Questions and Answers for Withdrawal of Duract
Internet URL
http://www.fda.gov/cder/news/duract/qa.htm
Sponsoring Agency
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Description
Answers to consumers' questions concerning the withdrawal of Duract from the market and FDA's recommendation that patients stop taking the drug after reports of a rare but serious liver problem as more people took Duract for extended periods of time beyond that recommended in the labeling. Duract was originally approved with labeling that described this potential for elevated liver enzymes and limited product use to 10 days or less for management of acute pain.
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