A disproportionality analysis of cardiac arrhythmia associated with bisphosphonates based on the FAERS database

Abstract The impact of bisphosphonates on cardiac arrhythmia has always been controversial. We aimed to evaluate the risk of bisphosphonates (BPs) on arrhythmia and to characterize the main features of BP-induced arrhythmia by data mining the FDA adverse event Reporting System (FAERS). From the firs...

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Main Authors: Feifei Wang, Guishui Xu, Qian Wang, Xinan Wu
Format: Article
Language:English
Published: Nature Portfolio 2025-07-01
Series:Scientific Reports
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Online Access:https://doi.org/10.1038/s41598-025-00900-y
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author Feifei Wang
Guishui Xu
Qian Wang
Xinan Wu
author_facet Feifei Wang
Guishui Xu
Qian Wang
Xinan Wu
author_sort Feifei Wang
collection DOAJ
description Abstract The impact of bisphosphonates on cardiac arrhythmia has always been controversial. We aimed to evaluate the risk of bisphosphonates (BPs) on arrhythmia and to characterize the main features of BP-induced arrhythmia by data mining the FDA adverse event Reporting System (FAERS). From the first quarter of 2016 to the second quarter of 2022, reports for BP-related cardiac arrhythmia adverse event (AE) from FAERS database were analyzed in this study. The reporting odds ratio (ROR) and information components (IC) were used to identify disproportionate reporting of BP-related cardiac arrhythmias. We identified a total of 2377 BP-related cardiac arrhythmias cases which appeared to influence more women (61.88%) than men (28.02%), with a median age of 70 (interquartile range [IQR] 59–78) years. Compared with the full database, BPs were detected with pharmacovigilance of cardiac arrhythmias (ROR025 = 1.43, [1.39–1.47]). All studied bisphosphonates except ibandronate sodium and clodronate disodium were correlated with the reporting frequency of cardiac arrhythmia (HLGT), with ROR ranging from 1.28 with pamidronate disodium to 11.08 with etidronate disodium. The spectrum of arrhythmias induced by BPs differed among therapeutic regimens. There were significant differences in the onset time among BP regimens. Bisphosphonates use is associated with adverse cardiac arrhythmias, with the exception of ibandronate sodium and clodronate disodium. Our data support differential effects of BPs on cardiac arrhythmias.
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spelling doaj-art-aac20f9eaf6646e2a42bd0abed1af35b2025-08-20T03:38:15ZengNature PortfolioScientific Reports2045-23222025-07-011511810.1038/s41598-025-00900-yA disproportionality analysis of cardiac arrhythmia associated with bisphosphonates based on the FAERS databaseFeifei Wang0Guishui Xu1Qian Wang2Xinan Wu3Department of Pharmacy, Hefei BOE HospitalOrthopaedic Department of the First People’s Hospital of AnqingDepartment of Pharmacy, Hefei BOE HospitalDepartment of Pharmacy, Hefei BOE HospitalAbstract The impact of bisphosphonates on cardiac arrhythmia has always been controversial. We aimed to evaluate the risk of bisphosphonates (BPs) on arrhythmia and to characterize the main features of BP-induced arrhythmia by data mining the FDA adverse event Reporting System (FAERS). From the first quarter of 2016 to the second quarter of 2022, reports for BP-related cardiac arrhythmia adverse event (AE) from FAERS database were analyzed in this study. The reporting odds ratio (ROR) and information components (IC) were used to identify disproportionate reporting of BP-related cardiac arrhythmias. We identified a total of 2377 BP-related cardiac arrhythmias cases which appeared to influence more women (61.88%) than men (28.02%), with a median age of 70 (interquartile range [IQR] 59–78) years. Compared with the full database, BPs were detected with pharmacovigilance of cardiac arrhythmias (ROR025 = 1.43, [1.39–1.47]). All studied bisphosphonates except ibandronate sodium and clodronate disodium were correlated with the reporting frequency of cardiac arrhythmia (HLGT), with ROR ranging from 1.28 with pamidronate disodium to 11.08 with etidronate disodium. The spectrum of arrhythmias induced by BPs differed among therapeutic regimens. There were significant differences in the onset time among BP regimens. Bisphosphonates use is associated with adverse cardiac arrhythmias, with the exception of ibandronate sodium and clodronate disodium. Our data support differential effects of BPs on cardiac arrhythmias.https://doi.org/10.1038/s41598-025-00900-yBisphosphonatesCardiac arrhythmiasAdverse eventFAERSPharmacovigilance
spellingShingle Feifei Wang
Guishui Xu
Qian Wang
Xinan Wu
A disproportionality analysis of cardiac arrhythmia associated with bisphosphonates based on the FAERS database
Scientific Reports
Bisphosphonates
Cardiac arrhythmias
Adverse event
FAERS
Pharmacovigilance
title A disproportionality analysis of cardiac arrhythmia associated with bisphosphonates based on the FAERS database
title_full A disproportionality analysis of cardiac arrhythmia associated with bisphosphonates based on the FAERS database
title_fullStr A disproportionality analysis of cardiac arrhythmia associated with bisphosphonates based on the FAERS database
title_full_unstemmed A disproportionality analysis of cardiac arrhythmia associated with bisphosphonates based on the FAERS database
title_short A disproportionality analysis of cardiac arrhythmia associated with bisphosphonates based on the FAERS database
title_sort disproportionality analysis of cardiac arrhythmia associated with bisphosphonates based on the faers database
topic Bisphosphonates
Cardiac arrhythmias
Adverse event
FAERS
Pharmacovigilance
url https://doi.org/10.1038/s41598-025-00900-y
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