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Maybe Pradaxa (dabigatran) does need blood monitoring after all
2.5 out of 5 stars The Effect of Dabigatran Plasma Concentrations and Patient Characteristics on the Frequency of Ischemic Stroke and Major Bleeding in Atrial Fibrillation Patients. Reilly PA et al. J Am Coll Cardiol 2014 Feb 4;63:321-8. Abstract A must-read article in yesterday’s New York Times described the internal battle at Boehringer Ingelheim, the maker of Pradaxa (dabiagtran etexilate), concerning the publication of this study. A major marketing point posited in favor of dabigatran over warfarin for the prevention of stroke in patients with atrial fibrillation was that it did not require monitoring with reg...
Source: The Poison Review - February 7, 2014 Category: Toxicology Authors: Leon Tags: Medical bleeding blood testing boehringer ingelheim dabigatran pradaxa stroke Source Type: news

New frontiers in anticoagulation: non vitamin-K oral anticoagulants in stroke prevention.
Authors: Arnao V, Riolo M, Tuttolomondo A, Pinto A, Fierro B, Aridon P Abstract INTRODUCTION: Non vitamin-K oral anticoagulants (NOACs) are direct and specific inhibitors of the coagulation factors IIa (dabigatran) and Xa (apixaban, rivaroxaban, edoxaban) which share many pharmacokinetic properties. However, indications are lacking regarding the use of NOACs during thrombolysis, surgery and bleeding events. Areas covered: In this paper, the authors retrospectively analyzed the relevant literature on the NOACs using the PubMed and Google Scholar databases. Expert Commentary: Although warfarin is effective in cardioembo...
Source: Expert Review of Neurotherapeutics - December 3, 2016 Category: Neurology Tags: Expert Rev Neurother Source Type: research

The acute management of haemorrhage, surgery and overdose in patients receiving dabigatran
Dabigatran is an oral direct thrombin inhibitor (DTI) licensed for stroke prevention in atrial fibrillation and likely to be soon approved in Europe for treatment of venous thrombosis. Predictable pharmacokinetics and a reduced risk of intracranial haemorrhage do not negate the potential risk of haemorrhage. Unlike warfarin, there is no reversal agent and measurement of the anticoagulant effect is not ‘routine’. The prothrombin time/international normalised ratio response to dabigatran is inconsistent and should not be measured when assessing a patient who is bleeding or needs emergency surgery. The activated p...
Source: Emergency Medicine Journal - January 15, 2014 Category: Emergency Medicine Authors: Alikhan, R., Rayment, R., Keeling, D., Baglin, T., Benson, G., Green, L., Marshall, S., Patel, R., Pavord, S., Rose, P., Tait, C. Tags: Poisoning/Injestion, Open access, Drugs: cardiovascular system, Stroke, Poisoning Review Source Type: research

Resolution of left ventricular thrombus by edoxaban after failed treatment with warfarin overdose: A case report
Rationale: Although novel oral-anticoagulants are widely used in patients with atrial fibrillation (AF) for stroke prevention, there was only limited evidence for their use in left ventricular (LV) thrombus. Patient concerns: A 41-year-old man who presented with acute onset of right-hand clumsiness and aphasia even under high international normalized ratio (INR: 7.64) from warfarin use. He was previously treated with warfarin for the LV thrombus and non-valvular AF. Brain magnetic resonance imaging (MRI) showed multiple acute infarction in the cortex of the bilateral frontal lobes, left parietal lobe, and bilateral ce...
Source: Medicine - January 1, 2019 Category: Internal Medicine Tags: Research Article: Clinical Case Report Source Type: research

Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) Versus Warfarin in Patients with Atrial Fibrillation and (Morbid) Obesity or Low Body Weight: a Systematic Review and Meta-Analysis
ConclusionThe benefit-risk profile of NOACs seems preserved in (morbidly) obese AF patients and patients with low body weight. However, more data are needed on underweight AF patients (BMI<  18.5 kg/m2) and on differences between NOACs in these patients.
Source: Cardiovascular Drugs and Therapy - January 11, 2021 Category: Cardiology Source Type: research

Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System
Conclusion: Our findings describe the most reported risk factors for preventability of oral anticoagulant-induced bleedings. These factors may be useful for targeting interventions to improve pharmacovigilance activities in our regional territory and to reduce the burden of medication errors and inappropriate prescription. Introduction Oral anticoagulant therapy is widely used for the prevention of stroke and systemic embolism in patients with atrial fibrillation, or for the prevention and treatment of deep vein thrombosis and pulmonary embolism (Raj et al., 1994; Monaco et al., 2017). Oral anticoagulants can be di...
Source: Frontiers in Pharmacology - April 29, 2019 Category: Drugs & Pharmacology Source Type: research

