Mining and analysis of adverse event signals for alendronate based on the real-world data of FDA adverse event reporting system database

Abstract

ABSTRACT Objective Our study aims to assess alendronate-related adverse events (AEs) from the US FDA adverse event reporting system database. Methods The AE data associated with alendronate between the first quarter of 2004 and the first quarter of 2024 were selected. Various signal quantification methods, including the ROR, PRR, BCPNN, and EBGM, were applied for analysis. Results In 34,943 reports where alendronate was the primary suspected drug for the AE, 24 affected system organ classes and 1046 significant preferred terms were identified in this study. Several significant AEs beyond drug instructions with strong signals were determined, including low turnover osteopathy, fracture delayed union, fracture nonunion, loss of anatomical alignment after fracture reduction, fracture malunion, periprosthetic fracture, carotid bruit, oral fibroma, traumatic occlusion, and phlebolith. The median time to onset of alendronate-related AEs was 306 days (interquartile range [IQR] 12–1,461 days), and the majority of cases occurred 2 years later (18.80%) and within 30 days (14.49%). Conclusions The current study detected multiple potential new AE signals for alendronate, and more clinical researches are required to further validate our results and clarify their associations.