Drug-induced tubulointerstitial nephritis and uveitis syndrome in a nationwide surveillance

To investigate primary suspect drugs and identify a potential association between medication use and Tubulointerstitial Nephritis and Uveitis (TINU).

A retrospective pharmacovigilance study was conducted using the Food and Drug Administration (FDA) Adverse Events Database (FAERS) from Q1 2004 to Q2 2024, focusing on patient demographics and statistical signal detection. A qualitative analysis assessed patient demographics. To ascertain if these reports yielded statistically significant signals, we used the proportional reporting ratio (PRR), chi-squared with Yates' correction (χ²), reporting odds ratio (ROR), empirical Bayes geometric mean (EBGM), and information component (IC).

One hundred twenty-six adverse reports for TINU were identified, along with 37 primary suspect drugs from the FAERS database. The mean age of patients was 30.05 ± 20.88 years. Most reports were of female patients (n = 67, 53%). Of the 37 primary suspect drugs, lamotrigine (n = 35, 27%) and diclofenac (n = 15, 12%) were the most frequently reported suspect drugs. The signal detection analysis also identified positive signals and potential causality for both drugs. Lamotrigine demonstrated the strongest positive signal (PRR = 90.09, χ2 = 3001.58, ROR 95% CI: 124.35 [84.20-183.66], EBGM [EBGM05]: 70.98 [50.21], IC [IC05]: 5.32 [4.83]), followed by diclofenac (PRR = 24.21, χ2 = 312.49, ROR 95% CI: 27.35 [15.95-46.90], EBGM [EBGM05]: 4.11 [2.47], IC [IC05]: 3.79 [2.99]).

Our study identified 37 primary suspect drugs associated with TINU, with lamotrigine and diclofenac showing the strongest statistical signals. Lamotrigine demonstrated the highest association, suggesting a potential drug-related risk for developing TINU, particularly in younger patients and females. Further research is warranted to explore causality and underlying mechanisms in these associations.