Dabigatran, a Cause of Hematologic Emergency.
Abstract ABSTRACT:: Dabigatran etexilate, a direct thrombin inhibitor, has become an alternative to warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. There remains a concern about its overdose and life-threatening hemorrhage because of unavailability of appropriate coagulation tests to monitor and antidotes to reverse its effects. There are no clinical data about its safety in patients with fluctuating renal function. Multiple bleeding events reported with dabigatran have prompted the U.S. Food and Drug Administration to further investigate these reports. Four clinical cases with lif...
Source: The American Journal of the Medical Sciences - December 5, 2012 Category: Journals (General) Authors: Lal Y, Van Heukelom J Tags: Am J Med Sci Source Type: research

Case report: hemodialysis for dabigatran overdose
3 out of 5 stars Hemodialysis for the Treatment of Pulmonary Hemorrhage from Dabigatran Overdose. Chen BC et al. Am J Kidney Dis 2013 Apr 15 [Epub ahead of print] Abstract Dabigatran (Pradaxa) is a competitive direct thrombin inhibitor approved in the United States for stroke prophylaxis in patients with nonvalvular atrial fibrillation. Although dabigatran has certain advantages over coumadin related to issues of dosing and testing, there is no readily available test to measure its anticoagulation effect, and there is no antidote to reverse bleeding. Recommendations for treating a patient with dabigatran-associated hemorr...
Source: The Poison Review - April 24, 2013 Category: Toxicology Authors: Leon Tags: Medical dabigatran hemodialysis hemorrhage overdose Source Type: news

Managing Bleeding in Anticoagulated Patients in the Emergency Care Setting
Conclusions: The introduction of alternative oral anticoagulants will require emergency procedures that differ in some respects from those currently in place for warfarin and it will be necessary for Emergency Medicine professionals to become familiar with these procedures. Clinical stabilization of the bleeding or at-risk patient remains the emergency physician’s priority.
Source: The Journal of Emergency Medicine - June 19, 2013 Category: Emergency Medicine Authors: Charles V. Pollack Tags: Clinical Reviews Source Type: research

Dabigatran overdose: case report of laboratory coagulation parameters and hemodialysis of an 85-year-old man
Dabigatran is an oral direct inhibitor indicated for stroke prevention in patients with atrial fibrillation. Unlike warfarin, dabigatran's observed therapeutic window and minimal drug-to-drug interaction suggest that laboratory test and dose adjustments are not necessary; nevertheless, circumstances of excessive anticoagulation, decreased kidney function, and instances of significant bleeding and thrombosis require laboratory assessment. In order to gather experience in the management of global [activated partial thromboplastin time (APTT) and thrombin time (TT) with extended endpoint] and specific [ecarin chromogenic assa...
Source: Blood Coagulation and Fibrinolysis - January 30, 2015 Category: Hematology Tags: Case Reports Source Type: research

Management of dabigatran-induced bleeding with continuous venovenous hemodialysis.
Abstract Dabigatran, a direct thrombin inhibitor, is increasingly used for stroke prevention in patients with non-valvular atrial fibrillation. Dabigatran has a stable pharmacokinetic profile with minimum drug interactions, and requires no routine laboratory evaluation to measure level of anticoagulation. This provides a huge advantage over warfarin, and has the potential to improve patient compliance. The disadvantages of dabigatran are the lack of a reversal agent to counter dabigatran-related bleeding and the absence of a widely available laboratory test that can quantify the extent of coagulopathy in dabigatr...
Source: International Journal of Hematology - January 30, 2015 Category: Hematology Authors: Paul S, Hamouda D, Prashar R, Mbaso C, Khan A, Ali A, Shah S, Assaly R Tags: Int J Hematol Source Type: research

Evaluating coagulation tests in patients with atrial fibrillation using direct oral anticoagulants.
Authors: Chan NC, Bhagirath V, Dale BJ, Eikelboom JW Abstract Four direct oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban) have been shown to be at least as effective and safe as warfarin for the prevention of stroke in atrial fibrillation and the prevention and treatment of venous thromboembolism. Although they are administered in fixed doses without routine coagulation monitoring, measurement of anticoagulant effect or drug levels may be useful to determine if: anticoagulant effect is present in patients who are bleeding or require an urgent procedure or thrombolysis; levels are within usual on-t...
Source: Expert Review of Cardiovascular Therapy - February 17, 2016 Category: Cardiology Tags: Expert Rev Cardiovasc Ther Source Type: research

Intravenous Fat Emulsion Does Not Significantly Alter Clotting Markers in Dabigatran-Treated Blood
AbstractDabigatran etexilate is an oral direct thrombin (Factor IIa) inhibitor approved for patients with atrial fibrillation and for management of risk of deep vein thrombosis and pulmonary embolism. Dabigatran offers advantages over treatment with warfarin, including limited laboratory monitoring. It is equivalent in prevention of stroke and deep vein thrombosis with essentially equivalent complication rates. In contrast to warfarin, reversal of the anticoagulation is less well established. Idarucizumab is available for reversal, however supporting research is mixed; the agent also happens to be quite expensive making av...
Source: Indian Journal of Hematology and Blood Transfusion - June 21, 2020 Category: Hematology Source Type: research