WASHINGTON (Reuters Health) -A black box warning has been added to the label of Hoffman-La Roche's cancer treatment Xeloda (capecitabine) to strengthen a warning regarding a possible interaction with Dupont Pharmaceuticals' anticoagulant Coumadin (warfarin), the US Food and Drug Administration (FDA) said on Thursday.
Based on post-marketing studies, "patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly," the FDA said.
Xeloda's patient package insert has also been updated to reflect the agency's concerns.
The FDA first approved Xeloda in May for the treatment of colorectal cancer. In September, it was also approved for treatment of breast cancer in combination with Aventis Pharmaceuticals' Taxotere (docetaxel).
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