Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
摘要：
背景：药物警戒系统，如FDA不良事件报告系统（FAERS），是在临床试验中可能遗漏的不良事件监测建立的模型。我们旨在分析FAERS中的25种抗癫痫药物（ASM），以评估自杀和自我伤害行为的增加报告。
方法：对25个ASM进行了分析：布立西坦，大麻二酚,卡马西平,Clobazam,氯硝西泮,地西泮,艾司利卡西平,felbamate,加巴喷丁,拉科沙胺,拉莫三嗪,左乙拉西坦,奥卡西平,Perampanel,苯巴比妥,苯妥英,普瑞巴林,普米酮,鲁非酰胺,stiripentol,Tiagabine,托吡酯,丙戊酸盐,vigabatrin,唑尼沙胺.从2004年1月1日至2020年12月31日，使用OpenVigil2.1工具收集了“自杀和自我伤害行为”的报告，指示为“癫痫”。相对报告比率，比例报告比率，使用所有其他癫痫患者的药物报告作为对照,计算报告比值比.
结果：显著的相对运行比率，观察到地西泮的ROR（大于1，p<0.05）（2.909），普瑞巴林（2.739），布立西坦（2.462），加巴喷丁（2.185），氯硝西泮（1.649），唑尼沙胺（1.462），拉科沙胺（1.333），和左乙拉西坦（1.286）。
结论：在本研究中分析的25个ASM中，4（16％）被确定与可能的真实不良事件有关。这些药物包括地西泮,布立西坦,加巴霉素,还有普瑞巴林.尽管FAERS数据库存在一些限制，在使用多个ASM的情况下,必须密切监测患者合并症是否增加自杀风险.
方法：对25个ASM进行了分析：布立西坦，大麻二酚,卡马西平,Clobazam,氯硝西泮,地西泮,艾司利卡西平,felbamate,加巴喷丁,拉科沙胺,拉莫三嗪,左乙拉西坦,奥卡西平,Perampanel,苯巴比妥,苯妥英,普瑞巴林,普米酮,鲁非酰胺,stiripentol,Tiagabine,托吡酯,丙戊酸盐,vigabatrin,唑尼沙胺.从2004年1月1日至2020年12月31日，使用OpenVigil2.1工具收集了“自杀和自我伤害行为”的报告，指示为“癫痫”。相对报告比率，比例报告比率，使用所有其他癫痫患者的药物报告作为对照,计算报告比值比.
结果：显著的相对运行比率，观察到地西泮的ROR（大于1，p<0.05）（2.909），普瑞巴林（2.739），布立西坦（2.462），加巴喷丁（2.185），氯硝西泮（1.649），唑尼沙胺（1.462），拉科沙胺（1.333），和左乙拉西坦（1.286）。
结论：在本研究中分析的25个ASM中，4（16％）被确定与可能的真实不良事件有关。这些药物包括地西泮,布立西坦,加巴霉素,还有普瑞巴林.尽管FAERS数据库存在一些限制，在使用多个ASM的情况下,必须密切监测患者合并症是否增加自杀风险.
