Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting system DOI Creative Commons
Yunhan Zhao,

Haoxiang Hu,

Jiesheng Mao

et al.

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

Published: May 14, 2025

Background Baclofen, a centrally acting muscle relaxant, is widely utilized for the management of spasms and alcohol use disorders associated with conditions. However, its neurological safety tolerability in large population remain limited. This study aimed to assess potential risks baclofen real world. Methods Data covering period from first quarter 2004 third 2024 were collected Food Drug Administration Adverse Event Reporting System (FAERS). Four disproportionality analysis methods employed: Odds Ratio, Proportional Bayesian Confidence Propagation Neural Network, Multi-item Gamma Poisson Shrinkage (MGPS). These used detect evaluate adverse events drug baclofen. Additionally, time onset was conducted. Results A total 432 neurological-related preferred terms (PTs) identified. The number PT that positive all four algorithms 40, top 5 Hypotonia, Encephalopathy, Coma, Unresponsive stimuli, Cerebrospinal fluid leakage. PTs ROR values are Intracranial hypotension [ROR 66.24 (55.45–79.13)], leakage 51.34 (45.84–57.51)], Autonomic dysreflexia 47.4 (32.27–69.63)], Basal ganglion degeneration 33.03 (18.54–58.84)], Sciatic nerve palsy 21.6 (11.14–41.87)]. median -related ADEs 27 days. Most cases (n = 241, 55.5%) occurred within month administration. In an severe vs. non-severe ADEs, found incidence higher than cases, no gender-related differences observed. Conclusion identified clinically significant using different performed gender subgroup analysis. TTO indicated most Furthermore, frequency ones. Clinicians should closely monitor effects caused by baclofen, particularly consider individualized dosing strategies. Further research based on real-world data needed validate these findings.

Language: Английский

Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting system DOI Creative Commons
Yunhan Zhao,

Haoxiang Hu,

Jiesheng Mao

et al.

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

Published: May 14, 2025

Background Baclofen, a centrally acting muscle relaxant, is widely utilized for the management of spasms and alcohol use disorders associated with conditions. However, its neurological safety tolerability in large population remain limited. This study aimed to assess potential risks baclofen real world. Methods Data covering period from first quarter 2004 third 2024 were collected Food Drug Administration Adverse Event Reporting System (FAERS). Four disproportionality analysis methods employed: Odds Ratio, Proportional Bayesian Confidence Propagation Neural Network, Multi-item Gamma Poisson Shrinkage (MGPS). These used detect evaluate adverse events drug baclofen. Additionally, time onset was conducted. Results A total 432 neurological-related preferred terms (PTs) identified. The number PT that positive all four algorithms 40, top 5 Hypotonia, Encephalopathy, Coma, Unresponsive stimuli, Cerebrospinal fluid leakage. PTs ROR values are Intracranial hypotension [ROR 66.24 (55.45–79.13)], leakage 51.34 (45.84–57.51)], Autonomic dysreflexia 47.4 (32.27–69.63)], Basal ganglion degeneration 33.03 (18.54–58.84)], Sciatic nerve palsy 21.6 (11.14–41.87)]. median -related ADEs 27 days. Most cases (n = 241, 55.5%) occurred within month administration. In an severe vs. non-severe ADEs, found incidence higher than cases, no gender-related differences observed. Conclusion identified clinically significant using different performed gender subgroup analysis. TTO indicated most Furthermore, frequency ones. Clinicians should closely monitor effects caused by baclofen, particularly consider individualized dosing strategies. Further research based on real-world data needed validate these findings.

Language: Английский

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