Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS)
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...
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Frontiers Media S.A.
2022-11-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.1017889/full |
| _version_ | 1811307987550076928 |
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| author | Pan Ma Xinmei Pan Ruixiang Liu Ya Qu Linli Xie Jiangchuan Xie Liya Cao Yongchuan Chen |
| author_facet | Pan Ma Xinmei Pan Ruixiang Liu Ya Qu Linli Xie Jiangchuan Xie Liya Cao Yongchuan Chen |
| author_sort | Pan Ma |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T09:15:07Z |
| format | Article |
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| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-13T09:15:07Z |
| publishDate | 2022-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-0e8ece31767b4a37b50156d80a7e9c6a2022-12-22T02:52:45ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-11-011310.3389/fphar.2022.10178891017889Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS)Pan Ma0Xinmei Pan1Ruixiang Liu2Ya Qu3Linli Xie4Jiangchuan Xie5Liya Cao6Yongchuan Chen7Department of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, ChinaDepartment of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, ChinaDepartment of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, ChinaSouthwest Hospital/Southwest Eye Hospital, Third Military Medical University (Army Medical University), Chongqing, ChinaDepartment of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, ChinaDepartment of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, ChinaDepartment of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, ChinaDepartment of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, ChinaBackground: 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.https://www.frontiersin.org/articles/10.3389/fphar.2022.1017889/fulladverse eventspharmacovigilanceranibizumabafliberceptbrolucizumabsafety signals |
| spellingShingle | Pan Ma Xinmei Pan Ruixiang Liu Ya Qu Linli Xie Jiangchuan Xie Liya Cao Yongchuan Chen Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS) Frontiers in Pharmacology adverse events pharmacovigilance ranibizumab aflibercept brolucizumab safety signals |
| title | Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS) |
| title_full | Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS) |
| title_fullStr | Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS) |
| title_full_unstemmed | Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS) |
| title_short | Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS) |
| title_sort | ocular adverse events associated with anti vegf therapy a pharmacovigilance study of the fda adverse event reporting system faers |
| topic | adverse events pharmacovigilance ranibizumab aflibercept brolucizumab safety signals |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.1017889/full |
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