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Xeloda black box warning

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A Roche Xeloda labeling supplement, approved Sept. 7, adds a boxed warning on interaction with warfarin. The warning states that "altered coagulation parameters and/or bleeding, including death, have been reported in patients taking Xeloda concomitantly with coumarin-derivative anticoagulants." Physicians are advised that patients receiving Xeloda and warfarin should be monitored frequently
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