New Labeling Stresses Bleeding Risk from Coumadin Medical Video by Pharmacy

New Labeling Stresses Bleeding Risk from Coumadin

Pharmacy

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Description

A boxed warning has been added to the labeling for Coumadin (warfarin sodium) tablets and injection which reminds practitioners that patients may experience major or fatal bleeding from this drug. A new Medication Guide that instructs patients on precautions to be taken during treatment must also be distributed when prescriptions for Coumadin are dispensed. The new labeling for practitioners stresses that bleeding is more likely to occur when Coumadin therapy is being started, with higher doses, and with long periods of treatment. Other risk factors for bleeding include elevated or highly variable INR's, older age, a history of GI bleeding, hypertension, cerebrovascular disease, serious heart disease, anemia, malignancy, trauma or renal insufficiency, and taking concomitant drugs that may compromise clotting. The warning states that INR should be monitored regularly during treatment with Coumadin, and that patients judged to be at higher risk for bleeding may benefit from more frequent monitoring, careful dose adjustment, and a shorter duration of therapy. The Medication Guide alerts patients to warning signs of bleeding, instructs them to get regular tests for clotting, and lists the foods and drugs that may promote bleeding.