Tyrosine Kinase Inhibitors and Interstitial Lung Disease: A Disproportionality Analysis Using the European Post-marketing EudraVigilance Database.

ABSTRACT:

Background

Increasing global frequency of drug-induced interstitial lung disease (ILD) coincides with increasing market introduction of tyrosine kinase inhibitors (TKIs).

Objectives

The aim was to detect disproportional reporting of TKI-induced ILD in the EudraVigilance post-marketing safety database and to scrutinise the prescribing information of these TKIs.

Methods

Data were gathered on the number of total and individual ILD case safety reports for each TKI marketed in the European Union (EU), together with indications and patient demographics. Information was also obtained on numbers of total and ILD reports for all drugs in the entire database, covering the period January 2002 to March 2024. Chi-squared analyses and two measures of disproportionality, the proport

SUBMITTER: Shah DR 

PROVIDER: S-EPMC12634963 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature