New Research Points to Potentially Fatal Risks of Pradaxa® Bleeding Complications
This month, two new studies evaluate the dangers of intracranial Pradaxa® brain hemorrhage among patients with closed head injuries. In the Journal of Neurosurgery report, researchers compared case studies among head trauma patients on Warfarin®, an older blood thinner, with patients on Pradaxa® and others who took no anticoagulants. The study included fifteen patients who had suffered closed head injuries. Those on Warfarin® recovered; however, of the five patients on Pradaxa®, two died from brain hemorrhaging that doctors could not control, due to the lack of a reversal agent. The other study in Neurosurgical Focus considered potential reversal agents for Pradaxa®. Researchers concluded that the sole method currently available to mitigate the drug’s blood thinning effects is to administer dialysis to cleanse the blood to remove all traces of Pradaxa® from the system.
Pradaxa® is an oral anticoagulant (blood thinner) launched by Boehringer Ingelheim in October 2010. In December 2011, the U.S. Food and Drug Administration (FDA) issued a Safety Announcement that is was evaluating post-marketing reports of serious – and even fatal – bleeding events in patients taking Pradaxa®.
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