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

Chen, Esa Y. H., Diug, Basia, Bell, J. Simon, Mc Namara, Kevin P., Dooley, Michael J., Kirkpatrick, Carl M., McNeil, John J., Caughey, Gillian E. and Ilomäki, Jenni 2016, Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia, Therapeutic advances in drug safety, vol. 7, no. 1, pp. 4-10, doi: 10.1177/2042098615618171.

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Title Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia
Author(s) Chen, Esa Y. H.
Diug, Basia
Bell, J. Simon
Mc Namara, Kevin P.ORCID iD for Mc Namara, Kevin P. orcid.org/0000-0001-6547-9153
Dooley, Michael J.
Kirkpatrick, Carl M.
McNeil, John J.
Caughey, Gillian E.
Ilomäki, Jenni
Journal name Therapeutic advances in drug safety
Volume number 7
Issue number 1
Start page 4
End page 10
Total pages 7
Publisher Sage
Place of publication London, Eng.
Publication date 2016-02
ISSN 2042-0986
2042-0994
Summary 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.
Language eng
DOI 10.1177/2042098615618171
Field of Research 111799 Public Health and Health Services not elsewhere classified
Socio Economic Objective 920499 Public Health (excl. Specific Population Health) not elsewhere classified
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2016, Sage Publications
Persistent URL http://hdl.handle.net/10536/DRO/DU:30083347

Document type: Journal Article
Collection: School of Medicine
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