Praxbind (idarucizumab) / Boehringer Ingelheim - LARVOL DELTA

Thrombotic and ischemic event reporting with anticoagulant reversal agents: a multi-agent FAERS pharmacovigilance study. (PubMed, J Thromb Thrombolysis) - "We evaluated thrombotic and ischemic adverse-event reporting for andexanet alfa, idarucizumab, and a prothrombin complex concentrate (PCC) exposure set in the FDA Adverse Event Reporting System (FAERS). FAERS reports showed disproportionate thrombotic and ischemic reporting for all three reversal-agent exposure sets, with a prominent andexanet signal for ischemic stroke. These findings are hypothesis-generating and should not be interpreted as incidence, causality, or a direct comparative clinical-risk estimate."

Adverse events • Journal • Cardiovascular • Hematological Disorders • Ischemic stroke • Thrombosis

Safety and efficacy of idarucizumab-assisted thrombolysis in dabigatran-related acute ischemic stroke: a systematic review and single-arm meta-analysis. (PubMed, Front Neurol) - "However, these findings provide useful effect-size estimates (sICH ~5%, good outcome ~67%) for designing future randomised controlled trials. Multicenter prospective registries or pragmatic RCTs are warranted."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Intravenous thrombolysis in acute ischemic stroke after recent direct oral anticoagulant intake: toward evidence-informed care. (PubMed, Front Neurol) - "We argue that contemporary evidence supports reconsideration of rigid time-based exclusion criteria in favor of more individualized, evidence-informed decision-making. Although important uncertainties remain, recent DOAC exposure may not necessarily preclude IVT in appropriately selected patients, particularly when anticoagulant activity can be reliably assessed."

Journal • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Brazilian consensus on the management of bleeding complications related to the use of oral anticoagulants. (PubMed, Rev Assoc Med Bras (1992)) - "Management of bleeding in patients receiving oral anticoagulants requires rapid clinical assessment, severity stratification, targeted reversal strategies, and multidisciplinary care. Individualized reassessment of thrombotic versus hemorrhagic risk is essential to optimize outcomes and guide safe reintroduction of anticoagulation therapy after bleeding resolution."

Clinical guideline • Journal • Cardiovascular • Hematological Disorders • Thrombosis

Nanotechnology - Driven Innovations in Anticoagulant Delivery and Antidote Development for Hemostasis Regulation. (PubMed, Cardiovasc Hematol Disord Drug Targets) - "This review highlights the novelty of integrating nanotechnology-based delivery systems with targeted antidote strategies. Such convergence offers a patient-centred, safer, and more effective framework for anticoagulant therapy, while underscoring the need for future research in clinical translation, cost-effectiveness, and long-term safety."

Journal • Cardiovascular • Venous Thromboembolism

From empirical hemostasis to precision reversal: clinical challenges, technological innovations, and individualized strategies in anticoagulant-associated bleeding. (PubMed, Front Cardiovasc Med) - "While specific reversal agents (e.g., idarucizumab, andexanet alfa) have inaugurated an era of targeted precision reversal through high-affinity molecular neutralization, their widespread application is frequently hampered by exorbitant pharmacoeconomic costs, limited accessibility, and latent prothrombotic "off-target" effects (e.g., TFPI inhibition)...To circumvent existing limitations, current technological trajectories are pivoting towards the rational design of broad-spectrum synthetic molecules (e.g., ciraparantag) and highly programmable nucleic acid aptamer systems...We propose a multidimensional framework driven by point-of-care (POC) viscoelastic testing, algorithmic clinical decision support systems, and sequential therapy pathways managed by multidisciplinary "Code Bleed" teams. Future research must urgently prioritize large-scale, head-to-head randomized trials focused on patient-centered hard endpoints, ultimately refining evidence-based..."

