Comprehensive analysis of adverse events associated with vortioxetine using the FDA adverse event reporting system DOI Creative Commons

Liangxia Li,

Qianqian Xu,

Liangfang Pang

et al.

Frontiers in Pharmacology, Journal Year: 2025, Volume and Issue: 16

Published: May 2, 2025

Background Vortioxetine is a novel antidepressant belonging to the class of selective serotonin reuptake inhibitors. This study aims comprehensively analyze adverse events (AEs) associated with vortioxetine by analyzing FDA Adverse Event Reporting System (FAERS) database. Methods collected reports as primary suspected drug in FAERS database from fourth quarter 2013 2023. We conducted disproportionality analysis quantify signals AEs using Odds Ratio (ROR), Proportional (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma-Poisson Shrinker (MGPS). Results A total 12,279 30,104 were identified. 51.57% AE originated consumers 45.85% health professional. The involved 27 different system organs (SOCs). 158 identified, including some common such nausea, vomiting, unexpected vision blurred, bruxism, disturbance attention, akathisia, restless legs syndrome, urinary retention, electrocardiogram QT prolonged. Gender-specific showed high-risk for females (nausea, crying, contusion, weight increased, pruritus) males (completed suicide, negative thoughts, anorgasmia, libido decreased, sexual dysfunction). median onset time was 7 days (interquartile range [IQR] 0–30 days), most (75.10%) occurred within first month after initiation vortioxetine. Conclusion Our identified potential new signals, offering broader understanding safety profile vortioxetine, providing valuable references its clinical monitoring further research. It should be noted that nearly half patients, highlighting value patient-reported data pharmacovigilance, but also reminding us need cautious interpretation due self-reporting biases.

Language: Английский

Comprehensive pharmacovigilance analysis of belumosudil: A real-world study using the FDA adverse event reporting system (FAERS) DOI Creative Commons
Hua Yang, X. Huang, Jin Wu

et al.

Research Square (Research Square), Journal Year: 2025, Volume and Issue: unknown

Published: March 27, 2025

Abstract Belumosudil is a first-in-class ROCK2 inhibitor approved by the US Food and Drug Administration (FDA) in 2021 for treatment of chronic graft-versus-host disease (cGVHD). With its growing clinical use, comprehensive understanding real-world safety profile essential. In this study, we assessed adverse events (AEs) associated with belumosudil analyzing data from publicly available Adverse Event Reporting System (FAERS) database, offering valuable insights safety. The AEs report were collected FAERS database covering period third quarter to fourth 2024. association between was investigated utilizing four algorithms: reporting odds ratio (ROR), proportional (PRR), Bayesian confidence propagation neural network (BCPNN), multi-item gamma Poisson shrinker (MGPS). Additionally, Weibull distribution used model risk over time. A total 1964 cases identified, comprising 5765 AE reports. reactions documented on drug label, such as fatigue, nausea, infection, pneumonia, rash. potential not mentioned label also including inappropriate schedule product administration, use unapproved indication, stomatitis, dry eye, cataract, depressed mood, emotional disorder, neuropathy peripheral. median onset time belumosudil‑associated 66 days (interquartile range [IQR] 23–155 days), majority occurred within first 30 after initiation. conclusion, preliminarily explores belumosudil, identifying both known new signals. These findings provide support monitoring identification belumosudil.

Language: Английский

Citations

0
Comprehensive analysis of adverse events associated with vortioxetine using the FDA adverse event reporting system DOI Creative Commons

Liangxia Li,

Qianqian Xu,

Liangfang Pang

et al.

Frontiers in Pharmacology, Journal Year: 2025, Volume and Issue: 16

Published: May 2, 2025

Background Vortioxetine is a novel antidepressant belonging to the class of selective serotonin reuptake inhibitors. This study aims comprehensively analyze adverse events (AEs) associated with vortioxetine by analyzing FDA Adverse Event Reporting System (FAERS) database. Methods collected reports as primary suspected drug in FAERS database from fourth quarter 2013 2023. We conducted disproportionality analysis quantify signals AEs using Odds Ratio (ROR), Proportional (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma-Poisson Shrinker (MGPS). Results A total 12,279 30,104 were identified. 51.57% AE originated consumers 45.85% health professional. The involved 27 different system organs (SOCs). 158 identified, including some common such nausea, vomiting, unexpected vision blurred, bruxism, disturbance attention, akathisia, restless legs syndrome, urinary retention, electrocardiogram QT prolonged. Gender-specific showed high-risk for females (nausea, crying, contusion, weight increased, pruritus) males (completed suicide, negative thoughts, anorgasmia, libido decreased, sexual dysfunction). median onset time was 7 days (interquartile range [IQR] 0–30 days), most (75.10%) occurred within first month after initiation vortioxetine. Conclusion Our identified potential new signals, offering broader understanding safety profile vortioxetine, providing valuable references its clinical monitoring further research. It should be noted that nearly half patients, highlighting value patient-reported data pharmacovigilance, but also reminding us need cautious interpretation due self-reporting biases.

Language: Английский

Citations

0