Risk of intraocular hemorrhage with new oral anticoagulants

PurposeTo assess the risk of intraocular hemorrhage with warfarin and new oral anticoagulants (NOACs).MethodsWe ascertained all reported cases of intraocular hemorrhage (vitreous, choroidal, or retinal) with warfarin and NOACs (including dabigatran, rivaroxaban, apixaban) from the World Health Organ...

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Published in:	Eye (London) 2017-04, Vol.31 (4), p.628-631
Main Authors:	Talany, G, Guo, M, Etminan, M
Format:	Article
Language:	eng
Subjects:	Anticoagulants - administration & dosage Anticoagulants - adverse effects Anticoagulants - pharmacokinetics Clinical Study Dabigatran - adverse effects Dabigatran - pharmacokinetics Eye Hemorrhage - chemically induced Eye Hemorrhage - prevention & control Humans Ocular Hypertension - chemically induced Odds Ratio Pyrazoles - adverse effects Pyrazoles - pharmacokinetics Pyridones - adverse effects Pyridones - pharmacokinetics Risk Factors Rivaroxaban - adverse effects Rivaroxaban - pharmacokinetics Stroke - drug therapy Stroke - prevention & control Warfarin - adverse effects Warfarin - pharmacokinetics
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Summary:	PurposeTo assess the risk of intraocular hemorrhage with warfarin and new oral anticoagulants (NOACs).MethodsWe ascertained all reported cases of intraocular hemorrhage (vitreous, choroidal, or retinal) with warfarin and NOACs (including dabigatran, rivaroxaban, apixaban) from the World Health Organizations's Vigibase database from 1968-2015. We used a disproportionality analysis to compute reported odds ratios (RORs) and corresponding 95% confidence by comparing the number of events with the study outcomes and study drugs compared with all other drugs reported to Vigibase. A harmful signal was deemed for a lower limit of the 95% confidence interval above 1.ResultsWe identified 80 cases of intraocular hemorrhage (vitreous, choroidal, or retinal) with warfarin in the World Health Organizations's Vigibase database from 1968-2015. A total of 156 cases of intraocular hemorrhage with NOACs (82 with rivaroxaban, 65 with dabigatran, 9 with apixaban). Warfarin had the highest signal of association with choroidal hemorrhage (ROR= 65.40 (33.86-126.30)). Rivaroxaban had the highest signal of association with both retinal and vitreous hemorrhage (ROR=7.41 (5.73-9.59) and ROR= 11.14 (7.37-16.86), respectively). Dabigatran was also significantly associated with retinal and vitreous hemorrhage (ROR= 3.78 (2.82-5.08) and ROR= 5.83 (3.66-9.30), respectively). The number of reports of retinal and vitreous hemorrhage were also significantly higher with apixaban, but the number of cases may be too little to make a meaningful evaluation.ConclusionA signal for risk of intraocular hemorrhage was detected for warfarin, dabigatran, and rivaroxaban. Large epidemiologic studies are needed to further confirm these findings.
ISSN:	0950-222X 1476-5454