Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting system
BackgroundBaclofen, a centrally acting muscle relaxant, is widely utilized for the management of muscle spasms and alcohol use disorders associated with conditions. However, its neurological safety and tolerability in a large population remain limited. This study aimed to assess the neurological saf...
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Frontiers Media S.A.
2025-05-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2025.1569602/full |
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| author | Yunhan Zhao Haoxiang Hu Jiesheng Mao Jianghai He Yihan Zhang Xiaokai Yang |
| author_facet | Yunhan Zhao Haoxiang Hu Jiesheng Mao Jianghai He Yihan Zhang Xiaokai Yang |
| author_sort | Yunhan Zhao |
| collection | DOAJ |
| description | BackgroundBaclofen, a centrally acting muscle relaxant, is widely utilized for the management of muscle spasms and alcohol use disorders associated with conditions. However, its neurological safety and tolerability in a large population remain limited. This study aimed to assess the neurological safety and potential risks of baclofen in the real world.MethodsData covering the period from the first quarter of 2004 to the third quarter of 2024 were collected from the Food and Drug Administration Adverse Event Reporting System (FAERS). Four disproportionality analysis methods were employed: the Reporting Odds Ratio, the Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and the Multi-item Gamma Poisson Shrinkage (MGPS). These methods were used to detect and evaluate adverse events Adverse drug events associated with baclofen. Additionally, the time to onset analysis was conducted.ResultsA total of 432 neurological-related preferred terms (PTs) were identified. The number of PT that were positive for all four algorithms was 40, and the top 5 PT were Hypotonia, Encephalopathy, Coma, Unresponsive to stimuli, and Cerebrospinal fluid leakage. The top 5 PTs for ROR values are Intracranial hypotension [ROR 66.24 (55.45–79.13)], Cerebrospinal fluid leakage [ROR 51.34 (45.84–57.51)], Autonomic dysreflexia [ROR 47.4 (32.27–69.63)], Basal ganglion degeneration [ROR 33.03 (18.54–58.84)], Sciatic nerve palsy [ROR 21.6 (11.14–41.87)]. The median onset time for baclofen -related ADEs was 27 days. Most cases (n = 241, 55.5%) occurred within the first month of baclofen administration. In an analysis of severe vs. non-severe ADEs, the study found that the incidence of severe cases was higher than that of non-severe cases, with no gender-related differences observed.ConclusionThis study identified clinically significant PTs using four different algorithms and performed gender subgroup analysis. The TTO analysis indicated that the onset of most ADEs occurred within 27 days. Furthermore, the frequency of severe ADEs was higher than that of non-severe ones. Clinicians should closely monitor for neurological adverse effects caused by baclofen, particularly severe ADEs, and consider individualized dosing strategies. Further research based on real-world data is needed to validate these findings. |
| format | Article |
| id | doaj-art-660ddbb24efd4a7592eb09def085a176 |
| institution | Kabale University |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pharmacology |
| spelling | doaj-art-660ddbb24efd4a7592eb09def085a1762025-08-20T03:49:42ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-05-011610.3389/fphar.2025.15696021569602Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting systemYunhan ZhaoHaoxiang HuJiesheng MaoJianghai HeYihan ZhangXiaokai YangBackgroundBaclofen, a centrally acting muscle relaxant, is widely utilized for the management of muscle spasms and alcohol use disorders associated with conditions. However, its neurological safety and tolerability in a large population remain limited. This study aimed to assess the neurological safety and potential risks of baclofen in the real world.MethodsData covering the period from the first quarter of 2004 to the third quarter of 2024 were collected from the Food and Drug Administration Adverse Event Reporting System (FAERS). Four disproportionality analysis methods were employed: the Reporting Odds Ratio, the Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and the Multi-item Gamma Poisson Shrinkage (MGPS). These methods were used to detect and evaluate adverse events Adverse drug events associated with baclofen. Additionally, the time to onset analysis was conducted.ResultsA total of 432 neurological-related preferred terms (PTs) were identified. The number of PT that were positive for all four algorithms was 40, and the top 5 PT were Hypotonia, Encephalopathy, Coma, Unresponsive to stimuli, and Cerebrospinal fluid leakage. The top 5 PTs for ROR values are Intracranial hypotension [ROR 66.24 (55.45–79.13)], Cerebrospinal fluid leakage [ROR 51.34 (45.84–57.51)], Autonomic dysreflexia [ROR 47.4 (32.27–69.63)], Basal ganglion degeneration [ROR 33.03 (18.54–58.84)], Sciatic nerve palsy [ROR 21.6 (11.14–41.87)]. The median onset time for baclofen -related ADEs was 27 days. Most cases (n = 241, 55.5%) occurred within the first month of baclofen administration. In an analysis of severe vs. non-severe ADEs, the study found that the incidence of severe cases was higher than that of non-severe cases, with no gender-related differences observed.ConclusionThis study identified clinically significant PTs using four different algorithms and performed gender subgroup analysis. The TTO analysis indicated that the onset of most ADEs occurred within 27 days. Furthermore, the frequency of severe ADEs was higher than that of non-severe ones. Clinicians should closely monitor for neurological adverse effects caused by baclofen, particularly severe ADEs, and consider individualized dosing strategies. Further research based on real-world data is needed to validate these findings.https://www.frontiersin.org/articles/10.3389/fphar.2025.1569602/fulladverse eventsdrug safetyFAERSbaclofendisproportionality analysispharmacovigilance |
| spellingShingle | Yunhan Zhao Haoxiang Hu Jiesheng Mao Jianghai He Yihan Zhang Xiaokai Yang Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting system Frontiers in Pharmacology adverse events drug safety FAERS baclofen disproportionality analysis pharmacovigilance |
| title | Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting system |
| title_full | Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting system |
| title_fullStr | Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting system |
| title_full_unstemmed | Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting system |
| title_short | Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting system |
| title_sort | neurological adverse events associated with baclofen a pharmacovigilance study based on fda adverse event reporting system |
| topic | adverse events drug safety FAERS baclofen disproportionality analysis pharmacovigilance |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1569602/full |
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