Clotblog with Dr Samuel Goldhaber

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FDA advisory exonerates dabigatran (Pradaxa) on serious bleeding relative to warfarin

Nov 30, 2012 00:00 EST


The recent FDA drug safety communication exonerates dabigatran by its finding in a postmarket review that serious bleeding with new use of the drug does not appear to be higher than serious bleeding associated with new use of warfarin.

See:

Pradaxa (dabigatran etexilate mesylate): Drug safety communication—Safety review of postmarket reports of serious bleeding events









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Who's Talking
Samuel Z Goldhaber, MD
Professor of Medicine
Harvard Medical School
Director, Venous Thromboembolism Research Group
Co-Director, Anticoagulation Management Service
Cardiovascular Division
Brigham and Women's Hospital
Boston, MA