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| |  New Coumadin Package Insert Warns Against Duplicate Dosing WILMINGTON, DE -- June 10, 1998 -- DuPont Merck has added an important precaution statement to the package insert for its anticoagulant medication, Coumadin(R) (Warfarin Sodium Tablets, USP) Crystalline. The change follows reports of adverse events that may have resulted from patient confusion following changes in medication. Between two and three million elderly Americans are on Coumadin therapy. A generic warfarin has been available since 1997 and DuPont Merck has been tracking reports of patients who simultaneously took both the generic product and Coumadin following prescription refills. Because Coumadin and generic warfarin sodium have different shapes and tablet markings, there is the potential for patients to mistakenly take both products concomitantly, thus risking an increase in INR and possible hemorrhage. Under the Information for Patients section of Precautions in the Coumadin(R) package insert, a new sentence has been added: "Patients should be informed that all warfarin sodium, USP, products represent the same medication and should not be taken concomitantly, as overdosage may result." "Coumadin is a narrow therapeutic index drug, which means that there is a small difference between the amount needed to be effective in preventing strokes and related events and the amount which could cause internal bleeding and other complications," said Nick Teti, president of DuPont Merck's pharmaceuticals division. "Therefore, it is essential that patients do not take two doses of sodium warfarin at the same time unless advised by a physician." By law, generic warfarin must carry identical precautions as Coumadin in its labelling. Coumadin is indicated for prevention and treatment of venous thrombosis and for thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement, as well as to reduce the risk of death and other events after a first heart attack. The most common side effect and serious risk of oral anticoagulation therapy with Coumadin is bleeding in any tissue or organ. Numerous factors including travel, changes in diet, environment, general health, and medication may affect response to Coumadin. More information on: Coumadin, DuPont, Merck
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