I saw a patient on the Big Island of Hawaii with serious intracranial bleeding on Pradaxa. Now it’s rural here, which means a dearth of specialty care. And so three months ago when his brilliant doctor in a major city on the mainland, switched him to Pradaxa for his atrial fibrillation (so he wouldn’t have to check his INR while he got settled comfortably into his retirement in Hawaii) his fate was sealed. He arrived at the nearest hospital to him which had no intervention other than Vitamin K. No platelets, no FFP, no neurosurgeon. Rapid diagnosis and a flight to Oahu for neuro/icu care was still meant several hours of continued bleeding. Things did not go well for him.
After I got home that night I watched the news about BP settling its federal lawsuit and I thought, what do the Deepwater Horizon disaster and Pradaxa have in common? It seems obvious that any endeavor with a potential for serious risk should have a clear plan to deal with the most likely adverse outcome(s). In the case of offshore drilling, you shouldn’t be looking for oil at 1800 feet below seal level if you don’t have a viable plan to contain an oil spill. In the case of Pradaxa, you shouldn’t be giving anticoagulants to patients if you don’t have a viable plan for the most likely adverse outcome, bleeding. It’s really just asking for trouble.
To highlight this problem, the management of an overdose with the new oral anticoagulants was recently published and then discussed on one of my favorite blogs, The Poison Review, and the most notable revelation about these collaborative guidelines is that the best option ten organizations who focus on thrombosis and anticoagulation could come up with was, wait for it, wait for it….SUPPORTIVE CARE.
I understand that anticoagulation in certain patients is a valuable tool. But we all know the rapid spread of highly marketed medications to questionable patient populations is a given, and we already have an effective anticoagulant, it’s called Coumadin. Coumadin is far from perfect and the search for safer, more user-friendly medications is a worthwhile endeavor, but let’s be honest, we’re still far from a perfect solution.
Is Pradaxa safer? Did it show benefit over Coumadin? No. But when you watch the ads for Pradaxa it sounds like huge benefit. Of course the fine print is that the benefit was found in patients with sub-therapeutic INR. Maybe it’s not as “convenient” as the newer drugs, but even with reversal agents this medication causes a lot of morbidity, hospitalization, and death. So please explain to me how an expensive drug gets mass marketed before there is a way to appropriately treat the potentially fatal side effects when there is an equally effective drug we can reverse? Never mind, I know the answer…
(As always, a collection of emergency medicine focused resources for our topic)
Guidelines for reversing overdose of dabigatran (Pradaxa) and other new anticoagulants
Anti-coagulated Patients In The ED – LITFL
Dabigatran (Pradaxa®) Principles and Guidance for the Reversal of Effect and Management of Life Threatening or Major Bleeding
Paucis Verbis: Overanticoagulation and supratherapeutic INR
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