News Briefs: Black-box warning added to Xeloda label

The Food and Drug Administration and Roche have added a black-box warning and strengthened the precautions section in the label for capecitabine (Xeloda), indicated for the treatment of colorectal and breast cancer. A clinically important Xeloda-Warfarin drug interaction was demonstrated in a clinical pharmacology trial. Postmarketing reports have shown clinically significant increases in prothrombin time and international normalizing ratio (INR) in patients who were stabilized on anticoagulants at the time Xeloda was introduced. Patients receiving concomitant capecitabine and oral, coumarin-derivative, anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently to adjust the anticoagulant dose accordingly. The Patient Package Insert also was revised to reflect this new safety information. For more information, see www.fda.gov/medwatch/safety/2001/safety01.htm.