Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS)

Abstract

Background: The purpose of this study is to identify and characterize ocular adverse events (AEs) that are significantly associated with anti-VEGF drugs for treatment of neovascular age-related macular degeneration and compare the differences between each drug, and provide clinical reference.Methods: Ocular AEs submitted to the US Food and Drug Administration were analyzed to map the safety profile of anti-VEGF drugs. The Pharmacovigilance tools used for the quantitative detection of signals were reporting odds ratio and bayesian confidence propagation neural network.Results: A total of 10,608,503 AE reports were retrieved from FAERS, with 20,836 for ranibizumab, 19,107 for aflibercept, and 2,442 for brolucizumab between the reporting period of Q1, 2004 and Q3, 2021. We found and analyzed the different AEs with the strongest signal in each drug—ranibizumab-macular ischaemia (ROR = 205.27, IC-2SD = 3.70), retinal pigment epithelial tear (ROR = 836.54, IC-2SD = 7.19); aflibercept-intraocular pressure increased (ROR = 31.09, IC-2SD = 4.61), endophthalmitis (ROR = 178.27, IC-2SD = 6.70); brolucizumab-retinal vasculitis (ROR = 2930.41, IC-2SD = 7.47) and/or retinal artery occlusion (ROR = 391.11, IC-2SD = 6.10), dry eye (ROR = 12.48, IC-2SD = 2.88).Conclusion: The presence of AEs should bring clinical attention. The use of anti-VEGF drugs should be based on the patient’s underlying or present medical condition to reduce any adverse event associated with the treatment.

Real-World Analysis of Medications Inducing Meibomian Gland Dysfunction: based on the FDA adverse event reporting system database

“…While the likelihood of systemic adverse reactions with ranibizumab is generally minimal, this risk escalates in older patients [33,34]. A study based on the FAERS database indicated a strong positive signal for dry eye disease as an adverse reaction induced by ranibizumab [35], but no study has yet shown a correlation between ranibizumab and MGD, nor is its mechanism of action and development clear.…”

Cardioprotective effects of Platycodon grandiflorum Granules in HER2-positive early breast cancer patients receiving Trastuzumab plus Pertuzumab: study protocol for a double blind randomized controlled trial

“…Although the mechanism by which trastuzumab and pertuzumab induces cardiotoxicity remains unclear, the HER-2 signaling pathway plays a signi cant role in the embryonic development and maintenance of normal cardiac function [14,15]. Trastuzumab and pertuzumab exerts an antagonistic effect on the HER-2 receptor, which may affect the stress response, damage repair, and survival status of myocardial cells, thereby exacerbating cardiac toxicity [16][17][18].…”

25-hydroxyvitamin D3 inhibits oxidative stress and ferroptosis in retinal microvascular endothelial cells induced by high glucose through down-regulation of miR-93

“…Usui-Ouchi et al showed that intra-vitreal injection of the CITED2 peptide inhibited retinal NV by down-regulation of HIF-mediated transcription in retinal cells [ 29 ]. However, the adverse effects after the administration of high-dose anti-VEGF drugs can not be ignored [ 30 ]. It’s necessary to find alternative drugs without adverse effects to treat DR.…”

“…Currently, [29]. However, the adverse effects after the administration of high-dose anti-VEGF drugs can not be ignored [30]. It's necessary to find alternative drugs without adverse effects to treat DR.…”