| アブストラクト | BACKGROUND: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare and life-threatening skin adverse reactions that are usually induced by drugs. This study aimed to assess the association between methotrexate and SJS/TEN when combined with furosemide. RESEARCH DESIGN AND METHODS: Data on suspicious, interactions (PS, SS, I) from the FDA Adverse Event Reporting System database for 2016-2021 were analyzed using the reporting odds ratio (ROR), information component (IC), proportional reporting ratio (PRR) and the Medications and Health Care Products Regulatory Agency (MHRA). RESULTS: We identified 28 case reports of TEN associated with the combination of furosemide and methotrexate and 10 reports of SJS associated with furosemide and methotrexate. The association of methotrexate with SJS/TEN was more significant in the entire data set when combined with furosemide than when methotrexate was not combined with furosemide. The association of methotrexate with SJS/TEN remained significant when furosemide was combined with methotrexate in a tumor-based disease context. After sensitivity analysis of the entire dataset as well as all antineoplastic drug datasets, consistent results were observed for TEN. CONCLUSIONS: Our study confirmed a significant association between methotrexate and SJS/TEN when combined with furosemide, with an increased risk of SJS/TEN. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2023/4/19 |
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| 投稿者 | Zhuo, Shengnan; Dong, Tu; Yue, Zhongsheng; Qian, Yating; Liu, Xinling; Liu, Wei |
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| 組織名 | School of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37070136/ |
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