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

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

Research output: Contribution to journal › Article › peer-review

9 Citations (Scopus)

Abstract

The objective of our study was to describe spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia. 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. 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. 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.

Original language	English
Pages (from-to)	4-10
Number of pages	7
Journal	Therapeutic Advances in Drug Safety
Volume	7
Issue number	1
DOIs	https://doi.org/10.1177/2042098615618171
Publication status	Published or Issued - Feb 2016
Externally published	Yes

Keywords

adverse drug event
anticoagulants
dabigatran
gastrointestinal haemorrhage
haemorrhage
rivaroxaban

ASJC Scopus subject areas

Pharmacology (medical)

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10.1177/2042098615618171

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title = "Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia",

abstract = "The objective of our study was to describe spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia. 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. 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. 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",

author = "Chen, {Esa Y.H.} and Basia Diug and Bell, {J. Simon} and {mc Namara}, {Kevin P.} and Dooley, {Michael J.} and Kirkpatrick, {Carl M.} and McNeil, {John J.} and Caughey, {Gillian E.} and Jenni Ilom{\"a}ki",

note = "Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: JI was supported by a National Health and Medical Research Council Fellowship (grant number 1072137). KM was supported by a Heart Foundation postdoctoral award (grant number 100187). ",

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AU - Diug, Basia

AU - Bell, J. Simon

AU - mc Namara, Kevin P.

AU - Dooley, Michael J.

AU - Kirkpatrick, Carl M.

AU - McNeil, John J.

AU - Caughey, Gillian E.

AU - Ilomäki, Jenni

N1 - Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: JI was supported by a National Health and Medical Research Council Fellowship (grant number 1072137). KM was supported by a Heart Foundation postdoctoral award (grant number 100187).

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AB - The objective of our study was to describe spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia. 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. 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. 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.

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

Abstract

Keywords

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