| アブストラクト | OBJECTIVE: Based on the FDA Adverse Event Reporting System (FAERS), drugs associated with an increased risk of severe anaphylaxis (SA) in children and adolescents were identified to provide a basis for safe drug use. METHODS: Adverse drug event (ADE) reports from the first quarter of 2004 to the fourth quarter of 2023 were retrieved from FAERS. The Reporting Odds Ratio (ROR), Proportional ADR Reporting Ratio (PRR), Medicines and Healthcare Products Regulatory Agency (MHRA) Combined Criteria Method, Bayesian Confidence Propagation Neural Network (BCPNN), and Multiple Empirical Bayes Gamma-Poisson Shrinker (MGPS) methods were used in this study for mining drug signals. RESULTS: In total, 138 valid positive drug signals were obtained. Anti-infective drugs accounted for the highest cumulative number of ADE reports (845 cases). Of the top 30 drugs, ibuprofen accounted for 369 cases, and ceftriaxone was associated with the highest number of deaths. The drug instructions of human normal immunoglobulin (HNIg) and sevoflurane did not mention ADEs associated with SA. The prognosis for SA was poorer in younger children. CONCLUSION: Monitoring of SA induced by antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs) should be continued in pediatric patients. The possibility of adverse reactions with HNIg and sevoflurane should be highlighted. IMPACT: This study used data from the FAERS database to explore drugs associated with severe anaphylaxis (SA) in children and studied the prognosis of these reactions in children across different age groups as a reference for safer medication use in children. Among the positive drugs, the top three drugs with the highest number of adverse events were ibuprofen, infliximab, and omalizumab. In addition, there are two drugs (human normal immunoglobulin and sevoflurane) whose related adverse drug reactions for SA are not mentioned in the instructions. |
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| ジャーナル名 | Pediatric research |
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| Pubmed追加日 | 2026/11/3 |
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| 投稿者 | Wang, Xinru; Wu, Jianru; Wu, Jingying; Tang, Biyu; Li, Hongqiao; Wei, Fenfang; Zhang, Yi; Li, Limin; Huang, Lingling; Wang, Bei; Wu, Wenyu; Hong, Xiang |
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| 組織名 | Key Laboratory of Environmental Medicine and Engineering of Ministry of;Education, Department of Epidemiology and Health Statistics, School of Public;Health, Southeast University, Nanjing, China.;Shenzhen Institute of Pharmacovigilance and Risk Management, Guangdong, China.;wuwenyu000@163.com.;Health, Southeast University, Nanjing, China. hongxiang@seu.edu.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42972036/ |
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