Primary Suspect Drugs of Cataracts in Pediatric Patients: An FDA Adverse Events Reporting Database Analysis

Purpose: To identify primary suspect drugs potentially associated with pediatric cataracts by analyzing reports from the Food and Drug Administration Adverse Event Reporting System (FAERS). Setting: Database study. Design: Retrospective observational pharmacovigilance study. Methods: FAERS reports submitted between 2004 and 2024 involving patients ≤18 years with adverse events listed as cataract and its subtypes. Descriptive statistics summarized patient demographics and drug reporting frequencies. A signal detection analysis was conducted using five established data mining algorithms: proportional reporting ratio (PRR), chi-squared with Yates' correction (χ 2 ), reporting odds ratio (ROR), empirical Bayes geometric mean (EBGM), and information component (IC). Positive signals were defined using threshold criteria established in pharmacovigilance literature. Results: The mean patient age was 9.39 ± 4.59 years. Ninety-one drugs were listed as primary suspect drugs. The most frequently reported drugs were ivacaftor and prednisolone (n=29, 7%), followed by methotrexate and adalimumab (n=26, 6%). Topotecan demonstrated the strongest positive signal (n=12, PRR=47.34, χ2=477.86, ROR 95% CI: 48.84 [27.15-87.86], EBGM [EBGM05]: 18.13 [9.8], IC [IC05]: 4.03 [3.11]), followed by ivacaftor (n=29, PRR=12.04, χ2=281.28, ROR 95% CI: 12.95 [8.85-18.94], EBGM [EBGM05]: 5.46 [3.78], IC [IC05]: 3.33 [2.77]), and prednisolone (n=29, PRR=9.22, χ2=204.17, ROR 95% CI: 9.89 [6.76-14.46], EBGM [EBGM05]: 3.39 [2.36], IC [IC05]: 3.01 [2.45]). Conclusion: Three potential drug-adverse event pairs were identified for pediatric cataracts, including a previously infrequently described association with ivacaftor and topotecan. Prednisolone, consistent with known corticosteroid-induced cataractogenesis, also demonstrated a positive signal. These findings raise drug safety concerns and warrant further investigation.