All bleeding stops — but does idarucizumab (Praxbind) make it stop faster?

3.5 out of 5 stars Persistent life-threatening hemorrhage after administration of idarucizumab. Alhashem HM et al. Am J Emerg Med 2016 June 30 [Epub ahead of print] Reference Dabigatran (Pradaxa) is a direct thrombin inhibitor approved for stroke and embolism prophylaxis in patients with non-valve-related atrial fibrillation. When it was first released in 2008, a major disincentive to widespread use was the lack of a reliable reversal agent to treat major bleeds, or to administer before necessary invasive procedures. In October 2015, the U.S. Food and Drug Administration approved idarucizumab (Praxbind), a monoclonal antibody that avidly binds to dabigatran. under its accelerated approval program. As described by an FDA release, this program: . . . allowed drugs for serious conditions that filled an unmet medical need to be approved base on a surrogate endpoint.” In the case of idarucizumab, the surrogate end-points involved normalization of laboratory parameters of anticoagulation. As far as I can determine, there have been no studies that demonstrate convincingly any clinical patient-oriented benefit. In fact, in the major study addressing this issue,  it took a median of 11.4 hours to restore hemostatis after administration of idarucizumab. There was not control group, so we have no idea if this is better than simple watchful waiting. Clearly, it seems far too long to be useful in true life-threatening hemorrhage. This case report illustrates the point. A 65-year-...
Source: The Poison Review - Category: Toxicology Authors: Tags: Medical anticoagulant hemorrhage idarucizumab pradaxa praxbind reversal agent Source Type: news