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Acute unintentional single-substance pediatric exposures to direct factor Xa inhibitors reported to US Poison

Matthew Kolbeck1,2, Deirdre Regan1, Michael Hodgman1,2

  • 1Department of Emergency Medicine, SUNY Upstate Medical University, Syracuse, NY, USA.

Clinical Toxicology (Philadelphia, Pa.)
|March 16, 2026
PubMed

Insights

Pediatric factor Xa inhibitor ingestions show low toxicity. Unintentional exposures in children under six years old did not result in clinically significant bleeding events, indicating a favorable safety profile.

Area of Science:

  • Pediatric Toxicology
  • Pharmacovigilance
  • Anticoagulant Therapy

Background:

  • Direct factor Xa inhibitors are common anticoagulants with well-established adult safety profiles.
  • Limited data exist regarding pediatric exposures to these medications.
  • Understanding outcomes of unintentional pediatric ingestions is crucial for clinical management.

Purpose of the Study:

  • To analyze referral patterns, clinical outcomes, and treatments for unintentional pediatric factor Xa inhibitor ingestions.
  • To assess the safety and toxicity of direct factor Xa inhibitors in young children following acute exposure.
  • To provide data on the management of pediatric Factor Xa inhibitor ingestions.

Main Methods:

  • Retrospective review of cases reported to the National Poison Data System® (2011-2019).
  • Inclusion criteria: age <6 years, single-substance, unintentional ingestion of a direct factor Xa inhibitor.
  • Exclusion of cases with non-relevant outcomes or insufficient follow-up data.

Main Results:

  • 744 cases met inclusion criteria; 350 managed at home with mostly no/minor effects.
  • 394 cases evaluated at healthcare facilities showed predominantly no (85.5%) or minor (8.4%) effects.
  • No clinical bleeding events were reported; one major effect case had coagulopathy but no coded bleeding.

Conclusions:

  • Acute, unintentional, single-substance ingestions of factor Xa inhibitors in children <6 years are associated with low toxicity.
  • Clinically significant bleeding is unlikely in pediatric patients following such exposures.
  • Findings support the generally safe profile of these anticoagulants in acute pediatric ingestions.
Abstract

Keywords:
Anticoagulant overdoseapixabanpediatric poisoningrivaroxabanunintentional

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