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Systematic Review

Direct oral anticoagulants toxicity in children: an overview and practical guide

ORCID Icon, , ORCID Icon & ORCID Icon
Pages 1183-1192 | Received 02 Feb 2022, Accepted 02 Aug 2022, Published online: 09 Aug 2022

References

  • Chan N, Sobieraj-Teague M, Eikelboom JW. Direct oral anticoagulants: evidence and unresolved issues. Lancet. 2020;396(10264):1767–1776.
  • Franco Moreno AI, Martín Díaz RM, García Navarro MJ. Direct oral anticoagulants: an update. Med Clin (Barc). 2018;151(5):198–206.
  • Chen A, Stecker E, AW B. Direct oral anticoagulant use: a practical guide to common clinical challenges. J Am Heart Assoc. 2020;9(13):e017559.
  • Fda.gov [internet]. United States: U.S. Food and Drug Administration; cited 2021 Jun 21. Available from: http://fda.gov/news-events/press-announcements/fda-approves-first-oral-blood-thinning-medication-children
  • Bulut M, Küçük Alemdar D, Bulut A, et al. Evaluation of accidental and intentional pediatric poisoning: retrospective analysis in an emergency Department of Turkey. J Pediatr Nurs. 2021;63:e44–e49.
  • Ha C, Howland MA, and Su M. Rivaroxaban overdose. React Wkly. 2021;1847(1): 401-401. DOI: 10.1007/s40278-021-92956-9
  • Carr BM, Roy DJ, Bangh SA, et al. Anti-factor Xa monitoring and activated Charcoal for a pediatric patient with Rivaroxaban overdose. Clin Pract Cases Emerg Med. 2018;2(3):247–250.
  • Conway SE, Schaeffer SE, Harrison DL. Evaluation of dabigatran exposures reported to poison control centers. Ann Pharmacother. 2014;48(3):354–360.
  • Ha C, Howland MA, Su M. Acute Rivaroxaban overdose confirmed with Heparin Anti-Xa activity and serum concentrations in an adolescent patient. Proceeding of the North American Congress of Clinical Toxicology; 2020 Sep 10-14; San Francisco, California: Taylor & Francis; 2020.
  • Ha CJ, Harmouche E, Howland MA, et al. Two cases of acute direct oral anticoagulant overdose without adverse effect. J Pediatr Hematol Oncol. 2022;44(2):e447–9.
  • Launay M, Nasser Y, Maubert I, et al. Accidental apixaban intoxication in a 23-month-old child: a case report. BMC Pediatr. 2020;20(1):546.
  • Levine M, Pizon A, Beuhler M, et al. Exploratory ingestions of novel anticoagulants and antiplatelets: what is the risk? Pediatr Emerg Care. 2020;36(6):283–285.
  • Shapiro S, Bhatnagar N, Khan A, et al. Idarucizumab for dabigatran overdose in a child. Br J Haematol. 2018;180(3):457–459.
  • Spiller HA, Mowry JB, Aleguas A Jr., et al. An observational study of the factor Xa inhibitors Rivaroxaban and Apixaban as reported to eight poison centers. Ann Emerg Med. 2016;67(2):189–195.
  • Stevenson JW, Minns AB, Smollin C, et al. An observational case series of dabigatran and rivaroxaban exposures reported to a poison control system. Am J Emerg Med. 2014;32(9):1077–1084.
  • Weirthein J, Scolnik D, Milshtein NY, et al. Accidental Rivaroxaban Intoxication in a boy: some lessons in managing new oral anticoagulants in children. Pediatr Emerg Care. 2019;35(3):e44–6.
  • Lefebvre S, Fourel I, and Queffélec S, et al. Chapter 2: Poisoning by Anticoagulant Rodenticides in Humans and Animals: Causes and Consequences. In Malangu N, editor. Poisoning - From Specific Toxic Agents to Novel Rapid and Simplified Techniques for Analysis. London: IntechOpen. 2017;11–32. Available from: https://www.intechopen.com/books/5873
  • Newall F, Branchford B, Male C. Anticoagulant prophylaxis and therapy in children: current challenges and emerging issues. J Thromb Haemost. 2018;16(2):196–208.
  • Bosch A, Albisetti M. Management of venous thromboembolism in children: current recommendations and therapeutic options. Ther Clin Risk Manag. 2020;16:673–679.
  • Rühle F, Stoll M. Advances in predicting venous thromboembolism risk in children. Br J Haematol. 2018;180(5):654–665.
  • Albisetti M. Use of direct oral anticoagulants in children and adolescents. Hamostaseologie. 2020;40(1):64–73.
  • Halton J, Brandão LR, Luciani M, et al. Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial. Lancet Haematol. 2021;8(1):e22–33.
