Friday 1 August 2008

What is coumadin

Coumadin is a widely prescribed blood thinner. At the request of the Food and Drug Administration (FDA), Bristol-Myers Squibb has strengthened its US label for warfarin (Coumadin) to include a black-box warning about the risk for major or fatal bleeding. It says that bleeding is more likely to occur during the starting period. Among others, the risk factors for bleeding include trauma, anemia and concomitant drugs

Coumadin label also reads that Coumadin is contraindicated with recent traumatic surgery resulting in large open surfaces. Potential adverse reactions to COUMADIN may include: Fatal or nonfatal hemorrhage from any tissue or organ. This is a consequence of the anticoagulant effect. Therefore, the possibility of hemorrhage should be considered in evaluating the condition of any anticoagulated patient with complaints which do not indicate an obvious diagnosis. (Source: http://www.fda.gov/medwatch/safety/2006/coumadin_PI_april2006.pdf)

And yet I was given Coumadin following recent abdominal surgery (C section), in absence of any symptoms and inconclusive CT scan reports. And these were continued for next 5 days in spite of my repeated denial of all symptoms, bleeding from surgical site, drainage from c section incision, increasing anemia in spite of thrice a day oral iron, increasing WBC count on antibiotics, fever and complete wound separation.

The FDA Med watch announcement also notes that Coumadin prescriptions will also be issued with a new patient medication guide warning about potentially serious bleeding with the drug. FDA regulations state that such medication guides are to be provided with each prescription that is dispensed for products that the FDA determines pose a serious and significant public health concern. I was also not made aware of the possibility of bleeding on Coumadin.

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