| アブストラクト | BACKGROUND: Drug-induced enterocolitis syndrome (DIES) is a rare, non-IgE-mediated allergic reaction occurring 1 to 4 hours after drug ingestion. OBJECTIVE: The purpose of this evaluation was to describe postmarketing reports of DIES in patients receiving amoxicillin-containing products. METHODS: We queried the US Food and Drug Administration Adverse Event Reporting System database and the medical literature (Embase, PubMed) for cases of DIES in patients receiving amoxicillin-containing products through September 26, 2024. Cases were included if DIES was diagnosed via a positive result of a graded challenge with vomiting occurring 1 to 4 hours after ingestion, absence of classic IgE-mediated symptoms, and at least 3 minor criteria having been met. Causality was assessed using the World Health Organization Uppsala Monitoring Centre system for standardized case causality assessment. RESULTS: After the application of inclusion and causality criteria, 12 cases were identified (median case patient age 6 years). Most of the case patients required medical intervention, including intravenous fluids (10 of 12), emergency department visits or hospitalization (9 of 12), and supportive treatments. Of the 12 case patients, 6 were reported as having leukocytosis with neutrophilia. All cases resolved within 24 hours after drug administration and supportive care. CONCLUSION: This case series summarizes reports of DIES associated with amoxicillin-containing product use and highlights the management, pathogenesis, and recent changes to the US prescribing information. |
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| ジャーナル名 | The journal of allergy and clinical immunology. Global |
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| Pubmed追加日 | 2025/11/11 |
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| 投稿者 | Beganovic, Maya; Kapoor, Rachna; Jones, S Christopher; Lee, Jenni Yoon |
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| 組織名 | Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center;for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring,;Md. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41216415/ |
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