Duract (bromfenac)

Duract (bromfenac) is a non-steroidal anti-inflammatory drug (NSAID) used for short- term management of acute pain; i.e.10 days or less. Manufactured by Wyeth-Ayerst, Duract reduces pain and inflammation associated with a variety of injuries.

Why Prescribed

Duract is prescribed to treat short-term pain associated with muscle aches, dental work, menstrual cramps and athletic injuries.

^ Back To Top

FDA Approved Uses

Duract was approved for use by the FDA in 1997 for the short-term management of acute pain.

^ Back To Top

Side Effects

Common side effects associated with Duract include nausea, dizziness, drowsiness, and blurred vision.

^ Back To Top

Warnings and Alerts

In l998, in response to the reports of severe liver failure and transplants, the FDA and Wyeth-Ayerst strengthened the warnings in Duract's labeling with a special black box warning. 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 in patients who had taken Duract. Despite these efforts, the FDA and Wyeth-Ayerst continued to receive reports of severe injuries and death with long-term use of the drug. Given the availability of other therapies, the 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. Therefore, the company and the FDA agreed that it would be prudent to withdraw the drug from the market.

^ Back To Top

Drug Contraindications

Duract is contraindicated in patients with any history of liver damage.

^ Back To Top

FAQ's

Why was Duract approved in the first place? Why wasn’t this problem picked up during the trials of the drug prior to approval?

While there are many pain relievers, there is still a need for good medicines, and Duract was very effective in relieving pain. The safety profile of Duract was acceptable in testing before approval. No cases of serious liver injury were reported in pre-marketing clinical trials. There were some cases of liver enzyme elevations in patients treated for 30 days or longer, but these elevations resolved with discontinuation of therapy and patients did not experience any problems.

I have taken Duract but am not taking it now. Should I still be concerned?

No. Serious liver problems have only occurred while taking Duract or within several days after stopping. But if you have questions, you should contact your health care professional.

How do I know if Duract has caused me liver problems?

Any liver problems would start to appear while taking Duract or within several days of stopping. If you are experiencing any of the following, contact your health care professional immediately:

• Unusually dark urine
• Yellowing of the whites of the eyes
• Pain just below your ribs on the right side
• Nausea and vomiting
• Loss of appetite
• Yellowing of your skin

Can I file a lawsuit if I have been injured as the result of taking Duract?

Patients injured by unsafe products are ordinarily entitled to recover monetary damages for all losses and expenses suffered from use of the product. Depending upon the particular circumstances of your case, damages may include recovery for any of the following:

• Past and future medical expenses
• Past and future pain and suffering
• Lost wages
• Loss of future earning capacity
• Emotional distress

If you have been injured and/or have lost a loved one due to wrongful death from taking Duract, you have legal rights and should contact a qualified defective drug litigation attorney to discuss your legal claim. As all legal claims are subject to time limits, known as statute of limitations, you may risk forfeiture of your right to financial compensation if you delay.

^ Back To Top