHDRAWAL OF DURACT FROM THE MARKET

Wyeth-Ayerst Laboratories of St. Davids, Pa. has announced that it is 
voluntarily withdrawing the analgesic, Duract(bromfenac) from the 
market. The action follows postmarketing reports of rare severe liver 
failure in patients in whom the drug was used for extended periods of 
time which was not in accordance with labeling instructions. The 
following may be used to respond to questions.

Duract, a non-steroidal anti-inflammatory drug (NSAID), was submitted 
to the Agency [U.S. Food and Drug Administration] in l994 and was 
approved in July l997 for short term management of acute pain (use for 
10 days or less). It was never approved as a treatment for longer term 
use for chronic conditions such as osteoarthritis or rheumatoid 
arthritis.

No cases of serious liver injury were reported in clinical trials, 
however, because there was a higher incidence of liver enzyme
elevations in patients treated long term in clinical trials, the 
product was approved for use for 10 days or less. The information
about the elevated liver enzymes was included in the product labeling.

After Duract was marketed, FDA and the company received reports of 
several cases of rare severe hepatitis and liver failure (some 
requiring transplantation) in patients taking the drug for more than 
10 days.

In February l998, in response to the reports of severe liver failure 
(and transplants), FDA and the company strengthened the warnings in 
Duract's labeling with a special black box warning and Wyeth-Ayerst 
issued a Dear Doctor letter. The revised label re-emphasized that 
patients should not take the drug for more than 10 days and alerted 
physicians and other health care professionals to the cases of severe 
hepatitis and liver failure (and cases in which patients required a 
transplant) in patients who had taken Duract.

Despite these efforts, the agency and the company continued to receive 
reports of severe injuries and death with long term use of Duract.

Given the availability of other therapies, FDA and Wyeth-Ayerst 
concluded that it would not be practical to implement the 
restrictions necessary to assure the safe use (less than 10 days) of 
Duract. The company and FDA agreed that it would be prudent to 
withdraw the drug from the market. Wyeth-Ayerst is advising doctors to 
discontinue prescribing and dispensing Duract immediately.

FDA is also advising patients to contact their doctors with any 
questions about use of the drug. Wyeth-Ayerst is providing the new 
information in a Dear Doctor letter to physicians, pharmacists, and 
health care professionals. Questions from patients or health care 
professionals about the withdrawal of Duract can be addressed to 
Wyeth-Ayerst's hotline at 1-800-281-9260.


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