Pradaxa Death and Bleeding Risks


Pradaxa, the trade name of the drug Dabigatran, is an oralanticoagulant from the class of the direct thrombin inhibitors. It is used as an alternative to warfarin as an anticoagulant ("blood thinner"). It was developed by C.H. Boehringer Sohn AG & Ko. KG, a German pharmaceutical company. In December 2011, the U.S. Food & Drug Administration (FDA) initiated an investigation into serious bleeding events associated with dabigatran, stating, "[the] FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa [RE-LY trial]." In November 2011, the manufacturer of Pradaxa confirmed 260 fatal bleeding events worldwide between March 2008 and October 2011. Pradaxa is especially dangerous because while having the usual risks of other blood thinners, including excessive bleeding, there is no known reversal agent or antidote to Pradaxa and no standard model to measure the anticoagulant effects of Predaxa. If you have been given Pradaxa and would like more information please contact our office as soon as possible.

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