Analysis of interstitial lung disease in pharmacovigilance databases: Coding challenges and interpretation biases—An update

AIM: Clinically, interstitial lung disease (ILD) is a heterogeneous group of respiratory disorders. Due to their low incidence, pharmacovigilance database analysis is useful to detect them. Precise diagnosis is challenging as well as coding in these databases. Query criteria are among the key elements for a good signal detection. This study aimed to investigate interpretation biases related to ILD coding in PV databases. METHODS: MedDRA Preferred Terms (PT) included in the broad Standardized MedDRA Query (SMQ) 'ILD' for the top five known pneumotoxic drugs was described in VigiBase by reporting year (2000-2024), country, and reporter type. Then, a systematic literature review was conducted to identify PV studies using disproportionality analyses to detect drug-induced ILD reporting signals, assessing query strategies, analysis units, and bias consideration. RESULTS: The most frequently implicated known pneumotoxic drugs were amiodarone, methotrexate, nivolumab, pembrolizumab, and everolimus. On average per year, the PTs 'ILD' represented