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Dangerous Drugs - Do You Know About Pradaxa?
Pradaxa (dabigatran etexilate mesylate), a new oral anticoagulant, achieved Food & Drug Administration ("FDA") approval on October 19, 2010. One notable advantage of using Pradaxa to replace Warfarin to prevent clot formation is the elimination of INR testing in patients taking Pradaxa. INR is the acronym for International Normalized Ratio, which is used to monitor the effectiveness of anticoagulant such as warfarin.
The difference in the way Warfarin (Coumadin) and Pradaxa (dabigatran) act upon the body is significant.
If a patient taking Warfarin is, for example, in an automobile accident and requires emergent surgery, physicians can reverse the action of Warfarin by giving Vitamin K and/or packed red blood cells.
The same patient on Pradaxa in an auto accident can not have the effects of Pradaxa (dabigatran) reversed as easily or as controllable. Pradaxa has a half-life of 12 -- 14 hours and, so simply discontinuing it still places a patient in need of emergency surgery at high risk of uncontrollable bleeding.
Pradaxa has also been reported to cause internal bleeding without the emergent surgery problem. The bleeding can be serious, and sometimes leads to death. Boehringer Ingelheim, the manufacture of Pradaxa has acknowledged a link between Pradaxa and at least 260 deaths since 2010.
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