XELODA
Using Xeloda (capecitabine) concurrently with warfarin increases the risk of bleeding complications, according to postmarketing reports on Xeloda, which is indicated to treat colorectal and breast cancer. In response, the manufacturer, Roche, and the FDA have added a black box warning and strengthened the precautions section of the labeling for Xeloda.
Postmarketing reports have shown clinically significant increases in prothrombin time and the international normalized ratio in patients who were stabilized on anticoagulants at the time Xeloda was introduced. Bleeding events occurred within several days and up to several months after therapy with Xeloda was initiated and, in a few cases, within 1 month after it was stopped.
The black box warning states that patients receiving Xeloda concurrently with an oral coumarin-derivative anticoagulant should have their anticoagulant response monitored frequently and the anticoagulant dosage should be adjusted accordingly. Many patients taking Xeloda are already predisposed to coagulopathy because of their age (over 60) and their cancer diagnosis.
Copyright Springhouse Corporation Mar 2002
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