Journal • Review • Cardiovascular • Hematological Disorders

Aftercare Following Major Anticoagulant-Related Bleeding: A Review of Reversal Agent Recipients at a Tertiary Care Center (ISTH 2026) - "Patients receiving anticoagulant reversal therapy—prothrombin complex concentrate (PCC), andexanet alfa, or Idarucizumab—for major bleeding were identified through prescription records. a In those patients who had the risk factor. DOI*10.1016/j.rpth.2026.105373"

Review • Gastroenterology

Idarucizumab for Dabigatran Reversal: A 10-Year Single-Centre Experience (EAN 2026) - No abstract available

Clinical

USAGE OF POINT-OF-CARE DIRECT ORAL ANTICOAGULANT URINE DIPSTICK ASSAY IN AN AUSTRALIAN STATE-WIDE ACUTE TELE-STROKE SERVICE. (EHA 2026) - "This guidance stems from historical data demonstrating increased rates of thrombolysis-related cerebral haemorrhage in patients on warfarin...A point of care (POC) urine DOAC assay (validated to correlate with serum levels below 30ng/mL for dabigatran, apixaban and rivaroxaban) was rolled out in July 2025...Two were on dabigatran with one receiving idarucizumab prior to thrombolysis...The POC assay was used in fewer than half the hospitals, yet two patients with negative results received thrombolysis, supporting potential clinical value. Increased awareness and education on the utility of the POC assay in acute stroke within the VST network is required."

Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Ischemic stroke • Migraine

A UK-wide analysis of the use of reversal agents in 198 patients on direct oral anticoagulants prior to urgent procedures. (PubMed, Res Pract Thromb Haemost) - "We conducted a UK-wide audit of adults receiving andexanet alfa, idarucizumab, or 4F-PCC to reverse apixaban, dabigatran, edoxaban, or rivaroxaban, before urgent procedures between October 2020 and June 2023. There is limited evidence to support the off-label use of 4F-PCC; the risks, benefits, and cost effectiveness are uncertain. Delays to intervention, low use of tranexamic acid, and infrequent drug-level testing highlight opportunities to improve clinical workflows and inform future trials."

Journal • Cardiovascular • Hematological Disorders • Thrombosis

Antidotes for Anticoagulation Reversal. (PubMed, N Engl J Med) - "Protamine sulfate neutralizes unfractionated heparin, whereas no specific antidotes exist for low-molecular-weight heparins or fondaparinux...Idarucizumab specifically reverses dabigatran, although delayed dabigatran rebound can occur. Andexanet alfa targets direct oral factor Xa inhibitors, but uncertainties regarding the efficacy-safety balance, monitoring, rebound, perioperative use, and cost have prompted off-label use of four-factor prothrombin complex concentrates, for which stronger evidence is needed...Emerging agents aim to broaden targets and improve safety. Building high-quality evidence remains essential to advancing global, patient-centered anticoagulant and hemostatic care."

Journal • Review

Anticoagulation associated intracerebral haemorrhage trends, treatment and outcomes in a metropolitan cohort: analysed by availability of specific versus non-specific reversal agents. (PubMed, BMJ Neurol Open) - "Direct oral anticoagulants (rivaroxaban, apixaban, dabigatran) and warfarin treatment are associated with an increased risk of intracerebral haemorrhage (ICH). Specific reversal exists for warfarin (vitamin K/prothrombin complex concentrate (PCC)) and dabigatran (idarucizumab)...There was no difference between time to administration of PCC and time to antihypertensive metrics. The high mortality in our study underscores the need for effective optimised and timely treatments."

Journal • Cardiovascular • CNS Disorders • Vascular Neurology

Severe Hemoptysis Caused by Right Inferior Pulmonary Vein Perforation During Circular-Array Pulsed-Field Ablation. (PubMed, JACC Case Rep) - "Careful manipulation of a guidewire and a circular-array catheter is essential in narrow, branching pulmonary vein to prevent vascular injury."

