A new pharmacovigilance study using FDA adverse event data has identified several drugs potentially associated with cataract development in children.
Researchers analyzed nearly 2 decades of reports from the FDA Adverse Event Reporting System, focusing on patients 18 years or younger who were diagnosed with cataracts or related conditions.
Among 91 drugs listed as primary suspects, topotecan, ivacaftor, and prednisolone emerged with the strongest safety signals. Topotecan, a chemotherapy drug, showed the highest association strength, followed by ivacaftor, a cystic fibrosis therapy not previously well linked to cataracts, and prednisolone, a corticosteroid with an established cataract risk.
The average age of affected patients was just over 9 years.
Reference
Ali A, Dockery PW, Downes DG, et al. Primary Suspect Drugs of Cataracts in Pediatric Patients: An FDA Adverse Events Reporting Database Analysis. J Cataract Refract Surg. 2025;doi: 10.1097/j.jcrs.0000000000001738. Epub ahead of print. PMID: 40643173.
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