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.
Seizure. 2024 Apr;117:253-260. doi: 10.1016/j.seizure.2024.03.009. Epub 2024 Mar 21.
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.
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.
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.
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.
左乙拉西坦是一种相对较新且广泛应用的抗癫痫药物；然而，关于其不良反应的信息有限。本研究旨在通过利用 FDA 不良事件报告系统（FAERS）数据库中的数据，全面调查、评估并呈现左乙拉西坦的安全性概况，以帮助做出明智的临床决策。
我们使用了各种统计措施，包括报告比值比（ROR）、比例报告比值（PRR）和药品和保健品管理局（MHRA）分析，以识别与左乙拉西坦相关的不良反应信号。与指定医疗事件（DME）一致的阳性信号被挑出来进行重点比较和讨论。
对 26182 例与左乙拉西坦作为主要可疑药物相关的不良事件进行分析，发现 692 个阳性信号跨越 22 个系统器官类别（SOC）。神经系统疾病是最常报告的疾病，其次是精神科疾病和一般疾病以及给药部位状况。确定了 11 个与 DME 中的首选术语（PT）一致的阳性信号，主要集中在 6 个 SOC 中。其中，横纹肌溶解症、史蒂文斯-约翰逊综合征（SJS）、中毒性表皮坏死松解症（TEN）、药物反应伴嗜酸性粒细胞增多和全身症状（DRESS）表现出相对较大的 A、ROR 和卡方值。此外，与自然流产、药物相互作用、尿道闭锁、室间隔缺损和房间隔缺损相关的 PT 显示出显著的强度。
该研究表明，左乙拉西坦有引起横纹肌溶解症、SJS、TEN、DRESS 以及自然流产的潜在风险。与药物相互作用、尿道闭锁、室间隔缺损和房间隔缺损相关的信号在临床使用中需要高度关注。