Journal • Atrial Fibrillation • Cardiovascular

Safety and Outcomes of Dabigatran Reversal With Idarucizumab Before IV Thrombolysis in Patients With Acute Ischemic Stroke. (PubMed, Neurology) - "In our observational study with patients with AIS, IVT treatment after dabigatran reversal was safe and had similar outcomes to IVT treatment without previous OAC. Furthermore, comparison between dabigatran reversal vs no reversal also indicates that IVT is safe for patients on dabigatran without idarucizumab reversal, which is currently being investigated in clinical trials."

Journal • Observational data • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Ischemic stroke

Current Status of the Safety and Efficacy of Antidotes for Direct Oral Anticoagulants in Japan. (PubMed, JACC Asia) - No abstract available

Journal

Intravenous thrombolysis for acute cerebral embolism during atrial fibrillation ablation: a case report and systematic review with meta-analysis. (PubMed, Front Cardiovasc Med) - "The patient had been receiving dabigatran and was treated with intravenous idarucizumab followed by intravenous alteplase. This case, together with accumulating evidence from the literature, supports the short-term safety and clinical effectiveness of idarucizumab-enabled intravenous thrombolysis in dabigatran-treated patients with periprocedural acute ischemic stroke. Therefore, early anticoagulant reversal followed by prompt reperfusion therapy may represent a feasible and safe therapeutic strategy in carefully selected patients."

Journal • Retrospective data • Review • Atrial Fibrillation • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Efficacy and Safety of Direct Oral Anticoagulant Reversal Agents in Intracerebral Hemorrhage: A Systematic Review and Meta-analysis (AAN 2026) - "Background Patients on DOACs who develop ICH often receive reversal therapy with agents like 4-factor prothrombin complex concentrate (4F-PCC), andexanet alfa (AA), or idarucizumab. Head-to-head comparisons suggest similar reversal efficacy between AA and 4F-PCC. Findings support the effectiveness of available reversal strategies while underscoring the need for randomized trials to confirm comparative safety and longer-term outcomes."

Retrospective data • Review • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

Anticoagulation Stewardship Program in the DOAC Era. (PubMed, J Clin Med) - "Recent regulatory changes have altered the reversal landscape, notably with the withdrawal of andexanet alfa from the U.S. market... Idarucizumab remains the only FDA-approved specific antidote for dabigatran...Ciraparantag, a universal reversal agent, is currently in Phase III development...Success in DOAC-associated bleeding management now depends on optimizing PCC-based strategies, integrating systematic stewardship approaches, and preparing for emerging universal antidotes. Institutions must urgently update algorithms, ensure PCC availability, and monitor outcomes in this new therapeutic environment."

Journal • Review

Disseminated Intravascular Coagulation Following Idarucizumab and Andexanet Alfa: Assessment of a Signal of Disproportionate Reporting From the Food and Drugs Administration Adverse Event Reporting System (FAERS) Database. (PubMed, Drug Saf) - "The disproportionality analysis of the FAERS allowed us to highlight the associations between idarucizumab-DIC and andexanet-alfa-DIC, which might otherwise have remained unobserved due to the rarity of DIC and the low utilization of idarucizumab and andexanet alfa. Although the case-by-case evaluation was limited by the intrinsic indication bias, a causal link remained possible in those cases that occurred soon after administration. Since DIC is a life-threatening and often fatal condition, further investigation is warranted while close follow-up of high-risk patients may be considered to promptly detect any sign of coagulopathy following the administration of DOAC reversal agents. Any such observed adverse events should be reported to the relevant pharmacovigilance system in a timely manner."

Adverse events • Journal • Cardiovascular • Hematological Disorders

Impact of Pharmacy Response to Hemorrhagic Emergencies on Time to Antithrombotic Reversal (SCCM 2026) - "Available reversal agents were four-factor prothrombin complex concentrate, phytonadione, protamine, idarucizumab, and desmopressin. Pharmacy response to ICH emergencies significantly reduced time from order entry to antithrombotic reversal agent administration."

Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Subarachnoid Hemorrhage

Time to Anticoagulation Reversal at a Large, Academic, Regional Referral Center (SCCM 2026) - "The purpose of this study was to determine the time from anticoagulation reversal order to administration in patients with major bleeding of all types and to identify potential operational or clinical barriers that could result in delayed administration. This was a retrospective chart review at a large academic level 1 trauma center of adult patients that received anticoagulation reversal with four-factor prothrombin complex concentrate (4F-PCC), andexanet alfa (AA), or idarucizumab from January 1, 2024 to December 31, 2024...Patients were primarily female (52.1%), median age of 75, on apixaban prior to admission (72.9%), presented with ICH (41.7%), and located in the ED (57.3%)... Overall median time to anticoagulation reversal for all major bleeding types met current recommendations for time to administration in 60 minutes or less, however, median door to anticoagulation reversal for patients located in the ED did not achieve this goal."

Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Mood Disorders

Factor IIa Inhibitors: Mechanisms, Clinical Complications, and Advances in Reversal Strategies (THSNA 2026) - "Direct thrombin inhibitors, such as dabigatran, argatroban, and bivalirudin, provide targeted anticoagulation across a wide range of cardiovascular and hematologic settings...Special focus was placed on specific reversal agents such as idarucizumab, the use of four-factor prothrombin complex concentrates, and investigational options such as Ciraparantag...Idarucizumab, a monoclonal antibody fragment with strong binding affinity for dabigatran, is the only United States Food and Drug Administration-approved reversal agent for any direct thrombin inhibitor and rapidly restores clotting parameters...Continued clinical research will determine its safety, efficacy, and overall impact on the future of anticoagulation management. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author."

Clinical • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Thrombocytopenia • Venous Thromboembolism

Dabigatran-induced Gastrointestinal Bleed Treated by 4-factor Prothrombin Complex Concentrate in a Tertiary Care Hospital in Sikkim. (PubMed, J Assoc Physicians India) - "Idarucizumab is a specific dabigatran reversal drug that the United States Food and Drug Administration (US FDA) has approved in the event of a significant bleeding caused by this drug. He could be sent home after 4 days. After 1 month, he returned for follow-up with no further complications."

Journal • Cardiovascular • Hematological Disorders

Management of Direct Oral Anticoagulants in Adult Patients Undergoing Cardiac Surgery: Joint Consensus Statement by the Society of Cardiovascular Anesthesiologists and the Society of Thoracic Surgeons (STS 2026) - "Andexanet alfa is not recommended for emergency cardiac surgery where cardiopulmonary bypass is needed due to the risk of heparin resistance...For the direct thrombin inhibitor dabigatran, Idarucizumab may be considered first-line, with 4F-PCC as a second line therapy or even hemodialysis...This expert consensus provides guidance on the perioperative management of DOACs for adult patients undergoing cardiac surgery with the goal to enhance patient safety and outcomes. Table Image"

Clinical • Surgery • Anesthesia • Cardiovascular • Nephrology • Renal Disease

Balancing Bleeding and Thrombosis in Dental Management of Patients on Novel Oral Anticoagulants: A Narrative Evidence Synthesis. (PubMed, Cureus) - "Reversal agents, including idarucizumab for dabigatran and andexanet alfa for apixaban, edoxaban, and rivaroxaban, remain emergency-only tools because of their logistical and prothrombotic constraints. Nonetheless, this narrative review enables safe continuation in most scenarios, minimizing morbidity through pharmacokinetic awareness, local hemostatic rigor, and surgical conservatism. Future prospective registries with standardized outcomes are essential to validate interruption thresholds and adjunctive modalities in this expanding anticoagulation population."

Journal • Review • Cardiovascular • Hematological Disorders • Inflammation • Orthopedics • Thrombosis