Data-mining and Analysis of Adverse Events Signals for Aromatase Inhibitors Based on FAERS Database

OBJECTIVE To provide reference for safe and rational drug use in clinic by mining and analysis of adverse drug event(ADE) signals of aromatase inhibitors(AIs). METHODS Data of ADE reports related to AIs in the first quarter of 2015 to second quarter of 2021 included 26 quarterlies were collected from US FDA adverse event reporting system. After data standardization, the reporting odd ratio method and the proportional reporting ratio method were used for ADE signal screening and analysis. RESULTS A total of 16 501 ADE reports with AIs as the primary suspected drug were extracted. The 1 150 effective ADE signals(exemestane 209, letrozole 377 and anastrozole 564) were obtained after screening, involving 23 systems organ classes and mainly focusing on various musculoskeletal and connective tissue diseases, systemic diseases and various reactions of drug administration sites and so on. In the sequence of top 50, there were 47 signals that did not appear in the instruction, including exemestane 15, letrozole 11 and anastrozole 21, and the new signals were concentrated in the blood, cardiovascular and respiratory systems. CONCLUSION The common ADE signals and involved systems obtained in study are consistent with the instructions. However, ADE of the three AIs are different and new signals are found, which can provide certain reference for clinical rational drug use.