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An Observational Study of the Factor Xa Inhibitors Rivaroxaban and Apixaban as Reported to Eight Poison Centers
Henry A Spiller1, James B Mowry2, Alfred Aleguas3
1Central Ohio Poison Center, Nationwide Children's Hospital, Columbus, OH; Department of Pediatrics, Ohio State University College of Medicine, Columbus, OH.
Annals of Emergency Medicine
|August 24, 2015
Summary
Bleeding from factor Xa inhibitors like rivaroxaban and apixaban is uncommon, even with overdose. Laboratory tests may not reliably predict bleeding risk, but massive ingestions, such as in suicide attempts, can cause significant anticoagulation.
Area of Science:
- Pharmacology
- Toxicology
- Internal Medicine
Background:
- Rivaroxaban and apixaban are novel oral anticoagulants targeting factor Xa.
- These drugs are administered at fixed doses without routine laboratory monitoring.
- Limited data exist on the effects of supratherapeutic doses or overdoses of these agents.
Purpose of the Study:
- To characterize the clinical effects of exposure to rivaroxaban and apixaban.
- To evaluate the association between laboratory coagulation parameters and bleeding events.
- To assess the safety of single exploratory ingestions in children.
Main Methods:
- Retrospective study of cases from 8 regional poison centers across 9 states.
- Inclusion criteria: single-substance exposure to rivaroxaban or apixaban.
- Data collected via chart review, including case narratives.
Main Results:
- 223 patients included: 198 exposed to rivaroxaban, 25 to apixaban.
- Bleeding reported in 7% of patients (15 total); most cases involved long-term ingestion.
- Coagulation tests were often normal in patients with bleeding; overdose in suicide attempts caused significant anticoagulation.
- No toxicity observed in children with single ingestions.
Conclusions:
- Bleeding following single-agent factor Xa inhibitor ingestion is uncommon.
- Standard coagulation tests (PT, PTT, INR) appear unreliable for predicting bleeding risk.
- Massive acute ingestion, particularly in suicide attempts, can lead to significant anticoagulation and requires careful management.

