Overweight and glucose/lipid metabolism abnormality associated with SSRIs: a pharmacovigilance study based on the FDA adverse event reporting system

BackgroundIn the past few decades, selective serotonin reuptake inhibitors (SSRIs) became widely used antidepressants worldwide. Therefore, the adverse reactions of patients after SSRI administration became a public and clinical concern. In this study, we conducted a pharmacovigilance study using th...

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Main Authors: Jinming Cao, Zhicong Chen, Yan Wang, Yunpeng Ma, Zhen Yang, Jian Cai, Zhijun Xiao, Feng Xu
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Pharmacology
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Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2024.1517546/full
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author Jinming Cao
Zhicong Chen
Yan Wang
Yunpeng Ma
Zhen Yang
Jian Cai
Zhijun Xiao
Feng Xu
author_facet Jinming Cao
Zhicong Chen
Yan Wang
Yunpeng Ma
Zhen Yang
Jian Cai
Zhijun Xiao
Feng Xu
author_sort Jinming Cao
collection DOAJ
description BackgroundIn the past few decades, selective serotonin reuptake inhibitors (SSRIs) became widely used antidepressants worldwide. Therefore, the adverse reactions of patients after SSRI administration became a public and clinical concern. In this study, we conducted a pharmacovigilance study using the Adverse Event Reporting System (FAERS) database of the US Food and Drug Administration. Our main goal was to evaluate adverse events related to SSRIs, with a particular focus on abnormal weight gain and glucose/lipid metabolism disorders.MethodThe adverse event data for representative SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) was extracted from the FAERS database from 2004Q1 to 2023Q4. The reporting odds ratio and proportional reporting ratio were employed to explore relevant adverse event reports (ADEs) signals. Univariate logistic regression analysis was utilized to explore factors associated with glucose/lipid metabolism abnormality following SSRIs treatment.ResultsWe identified 143,744 ADE reports associated with SSRIs and revealed significant abnormal signals related to weight gain and glucose/lipid metabolism in depressed patients. Variations were observed among different SSRIs medications. Specifically, citalopram was associated with abnormal weight gain (ROR: 4, 95% CI: 3.1-5.2) and hepatic steatosis (ROR: 2.8, 95% CI: 2.1-3.6); escitalopram was correlated with gestational diabetes (ROR: 9.1, 95% CI: 6.6-12.4) and cholestasis (ROR: 2.4, 95% CI: 1.75-3.38); fluoxetine was associated with obesity (ROR: 2.8, 95% CI: 2.08-3.78); fluvoxamine was linked to arteriospasm coronary (ROR: 13.87, 95% CI: 4.47-43.1); and sertraline was implicated in neonatal jaundice (ROR: 16.1, 95% CI: 12.6-20.6). Females and younger age are important risk factors for the development of associated adverse effects.ConclusionOur study screened for adverse effects associated with abnormal glucose/lipid metabolism, such as abnormal body weight and fatty liver, in depressed patients taking selective serotonin reuptake inhibitors by utilizing FAERS database. This provides valuable insights for healthcare professionals in accepting and managing patients treated with SSRIs.
