| アブストラクト | OBJECTIVE: To evaluate post-marketing ocular adverse events (oAEs) associated with fibroblast growth factor receptor inhibitors (FGFRi). DESIGN: Population-based pharmacovigilance study. PARTICIPANTS: Ocular AE reports from the US Food and Drug Administration Adverse Event Reporting System (FAERS) for individuals treated with erdafitinib, pemigatinib, or futibatinib. METHODS: FAERS data from April 19, 2019 to June 30, 2025 were analyzed using OpenVigil 2.1. Disproportionality analyses were conducted to calculate reporting odds ratios (RORs) for drug-oAE pairs compared with all other drugs. MAIN OUTCOME MEASURES: Disproportionality of reported ocular AEs among erdafitinib, pemigatinib, and futibatinib. RESULTS: A total of 1,582 FGFR inhibitor-associated adverse events were identified, of which 200 (12.6%) were ocular. Erdafitinib accounted for the majority of ocular adverse events (75%), followed by pemigatinib (22%) and futibatinib (3%). The oAEs reported with the highest disproportionality signal with erdafitinib included corneal thinning (ROR 321; 95% CI 102-1009), ocular toxicity (ROR 225; 95% CI 117-439), and xerophthalmia (ROR 138; 95% CI 44-432). The oAEs with the greatest disproportionality signals with pemigatinib were serous retinal detachment (ROR 180; 95% CI 67-484), subretinal fluid (ROR 165; 95% CI 68-398), and retinal pigment epithelium detachment (ROR 110; 95% CI 35-344). Only one oAE was reported for futibatinib, which was dry eye (ROR 36.12; 95% CI 15.76-82.74). CONCLUSION: This pharmacovigilance analysis identified oAEs associated with FGFR inhibitors in real-world use, extending beyond those reported in clinical trials and regulatory labeling. However, findings are hypothesis-generating and reflect disproportional reporting rather than incidence or causal risk. |
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| 投稿者 | Osba, Abdelrahman Abu; Ahmad, Syed; Osba, Roaa Abu; Hendy, Abd El Aziz; Bondok, Mostafa; Mihalache, Andrew; Kohly, Radha P; Wong, David; Muni, Rajeev H; Popovic, Marko M |
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| 組織名 | Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.;Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.;Section of Ophthalmology, University of Calgary, Calgary, Alberta, Canada.;Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.;Department of Ophthalmology & Visual Sciences, University of Toronto, Toronto,;Ontario, Canada; John and Liz Tory Eye Centre, Sunnybrook Health Sciences Centre,;Toronto, Ontario, Canada; Kensington Vision and Research Institute, Toronto,;Ontario, Canada.;Ontario, Canada; Department of Ophthalmology, St. Michael's Hospital, Unity;Health Toronto, Toronto, Ontario, Canada.;Ontario, Canada; Kensington Vision and Research Institute, Toronto, Ontario,;Canada; Department of Ophthalmology, St. Michael's Hospital, Unity Health;Toronto, Toronto, Ontario, Canada.;Ontario, Canada. Electronic address: marko.popovic@mail.utoronto.ca. |
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