New York Duract Injury Attorneys

Duract, also known as bromfenac, is a non-steroidal anti-inflamatory painkiller used for short term, acute pain management. Manufactured by Wyeth-Ayerst Laboratories, it was approved and introduced to the U.S. in July 1997 and withdrawn from the market in 1998.

Duract, was approved by the FDA for short term (use for 10 days or less) management of acute pain. It was never approved as a treatment for longer term use for chronic conditions such as osteoarthritis or rheumatoid arthritis. After Duract was marketed, there were reports of cases of rare severe hepatitis and severe liver failure (some requiring transplantation) in patients taking the drug for more than 10 days.

The information about liver complications caused by elevated liver enzymes with extended use was included in the labeling. In February 1998 the labeling was revised with a special "Black Box" warning and a "Dear Doctor" letter re-emphasizing to health care professionals that the drug should not be prescribed for more than 10 days. The letter cited the incidents of hepatitis and liver failure suffered by patients using the drug for extended periods of time.

Despite these efforts, there were continued reports of severe injury and death due to long term use of Duract and Wyeth-Ayerst and the FDA withdrew the drug from the market. FDA is also advising patients to contact their doctors with any questions about use of the drug.