Unraveling the Spectrum of Ocular Toxicity with Oxaliplatin: Clinical Feature Analysis of Cases and Pharmacovigilance Assessment of the US Food and Drug Administration Adverse Event Reporting System Database

• Published in: Clinical therapeutics 2024-12, Vol.46 (12), p.1049-1058
• Main Authors: Liu, Wensheng, Ye, Xuan, Shan, Han, Wang, Mengmeng, Wang, Yingbin, Guo, Zihan, Liu, Jiyong, Du, Qiong
• Format: Article
• Language: English
• Subjects: Adult; Adverse Drug Reaction Reporting Systems - statistics & numerical data; Adverse events; Aged; Antineoplastic Agents - adverse effects; Bayes Theorem; Bayesian analysis; Blindness; Cancer therapies; Case reports; Cataracts; Colorectal cancer; Databases, Factual; Disproportionality analysis; Edema; Epidemiology; Eye Diseases - chemically induced; Eye Diseases - epidemiology; Eyelid; FAERS; Female; Gender; Humans; Literature reviews; Male; Metastasis; Middle Aged; Ocular toxicity; Ophthalmoplegia; Optic nerve; Oxaliplatin; Oxaliplatin - adverse effects; Patients; Pharmacovigilance; Side effects; Software; Statistical analysis; Swelling; Systematic review; Thrombosis; Toxicity; United States - epidemiology; United States Food and Drug Administration
• ISSN: 0149-2918; 1879-114X; 1879-114X
• DOI: 10.1016/j.clinthera.2024.09.019

•Ocular adverse events (oAEs) associated with oxaliplatin are rare but still sporadically reported in the real world. The data regarding such events in real-world settings are limited to case reports and still lacking.•The purpose of this study was to unravel the clinical characteristics, management, and outcomes of oxaliplatin-associated oAEs in the real world by reviewing case reports as well as data from the US Food and Drug Administration Adverse Event Reporting System.•Literature review summarized cases of oxaliplatin-associated oAEs with primary clinical manifestations of loss of vision, bilateral blepharoptosis, papilledema, and optic disc swelling. Moreover, pharmacovigilance analysis uncovered 12 potential oAEs highly associated with oxaliplatin. The median time of onset for these oAEs was the first day after the administration, and most cases had serious outcomes.•Results of this study provide a vigilant reference for medical decision making regarding oxaliplatin chemotherapy regimens and can help health care providers be more aware of these events and intervene early and appropriately. Large population-based prospective studies are warranted to further explore the oAEs associated with oxaliplatin. Ocular adverse events (oAEs) are a class of adverse events associated with oxaliplatin that are realistically observed in real-world settings. Herein, we aim to describe the clinical characteristics of oAEs associated with oxaliplatin through a systematic review of case reports and to assess a potential safety signal. PubMed, Embase, and Cochrane Library databases were used to retrieve case reports. The global disproportionality study was performed leveraging the US Food and Drug Administration Adverse Event Reporting System database from January 2004 to September 2023. Bayesian information component (IC) and reporting odds ratio (ROR) were applied to identify and evaluate potential oAEs associated oxaliplatin. A total of 20 cases from the systematic case review (of 13 screened articles) were reported on oAEs associated with oxaliplatin, with ages between 26 and 76 years. Therein, 16 (84.2%) cases described loss of vision, and the remaining cases presented with bilateral blepharoptosis, papilledema, and optic disc swelling. Insights from the US Food and Drug Administration Adverse Event Reporting System database showed that oAEs accounted for 4.28% (n = 1194) of the overall oxaliplatin-related adverse event reports, of which 1140 (95.48%) had a serious