Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia

Esa Y H Chen; Basia Diug; J Simon Bell; Kevin P Mc Namara; Michael J Dooley; Carl M Kirkpatrick; John J McNeil; Gillian E Caughey; Jenni Ilomäki

doi:10.1177/2042098615618171

Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia

Ther Adv Drug Saf. 2016 Feb;7(1):4-10. doi: 10.1177/2042098615618171.

Authors

Esa Y H Chen¹, Basia Diug², J Simon Bell³, Kevin P Mc Namara⁴, Michael J Dooley⁵, Carl M Kirkpatrick¹, John J McNeil², Gillian E Caughey⁶, Jenni Ilomäki¹

Affiliations

¹ Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia.
² Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
³ 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.
⁴ 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.
⁵ Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, and Pharmacy Department, Alfred Health, Melbourne, Victoria, Australia.
⁶ Sansom Institute for Health Research, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia.

Abstract

Objectives: 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.

Keywords: adverse drug event; anticoagulants; dabigatran; gastrointestinal haemorrhage; haemorrhage; rivaroxaban.