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spelling doaj-art-80b9b935e0ef49778456882bb11b033f2025-08-20T02:36:06ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-01-011510.3389/fphar.2024.15175461517546Overweight and glucose/lipid metabolism abnormality associated with SSRIs: a pharmacovigilance study based on the FDA adverse event reporting systemJinming Cao0Zhicong Chen1Yan Wang2Yunpeng Ma3Zhen Yang4Jian Cai5Zhijun Xiao6Feng Xu7Fengxian Hospital, Southern Medical University, Shanghai, ChinaFengxian Hospital, Southern Medical University, Shanghai, ChinaSixth People’s Hospital South Campus, Shanghai Jiaotong University, Shanghai, ChinaSixth People’s Hospital South Campus, Shanghai Jiaotong University, Shanghai, ChinaSixth People’s Hospital South Campus, Shanghai Jiaotong University, Shanghai, ChinaFengxian Mental Health Center, Shanghai, ChinaSixth People’s Hospital South Campus, Shanghai Jiaotong University, Shanghai, ChinaFengxian Hospital, Southern Medical University, Shanghai, ChinaBackgroundIn the past few decades, selective serotonin reuptake inhibitors (SSRIs) became widely used antidepressants worldwide. Therefore, the adverse reactions of patients after SSRI administration became a public and clinical concern. In this study, we conducted a pharmacovigilance study using the Adverse Event Reporting System (FAERS) database of the US Food and Drug Administration. Our main goal was to evaluate adverse events related to SSRIs, with a particular focus on abnormal weight gain and glucose/lipid metabolism disorders.MethodThe adverse event data for representative SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) was extracted from the FAERS database from 2004Q1 to 2023Q4. The reporting odds ratio and proportional reporting ratio were employed to explore relevant adverse event reports (ADEs) signals. Univariate logistic regression analysis was utilized to explore factors associated with glucose/lipid metabolism abnormality following SSRIs treatment.ResultsWe identified 143,744 ADE reports associated with SSRIs and revealed significant abnormal signals related to weight gain and glucose/lipid metabolism in depressed patients. Variations were observed among different SSRIs medications. Specifically, citalopram was associated with abnormal weight gain (ROR: 4, 95% CI: 3.1-5.2) and hepatic steatosis (ROR: 2.8, 95% CI: 2.1-3.6); escitalopram was correlated with gestational diabetes (ROR: 9.1, 95% CI: 6.6-12.4) and cholestasis (ROR: 2.4, 95% CI: 1.75-3.38); fluoxetine was associated with obesity (ROR: 2.8, 95% CI: 2.08-3.78); fluvoxamine was linked to arteriospasm coronary (ROR: 13.87, 95% CI: 4.47-43.1); and sertraline was implicated in neonatal jaundice (ROR: 16.1, 95% CI: 12.6-20.6). Females and younger age are important risk factors for the development of associated adverse effects.ConclusionOur study screened for adverse effects associated with abnormal glucose/lipid metabolism, such as abnormal body weight and fatty liver, in depressed patients taking selective serotonin reuptake inhibitors by utilizing FAERS database. This provides valuable insights for healthcare professionals in accepting and managing patients treated with SSRIs.https://www.frontiersin.org/articles/10.3389/fphar.2024.1517546/fullselective serotonin reuptake inhibitorsFAERSoverweightADEsglucose/lipid metabolism disorders
spellingShingle Jinming Cao
Zhicong Chen
Yan Wang
Yunpeng Ma
Zhen Yang
Jian Cai
Zhijun Xiao
Feng Xu
Overweight and glucose/lipid metabolism abnormality associated with SSRIs: a pharmacovigilance study based on the FDA adverse event reporting system
Frontiers in Pharmacology
selective serotonin reuptake inhibitors
FAERS
overweight
ADEs
glucose/lipid metabolism disorders
title Overweight and glucose/lipid metabolism abnormality associated with SSRIs: a pharmacovigilance study based on the FDA adverse event reporting system
title_full Overweight and glucose/lipid metabolism abnormality associated with SSRIs: a pharmacovigilance study based on the FDA adverse event reporting system
title_fullStr Overweight and glucose/lipid metabolism abnormality associated with SSRIs: a pharmacovigilance study based on the FDA adverse event reporting system
title_full_unstemmed Overweight and glucose/lipid metabolism abnormality associated with SSRIs: a pharmacovigilance study based on the FDA adverse event reporting system
title_short Overweight and glucose/lipid metabolism abnormality associated with SSRIs: a pharmacovigilance study based on the FDA adverse event reporting system
title_sort overweight and glucose lipid metabolism abnormality associated with ssris a pharmacovigilance study based on the fda adverse event reporting system
topic selective serotonin reuptake inhibitors
FAERS
overweight
ADEs
glucose/lipid metabolism disorders
url https://www.frontiersin.org/articles/10.3389/fphar.2024.1517546/full
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