title: Hemorrhagic complications associated with dabigatran use.
abstract: OBJECTIVE
  Dabigatran is a direct thrombin inhibitor approved for anticoagulation in non-valvular atrial fibrillation and, in some countries, for thromboembolism prophylaxis following select orthopedic surgeries. Despite decreased rates of thromboembolism, bleeding remains a risk due to the inability to conveniently monitor anticoagulant effect and the lack of a reversal agent.
  
  
  METHODS
  We present four cases of dabigatran-related bleeding. A 79-year-old man on aspirin, clopidogrel, and dabigatran presented with rectal bleeding and epistaxis. He died despite transfusion and administration of prothrombin complex concentrate. A 73-year-old woman on dabigatran and aspirin survived after transfusion and an emergent sternotomy for cardiac tamponade. An 86 year-old man with kidney disease and thrombocytopenia received packed red blood cells, platelets, and fresh frozen plasma for rectal bleeding while on dabigatran. An 80 year-old man on dabigatran had a subdural hematoma after falling and hitting his head. Serial imaging showed no progression.
  
  
  CONCLUSIONS
  The absence of a reversal agent for dabigatran raises concern for uncontrollable bleeding and death. Dabigatran's listed contraindications include active bleeding and a history of dabigatran hypersensitivity reaction. Wider use may result in bleeding rates higher than anticipated from clinical trials. Risks factors that may have contributed to bleeding in these patients include concomitant bleeding diathesis, antiplatelet agent use, renal insufficiency, advanced age, and fall risks.
authors.affiliation: New York City Poison Control Center, Bellevue Hospital Center, New York University, New York, NY 10016, USA. betty.chen@nyumc.org
authors.forename: Betty C
authors.initials: BC
authors.lastname: Chen
authors.forename: Aaron D
authors.initials: AD
authors.lastname: Viny
authors.forename: Fiona M
authors.initials: FM
authors.lastname: Garlich
authors.forename: Paul
authors.initials: P
authors.lastname: Basciano
authors.forename: Mary Ann
authors.initials: MA
authors.lastname: Howland
authors.forename: Silas W
authors.initials: SW
authors.lastname: Smith
authors.forename: Robert S
authors.initials: RS
authors.lastname: Hoffman
authors.forename: Lewis S
authors.initials: LS
authors.lastname: Nelson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000991:Antithrombins / Q000009:adverse effects*; D001562:Benzimidazoles / Q000009:adverse effects*; D000069604:Dabigatran; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D008297:Male; D015091:beta-Alanine / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000991:Antithrombins; D001562:Benzimidazoles; D015091:beta-Alanine; D000069604:Dabigatran