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Pradaxa is excreted through the kidneys, thus impaired kidney function could lead to abnormally high levels of the drug in circulation, leading to excessive Pradaxa internal bleeding. Unlike warfarin, there is no antidote for Pradaxa internal hemorrhaging. A Clinical trial (RE-LY) found that up to 16.4% of Pradaxa users may experience internal hemorrhaging.
Pradaxa (dabigatran) was released in October 2010 as an anticoagulant, but received more consumer complaints to the FDA’s MedWatch adverse event reporting system in its first three months on the market than 98.7% of the other drugs.
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