Safety profiles of sevoflurane in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS database
ObjectiveThis study aimed to evaluate the safety profile of sevoflurane in pediatric populations using real-world data.MethodsData were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2024. We analyzed repo...
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Frontiers Media S.A.
2025-02-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2025.1548376/full |
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| author | Chuang Yang Bangjian Deng Qiang Wen Pei Guo Xiang Liu Chen Wang |
| author_facet | Chuang Yang Bangjian Deng Qiang Wen Pei Guo Xiang Liu Chen Wang |
| author_sort | Chuang Yang |
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| description | ObjectiveThis study aimed to evaluate the safety profile of sevoflurane in pediatric populations using real-world data.MethodsData were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2024. We analyzed reports where sevoflurane was the primary suspect in individuals aged 0–18, employing disproportionality analysis to detect adverse events associated with sevoflurane. We also compared the adverse events related to sevoflurane between pediatric and adult populations.ResultsThe FAERS database yielded 21,838,627 adverse event reports for children, with 474 involving sevoflurane as the primary suspect. Descriptive analysis revealed a majority of reports from male patients, primarily reported by physicians. Disproportionality analysis identified significant System Organ Classes (SOC) signals associated with sevoflurane, meeting four detection criteria, including “Cardiac disorders,” “Respiratory, thoracic, and mediastinal disorders,” and “Vascular disorders.” The study also identified previously unreported adverse events, such as “Encephalopathy” and “Hypercapnia.” Notable differences in signals were observed between children and adults for “Pulmonary alveolar hemorrhage,” “Anaphylactic shock,” and “Hypotension.”ConclusionOur analysis of the FAERS database identified several significant adverse events associated with sevoflurane in pediatrics, affecting the cardiovascular, respiratory, and nervous systems. Differences in adverse event signals between children and adults were also observed. Furthermore, the new adverse events (such as encephalopathy and hypercapnia) indicated that anesthesiologists should be more vigilant in administering sevoflurane. |
| format | Article |
| id | doaj-art-342e69576b0d482b80646952ec5d47af |
| institution | Kabale University |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pharmacology |
| spelling | doaj-art-342e69576b0d482b80646952ec5d47af2025-02-10T06:49:03ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-02-011610.3389/fphar.2025.15483761548376Safety profiles of sevoflurane in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS databaseChuang Yang0Bangjian Deng1Qiang Wen2Pei Guo3Xiang Liu4Chen Wang5Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatric Metabolism and Inflammatory Diseases, Department of Pharmacy, Children’s Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Chongqing, ChinaMinistry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatric Metabolism and Inflammatory Diseases, Department of Pharmacy, Children’s Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Chongqing, ChinaMinistry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatric Metabolism and Inflammatory Diseases, Department of Pharmacy, Children’s Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Chongqing, ChinaDepartment of Clinical Pharmacy, The First Affiliated Hospital of Chongqing Medical and pharmaceutical College, The Sixth People’s Hospital of Chongqing, Chongqing Prevention and Treatment Center for Occupational Diseases, Chongqing, ChinaDepartment of Clinical Pharmacy, The First Affiliated Hospital of Chongqing Medical and pharmaceutical College, The Sixth People’s Hospital of Chongqing, Chongqing Prevention and Treatment Center for Occupational Diseases, Chongqing, ChinaDepartment of Clinical Pharmacy, The First Affiliated Hospital of Chongqing Medical and pharmaceutical College, The Sixth People’s Hospital of Chongqing, Chongqing Prevention and Treatment Center for Occupational Diseases, Chongqing, ChinaObjectiveThis study aimed to evaluate the safety profile of sevoflurane in pediatric populations using real-world data.MethodsData were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2024. We analyzed reports where sevoflurane was the primary suspect in individuals aged 0–18, employing disproportionality analysis to detect adverse events associated with sevoflurane. We also compared the adverse events related to sevoflurane between pediatric and adult populations.ResultsThe FAERS database yielded 21,838,627 adverse event reports for children, with 474 involving sevoflurane as the primary suspect. Descriptive analysis revealed a majority of reports from male patients, primarily reported by physicians. Disproportionality analysis identified significant System Organ Classes (SOC) signals associated with sevoflurane, meeting four detection criteria, including “Cardiac disorders,” “Respiratory, thoracic, and mediastinal disorders,” and “Vascular disorders.” The study also identified previously unreported adverse events, such as “Encephalopathy” and “Hypercapnia.” Notable differences in signals were observed between children and adults for “Pulmonary alveolar hemorrhage,” “Anaphylactic shock,” and “Hypotension.”ConclusionOur analysis of the FAERS database identified several significant adverse events associated with sevoflurane in pediatrics, affecting the cardiovascular, respiratory, and nervous systems. Differences in adverse event signals between children and adults were also observed. Furthermore, the new adverse events (such as encephalopathy and hypercapnia) indicated that anesthesiologists should be more vigilant in administering sevoflurane.https://www.frontiersin.org/articles/10.3389/fphar.2025.1548376/fullFAERSadverse eventspediatricssevofluranepharmacovigilance |
| spellingShingle | Chuang Yang Bangjian Deng Qiang Wen Pei Guo Xiang Liu Chen Wang Safety profiles of sevoflurane in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS database Frontiers in Pharmacology FAERS adverse events pediatrics sevoflurane pharmacovigilance |
| title | Safety profiles of sevoflurane in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS database |
| title_full | Safety profiles of sevoflurane in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS database |
| title_fullStr | Safety profiles of sevoflurane in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS database |
| title_full_unstemmed | Safety profiles of sevoflurane in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS database |
| title_short | Safety profiles of sevoflurane in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS database |
| title_sort | safety profiles of sevoflurane in pediatric patients a real world pharmacovigilance assessment based on the faers database |
| topic | FAERS adverse events pediatrics sevoflurane pharmacovigilance |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1548376/full |
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