DURACT

DURACT

What is Duract?

Duract is a nonsteroidal, anti-inflammatory analgesic indicated for short-term (10 days or less) management of pain. It is produced by the Wyeth-Ayerst Company.

FDA Warning:

Both the FDA an Wyeth-Ayerst closely watched the drug for safety issues and found rare but serious liver problems as people took the drug for extended periods of time. On February 6, 1998 warnings were issued to health care professionals about the new toxicity, medication labels were changed to reinforce safe use, and monitoring was increased.

Since that date, there were still further reports of cases involving severe liver damage. There have been 4 deaths, 8 patients that survived but required a liver transplant, and 12 other patients with serious but less severe liver damage. Based upon this new information and the conclusion that steps to limit use of the drug to just 10 days would not be practical or effective, the decision was made that the product should be withdraw.

What are the Side Effects?

Any liver problems would start to appear while taking this medication, or within several days of stopping. If you are experiencing any of the following, contact your healthcare provider immediately:

Pain on your right side, just below the ribs
yellowing of your skin or eyes
dark urine
nausea
vomiting
loss of appetite

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