title: Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia.
abstract: OBJECTIVE
  The objective of our study was to describe spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia.
  
  
  METHODS
  Data were sourced from the Australian Therapeutic Goods Administration (TGA) Database of Adverse Event Notifications between June 2009 and May 2014. Records of haemorrhagic adverse events in which rivaroxaban or dabigatran was considered as a potential cause were analysed.
  
  
  RESULTS
  There were 240 haemorrhagic adverse events associated with rivaroxaban and 504 associated with dabigatran. Age was specified for 164 (68%) haemorrhages associated with rivaroxaban, of which 101 occurred in people aged ⩾75 years. Age was specified for 437 (87%) haemorrhages associated with dabigatran, of which 300 occurred in people aged ⩾75 years. Time from treatment initiation to haemorrhage was specified for 122 (51%) haemorrhages associated with rivaroxaban, with 69 (57%) haemorrhages occurring within 30 days of rivaroxaban initiation. Time from treatment initiation to haemorrhage was specified for 253 (50%) haemorrhages associated with dabigatran, with 123 (49%) haemorrhages occurring within 30 days of dabigatran initiation. Gastrointestinal (GI) haemorrhages were the most frequent type of haemorrhages associated with both rivaroxaban (n = 105, 44%) and dabigatran (n = 302, 60%). Data were available on the severity of haemorrhage for 101 (42%) haemorrhages associated with rivaroxaban, with haemorrhage leading to death in 17 people. The severity of haemorrhage was specified for 384 (76%) haemorrhages associated with dabigatran, with haemorrhage leading to death in 61 people.
  
  
  CONCLUSIONS
  Our study highlights the need for research on the haemorrhagic complications of anticoagulation in clinical care. A considerable proportion of reported haemorrhagic events occurred within 30 days of rivaroxaban and dabigatran initiation. This highlights the importance of considering bleeding risk at the time of treatment initiation.
authors.affiliation: Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia.
authors.forename: Esa Y H
authors.initials: EY
authors.lastname: Chen
authors.affiliation: Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Basia
authors.initials: B
authors.lastname: Diug
authors.affiliation: Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Victoria, and Sansom Institute for Health Research, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia.
authors.forename: J Simon
authors.initials: JS
authors.lastname: Bell
authors.affiliation: Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Victoria, and Greater Green Triangle University Department of Rural Health, Flinders University, SA, and Deakin University, Burwood, Victoria, Australia.
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Mc Namara
authors.affiliation: Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, and Pharmacy Department, Alfred Health, Melbourne, Victoria, Australia.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Dooley
authors.affiliation: Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia.
authors.forename: Carl M
authors.initials: CM
authors.lastname: Kirkpatrick
authors.affiliation: Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: John J
authors.initials: JJ
authors.lastname: McNeil
authors.affiliation: Sansom Institute for Health Research, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia.
authors.forename: Gillian E
authors.initials: GE
authors.lastname: Caughey
authors.affiliation: Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia.
authors.forename: Jenni
authors.initials: J
authors.lastname: Ilomäki
keywords: adverse drug event; anticoagulants; dabigatran; gastrointestinal haemorrhage; haemorrhage; rivaroxaban
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