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American Journal of Medicine
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American Journal of Medicine
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Many of these NOACs have just been introduced into clinical practice. We have the most clinical experience with dabigatran, where reports of real-world or real-life experiences are just beginning to appear. For example, the Mini-Sentinal project run by the US Food and Drug Administration (FDA) nicely demonstrated that for the combined incidence of intracranial and gastrointestinal hemorrhage per 100,000 days, the risk was higher with new users of warfarin compared with new users of dabigatran.[21] The concerns that there may be more bleeding with this NOAC are clearly dispelled by this kind of real world data. Camm J. Am J Med 2013; published on-line at http://education.amjmed.com/00000.
[21] U.S. Food and Drug Administration (FDA). FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran). Silver Spring, MD: U.S. Food and Drug Administration; November 2, 2012. http://www.fda.gov/Drugs/DrugSafety/ucm326580.htm