Duract™

Duract™, a non-steroidal anti-inflammatory drug (NSAID), was submitted to the Agency 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.

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.

Source: fda.gov

If you or a loved one has been harmed by Duract™, you may want to contact a Duract™ attorney for more information.