| アブストラクト | OBJECTIVE: To evaluate postmarketing 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 for individuals treated with erdafitinib, pemigatinib, or futibatinib. METHODS: US Food and Drug Administration Adverse Event Reporting System data from April 19, 2019 to June 30, 2025 were analyzed using OpenVigil 2.1. Disproportionality analyses were conducted to calculate reporting odds ratios 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 1582 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 1 oAE was reported for futibatinib, which was dry eye (ROR 36.12; 95% CI 15.76-82.74). CONCLUSIONS: 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 | Abu Osba, Abdelrahman; Ahmad, Syed; Abu Osba, Roaa; 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 | From the Faculty of Medicine (A.A.O., S.A., A.E.A.H.), Dalhousie University,;Halifax, Nova Scotia, Canada.;Leslie Dan Faculty of Pharmacy (R.A.O.), University of Toronto, Toronto, Ontario,;Canada.;Section of Ophthalmology (M.B.), University of Calgary, Calgary, Alberta, Canada.;Faculty of Medicine (A.M.), University of Toronto, Toronto, Ontario, Canada.;Department of Ophthalmology & Visual Sciences (R.P.K., D.W., R.H.M., M.M.P.),;University of Toronto, Toronto, Ontario, Canada; John and Liz Tory Eye Centre;(R.P.K.), Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Kensington;Eye Institute, Kensington Vision and Research Institute (R.P.K., R.H.M.),;Toronto, Ontario, Canada.;University of Toronto, Toronto, Ontario, Canada; Department of Ophthalmology;(D.W., M.M.P.), St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario,;University of Toronto, Toronto, Ontario, Canada; Kensington Eye Institute,;Kensington Vision and Research Institute (R.P.K., R.H.M.), Toronto, Ontario,;Canada; Department of Ophthalmology (D.W., M.M.P.), St. Michael's Hospital, Unity;Health Toronto, Toronto, Ontario, Canada.;University of Toronto, Toronto, Ontario, Canada. Electronic address:;marko.popovic@mail.utoronto.ca. |
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