title: Evaluation of dabigatran exposures reported to poison control centers.
abstract: BACKGROUND
  Dabigatran is a novel oral anticoagulant for which a well-defined range of toxicity and proven antidote has not been established.
  
  
  OBJECTIVE
  The primary objective of this study was to characterize dabigatran exposures reported to poison centers by dose ingested, clinical effects, treatments used, and managment sites to gain a better understanding of patient outcomes.
  
  
  METHODS
  A retrospective database review was conducted for dabigatran exposures reported to the National Poison Data System for the American Association of Poison Control Centers (AAPCC) over the period October 2010 to December 2012.
  
  
  RESULTS
  There were 802 human dabigatran exposures involving adults predominantly (91% of cases). Exposure chronicity was acute in 43%, acute-on-chronic in 46%, and chronic in 11%, with the most common reason for an exposure call being an unintentional therapeutic error (70.6%). The most common management sites were on-site in 72% of cases and within a health care facility for 26%. Bleeding events and coagulopathies were the most commonly observed clinical effects. Treatments administered included activated charcoal, blood and coagulation products, hemodialysis, and supportive measures. Confirmed outcomes included death in 13 patients (1.6%), major effects in 23 (2.9%), and moderate effects in 50 (6.2%). More severe outcomes were significantly associated with adverse drug reactions, patients ≥65 years of age, those treated with blood and coagulation products and/or dialysis, and renal dysfunction (P < .05). Children experienced few moderate effects and no major effects or deaths.
  
  
  CONCLUSIONS
  Severe outcomes from dabigatran exposures were not common, occurring in approximately 5% of cases.
authors.affiliation: University of Oklahoma College of Pharmacy, Oklahoma City, OK, USA.
authors.forename: Susan E
authors.initials: SE
authors.lastname: Conway
authors.forename: Scott E
authors.initials: SE
authors.lastname: Schaeffer
authors.forename: Donald L
authors.initials: DL
authors.lastname: Harrison
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects* / Q000506:poisoning; D001562:Benzimidazoles / Q000009:adverse effects* / Q000506:poisoning; D001777:Blood Coagulation / Q000187:drug effects; D002648:Child; D000069604:Dabigatran; D016208:Databases, Factual; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D011039:Poison Control Centers; D012189:Retrospective Studies; D015091:beta-Alanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000506:poisoning
chemical_list: D000925:Anticoagulants; D001562:Benzimidazoles; D015091:beta-Alanine; D000069604:Dabigatran
keywords: dabigatran; direct thrombin inhibitor; hemorrhage; overdose