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Pradaxa Death Blamed On Irreversible Bleeding

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At least one Pradaxa death is being blamed on irreversible bleeding. Pradaxa (dabigatran), approved by the U.S. Food & Drug Administration (FDA) October 2012, is prescribed as a blood thinner for patients diagnosed with atrial fibrillation to prevent stroke. Although both Pradaxa and warfarin—known by the brand name Coumadin, which has been marketed for decades—pose risks for serious bleeding. Where warfarin’s bleeding side effect can be contained, Pradaxa’s cannot: There is no reasonable antidote for Pradaxa bleeding, noted NewsInferno; however, Pradaxa is touted as a better alternative to warfarin. In one such bleeding case, said The Houston Press, one woman died within 24 hours of a fall that involved a blow to her head. Loraine Franklin, 80, suffered an intracranial hemorrhage that the hospital’s physicians were unable to stop. Sadly, all her team could do was ensure Franklin’s comfort and stand by as her speech blurred, blood flooded her skull, and she died. In warfarin bleeds, out-of-control bleeding is typically resolved with vitamin K; fresh, frozen plasma; or prothrombin complex concentrates (PCCs). Early Pradaxa bleeds—but, very early—can be resolved with medication cessation and dialysis, noted The Houston Press. When a Pradaxa bleed is not caught extremely early, no effective reversal agent exists to stop the traumatic bleeds. Franklin’s daughters are suing Boehringer Ingelheim, Pradaxa’s manufacturer, for not sufficiently warning doctors and patients that Pradaxa has no effective antidote. Franklin’s daughters are just two of many others who have been filed Pradaxa lawsuits. As NewsInferno recently noted, Boehringer Ingelheim acknowledged that, since March 2008, it had received 260 reports of Pradaxa bleeding-related deaths. Last month, the Institute for Safe Medicine Practices (ISMP) reported that Pradaxa was linked to 856 reports of serious, disabling, or fatal injury—117 of these, bleeding deaths—in 2011’s second quarter alone, said NewsInferno. And, in a prior report, ISMP said more than 500 serious Pradaxa bleeding cases were reported to the FDA in first-quarter, 2011. Although the FDA initiated a Pradaxa review in December over reports of bleeding-related side effects, and European and Japanese regulators have directed Boehringer Ingelheim to increase Pradaxa warnings, the FDA announced that it “continues to believe that Pradaxa provides an important health benefit when used as directed,” said The Houston Press. Boehringer told the Houston Press that 260 recorded deaths are not outside the parameters of the major clinical trial used for Pradaxa’s approval. Houston trauma surgeon, Bryan Cotton, associate professor of surgery at the University of Texas Medical School at Houston and a physician-scientist in coagulation research at the Center for Translational Injury Researchmind, along with two colleagues, wrote to the editor of The New England Journal of Medicine in November 2011. In that letter outlining his experience with patients on Pradaxa (dabigatran), the three wrote, “Currently, the only reversal option for dabigatran is emergency dialysis (as suggested in a single line in the package insert) …. The ability to perform rapid dialysis in patients with bleeding whose condition is unstable or in those with large intracranial

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hemorrhages will present an incredible challenge, even at level 1 trauma centers,” according to The Houston Press. The group noted that Pradaxa bleeding is “… irreversible—that’s a great idea; a drug that makes you bleed to death and there’s no reversal agent…. When prescribing a drug with side effects that include life-threatening hemorrhage, reversal is not ‘desirable,’ it is essential.”

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