Sex differences of fall-risk-increasing drugs in the middle-aged and elderly: a descriptive, cross-sectional study of FDA adverse event reporting system

Abstract It’s well known that sex is a risk factor for the occurrence of adverse events (AEs), most of which have found sex differences. Real-world data studies on the sex differences of fall-risk-increasing drugs (FRIDs) are few and far between, with most small-scale retrospective studies based on...

Full description

Saved in:
Bibliographic Details
Main Authors: Ying Zhao, Yuke Zhong, Liuqing Wu, Jiao Yan, Weitao Lu
Format: Article
Language:English
Published: Nature Portfolio 2024-11-01
Series:Scientific Reports
Subjects:
Online Access:https://doi.org/10.1038/s41598-024-81342-w
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1823862193875058688
author Ying Zhao
Yuke Zhong
Liuqing Wu
Jiao Yan
Weitao Lu
author_facet Ying Zhao
Yuke Zhong
Liuqing Wu
Jiao Yan
Weitao Lu
author_sort Ying Zhao
collection DOAJ
description Abstract It’s well known that sex is a risk factor for the occurrence of adverse events (AEs), most of which have found sex differences. Real-world data studies on the sex differences of fall-risk-increasing drugs (FRIDs) are few and far between, with most small-scale retrospective studies based on FRID classes. To establish a list of FRIDs and describe their sex differences, we used preferred terms from the Medical Dictionary for Regulatory Activities to search for AEs in the FDA Adverse Event Reporting System (FAERS), and then perform disproportionality analyses and female/male ratio analyses. During January 2004 to March 2023, 101,746 fall-related AEs were reported in FAERS from patients aged 50 to 100, with 68,492 (67.3%) females and 32,547 (32.0%) males. We found 261 signals for females while 284 for males. For females, the top 3 signals with the highest reporting odds ratio (ROR) were anethole trithione, clopenthixol, nikethamide (ROR: 388.88, 212.10, 113.94), while the top 3 signals with the highest lower limit of information component (IC025) were nikethamide, anethole trithione, benzbromarone (IC025: 3.91, 3.15, 2.49). For males, the top 3 signals with the highest ROR were fluprednidene acetate, potassium hydroxide, ketazolam (ROR: 216.86, 108.43, 108.43), while the top 3 signals with the highest IC025 were clomethiazole, piribedil, melperone (IC025: 3.31, 3.24, 2.99). Moreover, among the 119 shared signals found between males and females, 33 were positively correlated with falls in females and 38 with falls in males. Signals showing significant sex differences were mainly concentrated on agents of the immune, nervous, musculo-skeletal, and cardiovascular systems. We offered a series of FRIDs and suggested their sex differences in falls through the FAERS. In the future, it is essential to balance the inclusion of women and men, and analyse sex-stratified for FRIDs.
format Article
id doaj-art-871ee5c961094ea993fd1c47bf176ae6
institution Kabale University
issn 2045-2322
language English
publishDate 2024-11-01
publisher Nature Portfolio
record_format Article
series Scientific Reports
spelling doaj-art-871ee5c961094ea993fd1c47bf176ae62025-02-09T12:38:23ZengNature PortfolioScientific Reports2045-23222024-11-0114111110.1038/s41598-024-81342-wSex differences of fall-risk-increasing drugs in the middle-aged and elderly: a descriptive, cross-sectional study of FDA adverse event reporting systemYing Zhao0Yuke Zhong1Liuqing Wu2Jiao Yan3Weitao Lu4Shenzhen Longgang Central HospitalShenzhen Longgang Central HospitalShenzhen Longgang Central HospitalDepartment of Respiratory Medicine, Traditional Chinese Medicine Innovation Research Center, Shenzhen Hospital of Integrated Traditional Chinese and Western MedicineDepartment of Pharmacy, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Sun Yat-sen UniversityAbstract It’s well known that sex is a risk factor for the occurrence of adverse events (AEs), most of which have found sex differences. Real-world data studies on the sex differences of fall-risk-increasing drugs (FRIDs) are few and far between, with most small-scale retrospective