| アブストラクト | BACKGROUND: The safety reports arising currently on nimesulide are divulging the jeopardy of skin and subcutaneous tissue disorders (SSTDs). RESEARCH DESIGN AND METHODS: The global individual case safety reports on nimesulide-induced SSTDs available at VigiBase(R) were analyzed up to 31 March 2023. Disproportionality analyses viz. Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and Information Component (IC) were performed to identify the quantitative signals. RESULTS: Out of 33,983,649 de-duplicated cases available in the VigiBase((R)), 1,664,134 (4.9%) were in pediatrics below 12 years of age. Among these, cases attributed to nimesulide were 251, of which 126 (50.2%) were on SSTDs. Among all the SSTDs reported for nimesulide, the serious reactions like urticaria [PRR = 2.3; lower bound (LB) ROR = 1.7; IC(025) = 0.6], Stevens-Johnson syndrome (SJS) [PRR = 28.3; LB ROR = 18.2; IC(025) = 3.2], angioedema [PRR = 7.5; LB ROR = 4.5; IC(025) = 1.7], and toxic epidermal necrolysis (TEN) [PRR = 27.4; LB ROR = 11.5; IC(025) = 1.5] were identified as potential signals. In comparison with non-SSTDs, SSTDs reported for nimesulide were significantly higher among children (2-11 years, 90.5%), from India (38.9%), and by the physician (60.3%). CONCLUSIONS: Identifying the giant quantitate association between nimesulide and serious & life-threatening reactions like SJS and TEN, precautionary measures need to be taken by the regulatory authorities to prevent nimesulide-induced SSTDs among the pediatric population. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2023/11/1 |
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| 投稿者 | Undela, Krishna; Kalaiselvan, Vivekanandan; Gudi, Sai Krishna; Viswam, Subeesh K; Ali, Syed Kashif |
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| 組織名 | Department of Pharmacy Practice, National Institute of Pharmaceutical Education;and Research (NIPER) Guwahati, Kamrup, Assam, India.;Pharmacovigilance Programme of India (PvPI), National Coordination Centre, Indian;Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, India.;College of Pharmacy, Rady Faculty of Health Sciences, University of Manitoba,;Winnipeg, Canada.;Independent Researcher, and formerly Department of Pharmacy Practice, Manipal;College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal,;Karnataka, India. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37908194/ |
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