アブストラクト | INTRODUCTION: Nusinersen, the initial FDA-approved medication, treats Spinal Muscular Atrophy. This study utilized the FDA's adverse event reporting system (FAERS) database to examine, evaluate, and provide substantiation for the safety of Nusinersen to assist in clinical decision-making. METHODS: Nusinersen-related adverse reaction signals were mined using the reporting odds ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN), Multi-item Gamma-Poisson Shrinker (MGPS) models with Empirical Bayesian Geometric Mean (EBGM). The rate and frequency of reported adverse reactions were investigated. RESULTS: Nusinersen-induced adverse events were observed in 25 system organ categories (SOCs). A total of 230 disproportionate preferred terms (PTs) were eliminated using four algorithms. Cardiac arrest, autism spectrum disorder, and epilepsy emerged as potential new side effects not previously listed, warranting further attention for drug safety. Analysis of the age distribution of the signals found that younger patients should be watched out for upper respiratory tract infections and increased CSF pressure; senior patients should be extensively checked for symptoms of post-lumbar puncture syndrome and protein urine present. CONCLUSIONS: Our investigation discovered potential signals of novel adverse drug events that could support clinical monitoring and risk identification of Nusinersen. However, these results should be interpreted with caution. |
ジャーナル名 | Expert opinion on drug safety |
Pubmed追加日 | 2024/12/18 |
投稿者 | Zhang, Xiaofang; Gui, Jianxiong; Wang, Lingman; Jiang, Chunxue; Ding, Ran; Meng, Linxue; Hong, Siqi; Jiang, Li |
組織名 | Department of Neurology, Children's Hospital of Chongqing Medical University,;National Clinical Research Center for Child Health and Disorders, Ministry of;Education Key Laboratory of Child Development and Disorders, Chongqing Key;Laboratory of Child Neurodevelopment and Cognitive Disorders, Chongqing, China. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39690144/ |