关键词: Priapism anti-seizure medications disproportionality analysis literature review signal

Mesh : Male Humans United States Pharmacovigilance Priapism / chemically induced Anticonvulsants / adverse effects Gabapentin / adverse effects Levetiracetam Adverse Drug Reaction Reporting Systems United States Food and Drug Administration

来  源:   DOI:10.1080/14740338.2023.2293208

Abstract:
UNASSIGNED: Recently, case reports of priapism associated with the use of some anti-seizure medications began to emerge in the literature. We aimed to investigate if there is a potential safety signal of priapism among individual anti-seizure medications and to search the literature for relevant published cases.
UNASSIGNED: We conducted a disproportionality analysis using OpenVigil 2.1 to query the United States Food and Drug Administration\'s Adverse Event Reporting System (FAERS) database. Literature search was conducted in PubMed/MEDLINE, Scopus and Web of Science up to 12 July 2023.
UNASSIGNED: We identified positive signal of priapism for valproic acid and its derivatives (n = 23, chi-squared = 59.943, PRR = 4.566), gabapentin (n = 20, chi-squared = 9.790, PRR = 2.060), lamotrigine (n = 16, chi-squared = 8.318, PRR = 2.120), levetiracetam (n = 16, chi-squared = 10.766, PRR = 2.329), topiramate (n = 14, chi-squared = 28.067, PRR = 3.972) and carbamazepine (n = 8, chi-squared = 6.147, PRR = 2.568), as well as published cases of priapism associated with these drugs. We also found published cases of priapism for pregabalin and phenytoin in the literature and FAERS, and at least one reported adverse event of priapism in FAERS for clonazepam, lacosamide, ethosuximide, oxcarbazepine, and vigabatrin in which they were considered primary suspect.
UNASSIGNED: Our study identified signals for priapism for several anti-seizure medications, but these results need to be confirmed in well-designed pharmacoepidemiological studies.
摘要:
最近,文献中开始出现与使用某些抗癫痫药物相关的阴茎异常勃起的病例报告.我们旨在调查个体抗癫痫药物中是否存在阴茎异常勃起的潜在安全信号,并在文献中搜索相关已发表的病例。
我们使用OpenVigil2.1进行了不相称性分析,以查询美国食品和药物管理局的不良事件报告系统(FAERS)数据库。文献检索在PubMed/MEDLINE进行,截至2023年7月12日,Scopus和WebofScience。
我们确定了丙戊酸及其衍生物的阴茎异常勃起的阳性信号(n=23,卡方=59.943,PRR=4.566),加巴喷丁(n=20,卡方=9.790,PRR=2.060),拉莫三嗪(n=16,卡方=8.318,PRR=2.120),左乙拉西坦(n=16,卡方=10.766,PRR=2.329),托吡酯(n=14,卡方=28.067,PRR=3.972)和卡马西平(n=8,卡方=6.147,PRR=2.568),以及与这些药物相关的已发表的阴茎异常勃起病例。我们还在文献和FAERS中发现了已发表的普瑞巴林和苯妥英的阴茎异常勃起病例,以及FAERS中氯硝西泮的至少一次报告的阴茎异常勃起不良事件,拉科沙胺,乙苏肟,奥卡西平,和vigabatrin,他们被认为是主要嫌疑人。
我们的研究确定了几种抗癫痫药物的阴茎异常勃起信号,但这些结果需要在精心设计的药物流行病学研究中得到证实.
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