| アブストラクト | INTRODUCTION: Levetiracetam is a relatively new and widely utilized anti-seizure medication; however, limited information is available regarding its adverse effects. This study aims to thoroughly investigate, evaluate, and present evidence on the safety profile of Levetiracetam, relying on data from the FDA Adverse Event Reporting System (FAERS) database to facilitate informed clinical decision-making. METHODS: We employed various statistical measures, including Reporting Odds Ratio (ROR), Proportionate Reporting Ratio (PRR), and analysis by the Medicines and Healthcare Products Regulatory Agency (MHRA), to identify signals of adverse reactions associated with Levetiracetam. Positive signals consistent with Designated Medical Event (DME) were singled out for focused comparison and discussion. RESULTS: The analysis of 26,182 adverse events linked to Levetiracetam as the primary suspected drug revealed 692 positive signals spanning 22 System Organ Classes (SOCs). Nervous system disorders were the most frequently reported, followed by psychiatric disorders, and general disorders and administration site conditions. 11 positive signals consistent with Preferred Terms (PTs) in DME were identified, predominantly concentrated in 6 SOCs. Among these, rhabdomyolysis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) exhibited relatively large values of A, ROR, and Chi-squared. Additionally, PTs related to spontaneous abortion, drug interaction, urethral atresia, ventricular septal defect, and atrial septal defect showed significant strength. CONCLUSIONS: The study indicates that Levetiracetam carries a potential risk of causing rhabdomyolysis, SJS, TEN, DRESS as well as spontaneous abortion. Signals related to drug interaction, urethral atresia, ventricular septal defect, and atrial septal defect warrant heightened attention in clinical use. |
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| ジャーナル名 | Seizure |
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| 投稿日 | 2024/3/28 |
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| 投稿者 | He, Zhimin; Liu, Cuimin; Lin, Lin; Feng, Guowen; Wu, Gang |
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| 組織名 | School of Pharmacy, Wenzhou Medical University, Wenzhou, 325035, PR China.;Department of Pharmacy, Taizhou Hospital of Zhejiang Province affiliated to;Wenzhou Medical University, Linhai, Zhejiang, 317000, PR China.;Wenzhou Medical University, Linhai, Zhejiang, 317000, PR China; School of;Pharmacy, Wenzhou Medical University, Wenzhou, 325035, PR China.;Department of Pharmacy, Langzhong People's Hospital, Nanchong, Sichuan, 637400,;PR China. Electronic address: 95326682@qq.com.;Wenzhou Medical University, Linhai, Zhejiang, 317000, PR China. Electronic;address: wug5937@enzemed.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38537425/ |
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