Study Identifies Meds Linked to Pediatric Cataract Development

Pediatric cataracts have the potential to cause lifelong visual problems if unattended to. Routine screening is needed in children requiring many forms of systemic therapy. Photo: Marc Myers, OD. Click image to enlarge. Pharmacovigilance—the detection and analysis of adverse drug effects in real-world scenarios subsequent to FDA approval—may help determine the effects of pediatric cataracts and treatment of the condition. Researchers in China analyzed data from the FDA Adverse Event Reporting System (FAERS), a database of drug-related adverse effects, spanning 21 years. As they explained in their paper for a journal called Children, “While drug-induced cataracts are a well-documented adverse event (AE) in adults, the pediatric risk profile remains insufficiently characterized due to the exclusion of children from most clinical trials.” Among 690,347 screened pediatric cases, 671 reports documented cataracts in patients up to age 17. The reports originated from various countries, with the US contributing the most at 222 cases, followed by Canada with 66 and the UK with 43. There were “no statistically significant differences” between male and female patients, and age demographics showed that over half of the affected patients (322 in total) fell into the six- to 13-year group, while 204 were between ages 14 and 17,  and 340 were six years and under. The researchers described outcomes as “generally poor,” with 12 deaths and 400 cases classified as other serious medical events. Among the 232 drugs in studied cataract reports, 102 unique ones underwent analysis and signals were identified in 24. Glucocorticoids were a dominating group with 11 drugs and 99 cases, including prednisolone (18 reports), prednisone (17) and triamcinolone acetonide (13). They were followed by monoclonal antibodies, with 55 reports related to adalimumab, and immunosuppressants like methotrexate (43) and mycophenolate mofetil (16). “Additionally,” noted the authors in their paper, “cystic fibrosis-targeted therapies such as elexacaftor/ivacaftor/tezacaftor (19 reports), ivacaftor/lumacaftor (15 reports), and ivacaftor (14 reports) were identified,” as well as “antineoplastic agents melphalan (12 reports), topotecan (8 reports), and cisplatin (3 reports).” In addition, the antiepileptic drug topiramate was associated with 11 reports, according to the paper.Drugs were administered to patients using a variety of administration routes, such as intra-arterial and intravitreal methods; the authors discussed the detriments of certain methods over others, such as the aforementioned routes “expos[ing] the crystalline lens to high local concentrations of cytotoxic agents.” The study also brought attention to “under-recognized” risks in off-label pediatric prescriptions, as pediatric eyes that are not yet developed like adult eyes have “immature blood-ocular barriers and mitotic lens cells,” which may put them at greater risk of adverse drug reactions. Click here for the journal source. Du J, Xing C, Zhang Z, et al. Drugs associated with pediatric cataracts: a real-world pharmacovigilance study. Children. February 9, 2026. [Epub ahead of print.] This article was developed by the editorial staff in conjunction with experts in the field. In the process, AI may have been among the editorial tools used to meet the goals of human editors, who approved all content.