Signal detection and analysis of sulfasalazine adverse reaction events based on the US FDA adverse event reporting database.

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Signal detection and analysis of sulfasalazine adverse reaction events based on the US FDA adverse event reporting database.

Signal detection and analysis of sulfasalazine adverse reaction events based on the US FDA adverse event reporting database.

ジャーナル名	Expert opinion on drug safety
Pubmed追加日	2024/12/6
投稿者	Du, Yikuan; Zhang, Lingzhi; Shi, Liang; Guo, Zhuoming; Luo, Ziyi; Zheng, Ye; Zeng, Yu; Huang, Yin; Luo, Jiawen; Guo, Xiaochun; Hu, Mianda; Chen, Yuhong; Zhu, Jinfeng; Liu, Yi; Yang, Chun
組織名	Central Laboratory, The Tenth Affiliated Hospital of Southern Medical University,;Dongguan, China.;Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The;First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong;Medical University, Dongguan, China.;The First Dongguan Affliation Hospital of Guangdong Medical University, Dongguan,;China.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/39639677/
アブストラクト	BACKGROUND: Based on real data from the FDA Adverse Event Reporting System (FAERS), we explored and evaluated the adverse reactions (ADRs) of sulfasalazine (SSZ) in the first quarter of 2004-2023 to provide a reference basis and early warning for the safe use of SSZ in the clinic. RESEARCH DESIGN AND METHODS: The reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the empirical Bayesian geometric mean (EBGM) were used as measures of SSZ-associated adverse events (AEs) signals, mining for potential positive signals between SSZ and AE. RESULTS: In this study, a total of 5327 case reports related to SSZ in the last 20 years involving 25 system organ classes (SOCs) were collected in FAERS. The AEs of SSZ were mainly focused on Immune system disorders (n = 1621, IC025 = 2.86), Blood and lymphatic system disorders (n = 638, IC025 = 2.4), and others. In addition, we found 41 adverse reactions not mentioned in the specification, including oculomucocutaneous syndrome (n = 12, IC025 = 4.86), wegener's granulomatosis(n = 6, IC025 = 4.05) and reproductive system aspects. CONCLUSION: Significant new AEs signals were observed in this study and may provide important support for clinical monitoring and risk identification in SSZ.