Reporting on Adverse Clinical Events

Abstract

A retrospective review of data from the Japanese Adverse Drug Event Report (JADER) was performed to evaluate ocular adverse events reported with antineoplastics from April 2004 to April 2021. Eight types of ocular adverse events were included in the search: periorbital and eyelid, conjunctival, corneal, scleral, lacrimal, lens, retinal, and optic nerve disorders. Reporting odds ratios (RORs) were determined using these disorders. For periorbital and eyelid disorders, safety signals were detected only with imatinib mesilate (ROR = 4.61 [2.85-7.46]). For conjunctival disorders, safety signals were noted for imatinib mesilate (ROR = 3.14 [1.85-5.32]) and lapatinib tosilate hydrate (ROR = 6.13 [2.91-12.94]). Eight drugs were associated with increased RORs for corneal disorders, including S-1, erlotinib, capecitabine, cetuximab, gefitinib, vandetanib, trastuzumab emtansine, and lapatinib. No antineoplastics were associated with safety signals for scleral disorders. For lacrimal disorders, safety signals were detected with S-1 (ROR = 41.41 [34.62-49.53]) and pembrolizumab (ROR = 2.45 [1.44-4.16]). For lens disorders, several chemotherapy agents were associated with increased RORs, including lenalidomide, pomalidomide, elotuzumab, tamoxifen, bexarotene, and venetoclax. Further analysis revealed that some antineoplastics were associated with increased RORs based on sex and age. Based on the results of this retrospective analysis of data in the JADER database, the authors concluded that several anticancer drugs may be associated with increased safety signals for ocular adverse events, some of which were not readily recognized. The authors noted that these results may be helpful in predicting the occurrence of ocular adverse events by onclogists. Antineoplastics [Imatinib, Lapatinib, S-1, Erlotinib, Capecitabine, Cetuximab, Gefitinib, Vandetanib, Trastuzumab, Emtansine] Tanaka J et al (Takenao Koseki: Department of Clinical Pharmacy, Fujita Health University School of Medicine 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan; e-mail: tkoseki@ fujita-hu.ac.jp) Analyses of ocular adverse reactions associated with anticancer drugs based on the Japanese pharmacovigilance database. Anticancer Res 42:4439–4451 (Sep) 2022