| アブストラクト | BACKGROUND: Tafamidis emerged as the first FDA-approved drug for treating termed amyloid fibrils. This study aims to analyze adverse events (AEs) related to tafamidis from the second quarter (Q2) of 2019 to the fourth quarter (Q4) of 2023 from the FDA adverse event reporting system (FAERS) database. RESEARCH DESIGN AND METHODS: The AE data related to tafamidis from 2019 Q2 to 2023 Q4 were collected and standardized. Various signal quantification techniques, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker, were employed for analysis. RESULTS: Among the 8742 AE reports with tafamidis as the primary suspected drug, 180 preferred terms of AEs spanning 27 different system organ classes were identified. Unique adverse events to tafamidis included renal and urinary disorders and ear and labyrinth disorders, with not mentioned in the official drug label. Additionally, uncommon but significantly strong AE signals, such as blood culture positive and acquired hemophilia, were observed. Common AEs with relatively high occurrence rates included death, off-label use, fall, hypoacusis, and dysphagia. CONCLUSION: These findings offer valuable insights for optimizing the use of tafamidis and reducing potential side effects, thereby facilitating its safe use in clinical settings. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2024/12/5 |
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| 投稿者 | Chen, Min; Huang, Yaping; Ke, Chengjie; Chen, Maohua |
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| 組織名 | Department of Orthopedics, Fujian Medical University Union Hospital, Fuzhou,;China.;Department of Pharmacy, Shengli Clinical Medical College of Fujian Medical;University, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial;Hospital, Fuzhou, China.;Department of Pharmacy, The First Affiliated Hospital of Fujian Medical;University, Fuzhou, China.;Department of Pharmacy, National Regional Medical Center, Binhai Campus of the;First Affiliated Hospital, Fujian Medical University, Fuzhou, China.;Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Fuzhou, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39636580/ |
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