Primary suspect drugs of cataracts in pediatric patients: FDA adverse events reporting database analysis

To identify primary suspect drugs potentially associated with pediatric cataracts by analyzing reports from the Food and Drug Administration Adverse Event Reporting System (FAERS).

Database study.

Retrospective observational pharmacovigilance study.

FAERS reports submitted between 2004 and 2024 involving patients aged 18 years or younger 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 5 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.

The mean patient age was 9.39 ± 4.59 years. 91 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, χ 2 = 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, χ 2 = 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, χ 2 = 204.17, ROR 95% CI: 9.89 [6.76-14.46], EBGM [EBGM05]: 3.39 [2.36], IC [IC05]: 3.01 [2.45]).

3 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.