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. 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.
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.
Entities:
Keywords:
adverse drug event; anticoagulants; dabigatran; gastrointestinal haemorrhage; haemorrhage; rivaroxaban
Authors: Cameron J McDonald; Lisa M Kalisch Ellett; John D Barratt; Gillian E Caughey Journal: Pharmacoepidemiol Drug Saf Date: 2014-05-20 Impact factor: 2.890
Authors: John W Eikelboom; Lars Wallentin; Stuart J Connolly; Mike Ezekowitz; Jeff S Healey; Jonas Oldgren; Sean Yang; Marco Alings; Scott Kaatz; Stefan H Hohnloser; Hans-Christoph Diener; Maria Grazia Franzosi; Kurt Huber; Paul Reilly; Jeanne Varrone; Salim Yusuf Journal: Circulation Date: 2011-05-16 Impact factor: 29.690
Authors: Andreas Clemens; Siyang Peng; Sarah Brand; Martina Brueckmann; Anuraag Kansal; Jonathan Lim; Herbert Noack; Stephen Sander; Sonja Sorensen Journal: Am J Cardiol Date: 2014-07-02 Impact factor: 2.778
Authors: Troy C Sarich; Jonathan H Seltzer; Scott D Berkowitz; James Costin'; John T Curnutte; C Michael Gibson; Maureane Hoffman; Edvardas Kaminskas; Mitchell W Krucoff; Jerrold H Levy; Paul D Mintz; Paul A Reilly; Philip T Sager; Daniel E Singer; Norman Stockbridge; Jeffrey I Weitz; Peter R Kowey Journal: Am Heart J Date: 2015-03-26 Impact factor: 4.749
Authors: Sally Tamayo; W Frank Peacock; Manesh Patel; Nicholas Sicignano; Kathleen P Hopf; Larry E Fields; Troy Sarich; Shujian Wu; Daniel Yannicelli; Zhong Yuan Journal: Clin Cardiol Date: 2015-01-14 Impact factor: 2.882