Risk of intraocular hemorrhage with new oral anticoagulants

Association of Novel Oral Antithrombotics With the Risk of Intraocular Bleeding

“…This type of information can be misleading because it is susceptible to reporting bias and lacks the ability to control for confounding factors or to properly quantitate risk since the total number of prescriptions represented is unknown. 17 Although our results are similar to those reported in the meta-analysis by Sun et al, 22 it is important to differentiate how each study arrived at its conclusions. Our study focuses on real-world use of anticoagulants, whereas the metaanalysis focused on results from clinical trial populations that may differ from our study in terms of baseline bleeding risk and how the drugs are dosed and monitored.…”

“…Our results, along with the recent meta-analysis of clinical trial data by Sun et al 22 contradict the concerns for intraocular bleeding raised by case reports [12][13][14][15][16]18 and the World Health Organization adverse events database analysis. 17 Information in the World Health Organization adverse events database results is based solely on voluntary reporting. This type of information can be misleading because it is susceptible to reporting bias and lacks the ability to control for confounding factors or to properly quantitate risk since the total number of prescriptions represented is unknown.…”

“…Other strengths of our study should be noted, including our ability to assess many other nonophthalmic factors that could mitigate or potentiate the effects of anticoagulants that may have been an issue in previous studies. In addition, the cohort design of the study minimizes the potential bias of convenience sampling that frequently occurs in case reports (and, by extension, the World Health Organization report 17 ) when rare outcomes spur publications that do not reflect the true rate seen in a larger population. Last, pharmacy records, not patient reports, determined medication use; thus, recall bias was eliminated.…”

“…[9][10][11][12][13][14][15][16] An analysis using the World Health Organization's database of adverse events suggests that the odds of having a retinal or vitreous hemorrhage while taking dabigatran or rivaroxaban far exceeds that of warfarin. 17 However, the results of this study are based strictly on voluntary physician report and do not quantify the number of patients using the medication. Contrasting these findings is a meta-analysis that found no increased risk of intraocular bleeding in patients taking novel anticoagulants vs those taking vitamin K antagonists, but this analysis was not geared toward finding eye complications.…”

Efficacy and safety of non-vitamin K-antagonist oral anticoagulants for retinal vascular diseases in patients with atrial fibrillation: Korean cohort study

“…Previous studies have reported that there is an increased risk of intraocular bleeding with warfarin or other oral antithrombotics, raising concerns over the safety of these medications 9 . Hence, several studies on ocular diseases have examined the impact of anticoagulant therapy with NOAC, with a focus on ocular bleeding as a major safety issue [9][10][11] . While NOACs benefit patients with stroke and systemic thromboembolisms 12 , their efficacy on microvascular conditions, such as retinal vascular occlusion, requires further evaluation.…”