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.
Duract is prescribed to treat short-term pain associated with muscle aches, dental work, menstrual cramps and athletic injuries.
Duract was approved for use by the FDA in 1997 for the short-term management of acute pain.
Common side effects associated with Duract include nausea, dizziness, drowsiness, and blurred vision.
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.
Duract Drug is contraindicated in patients with any history of liver damage.
Why was Duract approved in the first place?
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 Bromfenac but am not taking it now. Should I still be concerned?
No. Serious liver problems have only occurred while taking Duract Bromfenac 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 suffered damages from taking Duract?
Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” 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 or a loved one has experienced any health problems while taking Duract, you should contact your doctor immediately. You may also wish to contact an experienced Duract lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.