Department of Neurosurgery, Allegheny General Hospital, 320 E North Ave, Pittsburgh, PA 15212, USA; Department of Neurology, Medical College of Wisconsin, 8701 W Watertown Plank Rd, Milwaukee, WI 53226, USA.
Department of Neurology, Medical College of Wisconsin, 8701 W Watertown Plank Rd, Milwaukee, WI 53226, USA.
Epilepsy Res. 2024 Jul;203:107382. doi: 10.1016/j.eplepsyres.2024.107382. Epub 2024 May 17.
Pharmacovigilance systems such as the FDA Adverse Event Reporting System (FAERS), are established models for adverse event surveillance that may have been missed during clinical trials. We aimed to analyze twenty-five anti-seizure medications (ASMs) in FAERS to assess for increased reporting of suicidal and self-injurious behavior.
Twenty-five ASMs were analyzed: brivaracetam, cannabidiol, carbamazepine, clobazam, clonazepam, diazepam, eslicarbazepine, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, perampanel, phenobarbital, phenytoin, pregabalin, primidone, rufinamide, stiripentol, tiagabine, topiramate, valproate, vigabatrin, zonisamide. Reports of "suicidal and self-injurious behavior" were collected from January 1, 2004, to December 31, 2020, using OpenVigil 2.1 tool with indication as "Epilepsy". Relative reporting ratio, proportional reporting ratio, and reporting odds ratio were calculated utilizing all other drug reports for epilepsy patients as a control.
Significant relative operating ratio, ROR (greater than 1, p<0.05) were observed for diazepam (2.909), pregabalin (2.739), brivaracetam (2.462), gabapentin (2.185), clonazepam (1.649), zonisamide (1.462), lacosamide (1.333), and levetiracetam (1.286).
Of the 25 ASMs that were analyzed in this study, 4 (16%) were identified to have been linked with a likely true adverse event. These drugs included diazepam, brivaracetam, gabapenetin, and pregabalin. Although several limitations are present with the FAERS database, it is imperative to closely monitor patient comorbidities for increased risk of suicidality with the use of several ASMs.
药物警戒系统（如 FDA 不良事件报告系统（FAERS））是用于监测不良事件的成熟模型，这些模型可能会在临床试验期间被忽视。我们旨在分析 FAERS 中的 25 种抗癫痫药物（ASM），以评估自杀和自残行为的报告是否增加。
分析了 25 种 ASM：布瓦加宾、大麻二醇、卡马西平、氯巴占、氯硝西泮、地西泮、依佐加滨、非氨酯、加巴喷丁、拉科酰胺、拉莫三嗪、左乙拉西坦、奥卡西平、吡仑帕奈、苯巴比妥、苯妥英、普瑞巴林、苯琥胺、鲁非酰胺、司替戊醇、噻加宾、托吡酯、丙戊酸、维加特林、左乙拉西坦。从 2004 年 1 月 1 日至 2020 年 12 月 31 日，使用 OpenVigil 2.1 工具，以“癫痫”为适应症，收集“自杀和自残行为”的报告。利用所有其他癫痫患者的药物报告作为对照，计算相对报告比值（RRR）、比例报告比值（PRR）和报告比值比（ORR）。
观察到地西泮（2.909）、普瑞巴林（2.739）、布瓦加宾（2.462）、加巴喷丁（2.185）、氯硝西泮（1.649）、佐尼沙胺（1.462）、拉科酰胺（1.333）和左乙拉西坦（1.286）的相对操作比（RRR）显著升高（大于 1，p<0.05）。
在本研究分析的 25 种 ASM 中，有 4 种（16%）被确定与可能的真实不良事件相关。这些药物包括地西泮、布瓦加宾、加巴喷丁和普瑞巴林。尽管 FAERS 数据库存在一些局限性，但必须密切监测使用几种 ASM 时自杀风险增加的患者合并症。
