Abstract
Purpose :
To quantify the risk of intraocular hemorrhage with warfarin and new oral anticoagulants (NOACs).
Methods :
We ascertained all reported cases of intraocular hemorrhage (vitreous, choroidal, or retinal) with warfarin and NOACs (including dabigatran, rivaroxaban and 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 to all other drugs reported to Vigibase. A harmful signal was deemed for a lower limit of the 95% confidence interval above 1.
Results :
We identified 100 cases of intraocular hemorrhage (vitreous, choroidal, or retinal) with warfarin in the World Health Organizations’s Vigibase database from 1968-2015. A total of 171 cases of intraocular hemorrhage with NOACs (93 cases with rivaroxaban, 69 with dabigatran, and 9 with apixaban). Warfarin had the highest association with choroidal hemorrhage (ROR= 65.40 [33.86 – 126.30]). Rivaroxaban had the highest 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.
Conclusions :
Warfarin, dabigatran, and rivaroxaban showed a significant association with various types of intraocular hemorrhage. Large epidemiologic studies are needed to further confirm these findings.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.