Duract is an anti-inflammatory drug used for the short-term treatment of acute pain. The FDA approved the drug for this use in 1997. There were later reports of the drug causing severe liver failure in patients who used the drug for longer than 10 days. It was after these reports that Wyeth-Ayerst Laboratories decided to withdraw the drug from the market.
The side effects of both liver failure and hepatitis were not discovered during the clinical trials because they never treated patients with Duract for more than 10 days, although they did notice liver enzyme elevations in long-term patients. The original packaging for Duract contained a warning label noting the elevations in the liver enzyme. After the drug was put onto the market it was inappropriately used to treat pain associated with chronic conditions such as rheumatoid arthritis.
Patients who have used Duract in the past do not need to be worried about contracting liver disease at the present time. Symptoms of liver failure will only occur while taking the drug or several days after stopping. Symptoms that relate to liver disease include dark urine, pain below the ribs, nausea and vomiting, and yellowing in the eyes.
After initial reports of liver failure came in, Wyeth-Ayerst Laboratories repackaged the drug and created a warning label that warned patients against taking the drug for more than 10 days as it may result in liver failure. The company also wrote a Dear-Doctor letter clearly stating the complications that may arise from long-term use of Duract.
They also alerted health care professional of the long-term risks of Duract. Despite all of these efforts, reports continued to come in that there had been severe injury and death from long-term use of the drug. After these repeated incidents it was decided between Wyeth-Ayerst Laboratories and the FDA to discontinue use of the drug due to the unnecessary risk involved with taking the drug long-term.
Doctors were then advised to stop prescribing the drug immediately and suggest the use of alternatives instead. If a patient is continuing to use Duract or has any questions about the possible side effects they should contact their physician to answer any questions they may have.
Make sure that if you or someone you love was injured by Duract that you contact a lawyer immediately. You may be able to collect financial restitution for your pain and suffering, but statute of limitation laws in your state restrict the amount of time you have to take action. Do not delay any longer. Consult a Duract attorney today.