  • Boehringer Ingelheim Pharmaceuticals, Inc. PRADAXA (dabigatran etexilate mesylate) [package insert] Food and Drug Administration website. [cited 2021]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022512s007lbl.pdf
  • Bayer HealthCare. Janssen Pharmaceuticals, Inc. XARELTO (rivaroxaban) [package insert]. U.S. Food and Drug Administration website; [cited 2021]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202439s021lbl.pdf
  • Bristol-Myers Squibb Company. ELIQUIS (apixaban)[package insert]. U.S. Food and Drug Administration website; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202155s000lbl.pdf
  • Portola Pharmaceuticals, Inc. BEVYXXA (betrixaban)[package insert]. U.S. Food and Drug Administration website; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383S000lbl.pdf
  • Daiichi Sankyo Company. SAVAYSA (edoxaban)[package insert]. U.S. Food and Drug Administration website; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316lbl.pdf
  • Raval AN, Cigarroa JE, Chung MK, et al. Management of patients on non-vitamin K antagonist oral anticoagulants in the acute care and periprocedural setting: a scientific statement from the American Heart Association. Circulation. 2017;135(10):e604–33.
  • Young G, Lensing AWA, Monagle P, et al. Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation. J Thromb Haemost. 2020;18(7):1672–1685.
  • Kubitza D, Willmann S, Becka M, et al. Exploratory evaluation of pharmacodynamics, pharmacokinetics and safety of rivaroxaban in children and adolescents: an EINSTEIN-Jr phase I study. Thromb J. 2018;16:31.
  • Monagle P, Lensing AWA, Thelen K, et al. Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies. Lancet Haematol. 2019;6(10):e500–9.
  • Willmann S, Thelen K, Kubitza D, et al. Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN-Jr phase I study. Thromb J. 2018;16(1):32.
  • Kubitza D, Becka M, Roth A, et al. Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects. Curr Med Res Opin. 2008;24(10):2757–2765.
  • Linkins LA, Moffat K. Monitoring the anticoagulant effect after a massive rivaroxaban overdose. J Thromb Haemost. 2014;12(9):1570–1571.
  • Payne RM, Burns KM, Glatz AC, et al. A multi-national trial of a direct oral anticoagulant in children with cardiac disease: design and rationale of the Safety of ApiXaban On Pediatric Heart disease On the preventioN of Embolism (SAXOPHONE) study. Am Heart J. 2019;217:52–63.
  • von Vajna E, Alam R, So TY. Current clinical trials on the use of direct oral anticoagulants in the pediatric population. Cardiol Ther. 2016;5(1):19–41.
  • Frost C, Wang J, Nepal S, et al. Apixaban, an oral, direct factor Xa inhibitor: single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects. Br J Clin Pharmacol. 2013;75(2):476–487.
  • Tomaselli GF, Mahaffey KW, Cuker A, et al. 2020 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology solution set oversight committee. J Am Coll Cardiol. 2020 Aug 4;76(5):594–622.
  • Crowther M, Cuker A. How can we reverse bleeding in patients on direct oral anticoagulants? Kardiol Pol. 2019;77(1):3–11.
  • Goobie SM, Faraoni D. Tranexamic acid and perioperative bleeding in children: what do we still need to know? Curr Opin Anaesthesiol. 2019;32(3):343–352.
  • Albisetti M, Schlosser A, Brueckmann M, et al., Rationale and design of a phase III safety trial of idarucizumab in children receiving dabigatran etexilate for venous thromboembolism. Res Pract Thromb Haemost. 2018;2(1):69–76.
  • Arnold P. 20 - Medications for Hemostasis. In: Coté CJ, Lerman J, Anderson BJ, editors. A practice of Anesthesia for infants and children. 6th ed. Philadelphia: Elsevier; 2019. p. 482–499.e7.
  • Karube T, Andersen C, Tobias JD. Single-Center use of prothrombin complex concentrate in pediatric patients. J Pediatr Intensive Care. 2020;9(2):106–112.
  • Baxter International Inc. FEIBA (Anti-Inhibitor Coagulant Complex)[package insert]. U.S. Food and Drug Administration website; Available from: https://www.fda.gov/media/78852/download

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