A disproportionality analysis of interstitial lung disease associated with drug therapy in spontaneous adverse event reports.

BACKGROUND

Interstitial lung disease (ILD) is a group of disorders characterized by inflammation and fibrosis of lung tissue that make it hard to carry oxygen. Our study aimed to comprehensively evaluate the risk of drug-induced ILD using data from the FDA Adverse Event Reporting System (FAERS) database.

RESEARCH DESIGN AND METHODS

We queried the ILD reports from 2004 to 2023. The reporting odds ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) were calculated to detect disproportionality signals for drugs associated with ILD.

RESULTS

A total of 39,332 ILD-related reports were identified. The most frequently reported drugs were Methotrexate ( = 1245), followed by Pembrolizumab ( = 1026), Amiodarone ( = 975), Rituximab ( = 915), and Doxorubicin ( = 911). Disproportionality analysis revealed significant signals for the top 50 drugs, including Trastuzumab deruxtecan (ROR 56.25, 95% CI 51.27-61.72; IC025 5.49), Ramucirumab (ROR 27.80, 95% CI 241.6-31.99; IC025 4.50), Amiodarone (ROR 24.35, 95% CI 22.82-25.99; IC025 4.40), Gefitinib (ROR 23.02, 95% CI 20.66-25.66; IC025 4.29), and Doxorubicin (ROR 13.99, 95% CI 13.09-14.95; IC025 3.64).

CONCLUSIONS

Drug-induced ILD represents a significant challenge in clinical practice. Our findings underscore the importance of maintaining a high index of suspicion for drug-induced ILD, particularly when prescribing medications identified as having significant associations with ILD.