Bleeding Risk

• Warfarin sodium can cause major or fatal bleeding. Bleeding is more likely to occur during the starting period and with a higher dose (resulting in a higher INR).
• Risk factors for bleeding include high intensity of anticoagulation (INR greater than 4), age 65 or older, highly variable INRs, history of gastrointestinal bleeding, hypertension, cereberovascular disease, serious heart disease, anemia, malignancy, trauma, renal insufficiency, concomitant drugs (See PRECAUTIONS), and long duration of warfarin therapy.
• Regular monitoring of INR should be performed on all treated patients. Those at high risk of bleeding may benefit from more frequent INR monitoring, careful dose adjustment to desired INR, and a shorter duration of therapy.
• Patients should be instructed about prevention measures to minimize the risk of bleeding and to report immediately to physicians the signs and symptoms of bleeding (SEE PREACUTIONS:Information for Patients).