| アブストラクト | OBJECTIVE: Muscle toxicity can significantly impair quality of life and may be life-threatening in severe cases. Although statins are well known for their risk of muscle toxicity, a comprehensive evaluation of other implicated drugs remains limited. This study aimed to systematically characterize drug-related muscle toxicity using adverse event (AE) reports from the U.S. Food and Drug Adverse Event Reporting System (FAERS). METHODS: FAERS data from the first quarter of 2004 to the fourth quarter of 2024 were extracted and processed. Signal detection was conducted using three disproportionality analysis methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN). Sensitivity analyses were conducted through stratification by sex, age, and reporter type. External validation was performed using the WHO VigiAccess database. RESULTS: A total of 49,289 reports related to muscle toxicity were identified, involving 47,241 cases and 220 drugs. The mean time to onset was 324.75 days, with a median of 30.00 days. Nervous system drugs accounted for the largest proportion (27.3%), followed by anti-infective agents (22.3%), and cardiovascular drugs (19.5%). The most frequently reported drugs included atorvastatin (n = 5,275), simvastatin (n = 4,831), rosuvastatin (n = 3,209), levetiracetam (n = 1,021), and quetiapine (n = 725). Several drugs not prominently described for muscle toxicity in product labeling showed disproportionality signals, including furosemide [n = 239; ROR (95%CI):3.35 (2.95-3.81)], and diazepam [n = 141; ROR (95%CI): 2.78 (2.36-3.28)]. Rhabdomyolysis was the most frequently reported and clinically significant AE. Additional signals were observed for drugs with limited or unclear labeling regarding rhabdomyolysis, including oseltamivir [n = 63; ROR (95%CI): 2.51 (1.96-3.22)], metformin [n = 397; ROR (95%CI): 2.52 (2.28-2.78)], and alprazolam [n = 178; ROR (95%CI): 2.60 (2.24-3.01)]. Sensitivity analyses and external validation showed generally consistent patterns across subgroups and databases. CONCLUSION: This study provides a comprehensive pharmacovigilance evaluation of muscle toxicity-related reports and corresponding drugs using FAERS data. Several drugs with signals not prominently described in current product labeling were identified. These findings highlight the importance of continued pharmacovigilance and may support signal detection and hypothesis generation for future research. |
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| ジャーナル名 | Frontiers in pharmacology |
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| Pubmed追加日 | 2026/7/13 |
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| 投稿者 | Zhang, Lei; Wang, Yuqi; Wang, Fang; Ji, Kaiyun; Yang, Lili; Li, Jia |
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| 組織名 | Department of Pharmacy, The First Affiliated Hospital of Sun Yat-sen University,;Guangzhou, China.;Department of Pharmacy, Shanxi Provincial Integrated TCM and WM Hospital,;Taiyuan, China.;Department of Pharmacy, Guizhou Hospital of The First Affiliated Hospital of Sun;Yat-sen University (The Affiliated Hospital of Guizhou Medical University),;Guiyang, China.;Department of Pharmacy, Jincheng General Hospital, Jincheng, China.;Department of Pharmacy, Guangxi Hospital Division of the First Affiliated;Hospital, Sun Yat-sen University, Nanning, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42440952/ |
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