“And finding information about reversing anticoagulation is not a quick and easy thing to do.” “We decided to go ahead and address all the agents, including the new ones, because when someone comes in in the middle of the night with bleeding, the experts are not always available,” Dr. One year in the making, the guidelines resulted from a collaboration of many specialties and were put in place last July. Hospitalists are also trying to figure out what to do with anticoagulation on discharge if they are worried about patients continuing on one of the newer agents.Īt Henry Ford Hospital in Detroit, a multidisciplinary team came up with what James Kalus, PharmD, calls a “one-stop shop” in terms of in-house guidelines for anticoagulation management. Patients with poor kidney function “including some who never should have been prescribed the medications in the first place “are showing up at the hospital on these drugs, presenting management challenges for hospitalists because the drugs have to be cleared by the kidneys.Īnd given everyone’s limited experience with the newer agents, perioperative and postoperative management concerns are emerging. Catastrophic bleeds are occurring, often with little warning. Now that rivaroxaban has also been approved for both DVT/PE prevention and treatment, the drug is increasingly being prescribed to inpatients.īut while these drugs offer some advantages over warfarin, including far fewer drug-drug interactions, hospitalists are finding that they’re anything but hassle-free. The fact that both patients and primary care physicians heard that message loud and clear contributed to dabigatran, in particular, gaining ground in the outpatient setting. When these newer agents hit the market, they were touted as low-hassle, lower-risk alternatives to warfarin for patients with atrial fibrillation, offering an end to pesky INR monitoring and wide, worrisome swings in drug levels. We’re relying on case reports.”Īlthough this is hardly the first time that drugs without an antidote have made their way into common use, the situation with dabigatran and rivaroxaban is catching many institutions off guard. “That’s what tells you that you have the right antidote, and we don’t have that kind of information yet for these medications. “The gold standard would be giving a bleeding patient a product that not only reverses the results on lab tests, but stops the bleeding,” Dr. Instead, he says, they must take a wait-and-see approach. The few studies we do have were done on normal volunteers.”Ĭompounding that problem, physicians don’t have any good lab test to indicate if the reversal strategy is stopping the bleeding. Streiff readily admits that these reversal strategies “are imperfect to a large degree, and there’s very little experience in humans. “If someone comes in bleeding, you give products that can potentially increase the amount of thrombin or factor Xa to bind up the drug and reverse the anticoagulant activity.”īut Dr. Some reversal protocols now add in charcoal and hemodialysis in last-ditch emergencies, at least for bleeds involving dabigatran. And multidisciplinary task forces are coming up with their own in-house protocols for reversal strategies that include the use of blood products: prothrombin complex concentrates (PCCs) like Bebulin and blood factors like recombinant factor VIIa and factor VIII inhibitor bypass activity agent (FEIBA). In the absence of formal guidance, hospitals are combing through those case reports, looking at the (very sparse) literature on how to try to manage bleeding in patients taking the newer agents. “That, understandably, makes doctors uncomfortable.” That’s particularly true as case reports of catastrophic bleeds make their way into the literature or crop up in institutions. “There is no evidence-based antidote or reversal strategy for these drugs,” says Michael Streiff, MD, medical director of the Johns Hopkins anticoagulation management service in Baltimore. If the culprit is warfarin or heparin, doctors can rely on tried-and-true reversal strategies and antidotes: vitamin K, recombinant factor VII, and maybe fresh frozen plasma (FFP) for warfarin and aggressive protamine dosing for heparin.īut that’s far from the case if the bleeding is associated with dabigatran, the new, oral direct thrombin inhibitor, rivaroxaban or the very recently approved apixaban, both factor Xa inhibitors. IT’S ALWAYS A CHALLENGE when an anticoagulated patient is admitted to the hospital with a serious bleed or develops one in-house. Published in the May 2013 issue of Today’s Hospitalist
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