Clinical toxicology (Philadelphia, Pa.) · 2026
Acute unintentional single-substance pediatric exposures to direct factor Xa inhibitors reported to US Poison Centers, 2011-2019.
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Kolbeck Matthew, Regan Deirdre, Hodgman Michael, Calleo Vincent
Аннотация
INTRODUCTION: Direct factor Xa inhibitors are widely used anticoagulants. Safety in adults is well studied, however limited data exist for pediatric exposures. The objective of this study is to describe referral patterns, clinical outcomes, and treatment modalities for unintentional pediatric single-substance ingestion of factor Xa inhibitors as reported to the National Poison Data System®.
METHODS: This is a retrospective review of cases reported to the National Poison Data System® from January 1, 2011 to December 31, 2019. Inclusion criteria were age <6 years with single-substance, unintentional ingestion of a direct factor Xa inhibitor. Cases were excluded if the medical outcome was coded as unrelated effect, confirmed non-exposure, not followed (non-toxic/minimal toxicity), unable to follow (potentially toxic), or outcome not provided. Data abstracted included medical outcomes, level of care, clinical effects, and therapies.
RESULTS: A total of 744 cases met inclusion criteria. Among 350 cases managed at home, outcomes included 346 cases with "no effect" and four cases with "minor effect". Among 394 cases treated/evaluated at a healthcare facility, reported medical outcomes included 337 (85.5%) cases with "no effect", 33 (8.4%) with "minor effect", 22 (5.6%) with "moderate effect", and two (0.5%) with "major effect". No clinical effects related to bleeding were reported. One hundred twenty-two patients received activated charcoal. One of the two cases with major effect involved ingestion of up to 500 mg rivaroxaban with laboratory coagulopathy, but bleeding was not coded as a clinical effect.
DISCUSSION: In this cohort of patients less than six years of age with acute, unintentional single-substance ingestion of direct factor Xa inhibitors, no cases had bleeding coded as a clinical effect. These findings are consistent with the previously described low toxicity profile of acute ingestions of these medications in children.
CONCLUSIONS: These data suggest that asymptomatic, unintentional, single substance exposures to factor Xa inhibitors in patients <6 years of age are unlikely to develop clinically significant bleeding.
METHODS: This is a retrospective review of cases reported to the National Poison Data System® from January 1, 2011 to December 31, 2019. Inclusion criteria were age <6 years with single-substance, unintentional ingestion of a direct factor Xa inhibitor. Cases were excluded if the medical outcome was coded as unrelated effect, confirmed non-exposure, not followed (non-toxic/minimal toxicity), unable to follow (potentially toxic), or outcome not provided. Data abstracted included medical outcomes, level of care, clinical effects, and therapies.
RESULTS: A total of 744 cases met inclusion criteria. Among 350 cases managed at home, outcomes included 346 cases with "no effect" and four cases with "minor effect". Among 394 cases treated/evaluated at a healthcare facility, reported medical outcomes included 337 (85.5%) cases with "no effect", 33 (8.4%) with "minor effect", 22 (5.6%) with "moderate effect", and two (0.5%) with "major effect". No clinical effects related to bleeding were reported. One hundred twenty-two patients received activated charcoal. One of the two cases with major effect involved ingestion of up to 500 mg rivaroxaban with laboratory coagulopathy, but bleeding was not coded as a clinical effect.
DISCUSSION: In this cohort of patients less than six years of age with acute, unintentional single-substance ingestion of direct factor Xa inhibitors, no cases had bleeding coded as a clinical effect. These findings are consistent with the previously described low toxicity profile of acute ingestions of these medications in children.
CONCLUSIONS: These data suggest that asymptomatic, unintentional, single substance exposures to factor Xa inhibitors in patients <6 years of age are unlikely to develop clinically significant bleeding.