Post-marketing safety signals of imatinib: pharmacovigilance insights from the FDA Adverse Event Reporting System (FAERS) and implications for clinical practice.

Abstract

Aims: To evaluate the safety profile of imatinib using the FDA Adverse Event Reporting System (FAERS) database, identifying both documented and undocumented adverse events.

Methods: The FAERS data is widely used in drug safety surveillance studies, helping to identify potential safety issues. The FAERS data, spanning from the first quarter of 2014 to the fourth quarter of 2024, were subjected to a comprehensive analysis utilizing various disproportionality analysis methods. These methods included the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM). The primary objective of this analysis was to quantify the associations between specific drugs and their corresponding adverse events (AEs). By employing these advanced statistical techniques, we aimed to identify and evaluate potential safety signals within the vast dataset, thereby providing valuable insights into the pharmacovigilance landscape over the specified decade.

Results: A total of 56,364 reports (170,659 AE occurrences) were included. Imatinib exhibited expected AEs (e.g., nausea, diarrhea) consistent with summaries of product characteristics (SPCs), alongside potential novel signals such as pubertal failure, large intestine fibroma, ototoxicity, and pregnancy complications. Severe outcomes comprised 84.24% of reports (34.44% death), with 38.08% of AEs occurring > 360 days post-treatment. Malignant neoplasm progression showed a strong association.

Conclusions: This study has revealed the safety issues of imatinib, particularly in terms of gastrointestinal reactions. It emphasizes the need for careful monitoring and further research in clinical applications to understand the mechanism, improve treatment efficacy, and minimize adverse events.