studies based on FRID classes. To establish a list of FRIDs and describe their sex differences, we used preferred terms from the Medical Dictionary for Regulatory Activities to search for AEs in the FDA Adverse Event Reporting System (FAERS), and then perform disproportionality analyses and female/male ratio analyses. During January 2004 to March 2023, 101,746 fall-related AEs were reported in FAERS from patients aged 50 to 100, with 68,492 (67.3%) females and 32,547 (32.0%) males. We found 261 signals for females while 284 for males. For females, the top 3 signals with the highest reporting odds ratio (ROR) were anethole trithione, clopenthixol, nikethamide (ROR: 388.88, 212.10, 113.94), while the top 3 signals with the highest lower limit of information component (IC025) were nikethamide, anethole trithione, benzbromarone (IC025: 3.91, 3.15, 2.49). For males, the top 3 signals with the highest ROR were fluprednidene acetate, potassium hydroxide, ketazolam (ROR: 216.86, 108.43, 108.43), while the top 3 signals with the highest IC025 were clomethiazole, piribedil, melperone (IC025: 3.31, 3.24, 2.99). Moreover, among the 119 shared signals found between males and females, 33 were positively correlated with falls in females and 38 with falls in males. Signals showing significant sex differences were mainly concentrated on agents of the immune, nervous, musculo-skeletal, and cardiovascular systems. We offered a series of FRIDs and suggested their sex differences in falls through the FAERS. In the future, it is essential to balance the inclusion of women and men, and analyse sex-stratified for FRIDs.https://doi.org/10.1038/s41598-024-81342-wFall-risk-increasing drugsSex differencesPharmacovigilanceMiddle-aged and elderlyReporting odds ratioBayesian confidence propagation neural network
spellingShingle Ying Zhao
Yuke Zhong
Liuqing Wu
Jiao Yan
Weitao Lu
Sex differences of fall-risk-increasing drugs in the middle-aged and elderly: a descriptive, cross-sectional study of FDA adverse event reporting system
Scientific Reports
Fall-risk-increasing drugs
Sex differences
Pharmacovigilance
Middle-aged and elderly
Reporting odds ratio
Bayesian confidence propagation neural network
title Sex differences of fall-risk-increasing drugs in the middle-aged and elderly: a descriptive, cross-sectional study of FDA adverse event reporting system
title_full Sex differences of fall-risk-increasing drugs in the middle-aged and elderly: a descriptive, cross-sectional study of FDA adverse event reporting system
title_fullStr Sex differences of fall-risk-increasing drugs in the middle-aged and elderly: a descriptive, cross-sectional study of FDA adverse event reporting system
title_full_unstemmed Sex differences of fall-risk-increasing drugs in the middle-aged and elderly: a descriptive, cross-sectional study of FDA adverse event reporting system
title_short Sex differences of fall-risk-increasing drugs in the middle-aged and elderly: a descriptive, cross-sectional study of FDA adverse event reporting system
title_sort sex differences of fall risk increasing drugs in the middle aged and elderly a descriptive cross sectional study of fda adverse event reporting system
topic Fall-risk-increasing drugs
Sex differences
Pharmacovigilance
Middle-aged and elderly
Reporting odds ratio
Bayesian confidence propagation neural network
url https://doi.org/10.1038/s41598-024-81342-w
work_keys_str_mv AT yingzhao sexdifferencesoffallriskincreasingdrugsinthemiddleagedandelderlyadescriptivecrosssectionalstudyoffdaadverseeventreportingsystem
AT yukezhong sexdifferencesoffallriskincreasingdrugsinthemiddleagedandelderlyadescriptivecrosssectionalstudyoffdaadverseeventreportingsystem
AT liuqingwu sexdifferencesoffallriskincreasingdrugsinthemiddleagedandelderlyadescriptivecrosssectionalstudyoffdaadverseeventreportingsystem
AT jiaoyan sexdifferencesoffallriskincreasingdrugsinthemiddleagedandelderlyadescriptivecrosssectionalstudyoffdaadverseeventreportingsystem
AT weitaolu sexdifferencesoffallriskincreasingdrugsinthemiddleagedandelderlyadescriptivecrosssectionalstudyoffdaadverseeventreportingsystem