关键词: Drug-induced posterior reversible encephalopathy syndrome FAERS PRES adverse drug reaction pharmacovigilance

Mesh : Humans Posterior Leukoencephalopathy Syndrome / chemically induced epidemiology Adverse Drug Reaction Reporting Systems / statistics & numerical data Male Female Retrospective Studies Databases, Factual United States Food and Drug Administration United States / epidemiology Pharmacovigilance Glucocorticoids / administration & dosage adverse effects Middle Aged Adult Immunosuppressive Agents / adverse effects administration & dosage Antineoplastic Agents / adverse effects administration & dosage Adolescent Aged Young Adult Sex Factors Child Drug-Related Side Effects and Adverse Reactions / epidemiology

来  源:   DOI:10.1080/14740338.2024.2327510

Abstract:
UNASSIGNED: In this retrospective pharmacovigilance study, we gathered data on drug-induced posterior reversible encephalopathy syndrome (PRES). Our goal was to identify the primary suspect drugs in PRES by analyzing the Food and Drug Administration Adverse Events Reporting System (FAERS) database.
UNASSIGNED: We identified and analyzed reports of PRES listed in the FAERS database between 2004 and 2021. Using the reporting odds ratio and 95% confidence interval, we evaluated the safety signals for each of the drugs associated with PRES.
UNASSIGNED: We reviewed 11,077 reports of adverse events corresponding to PRES. The primary suspect drug categories were antineoplastics, immunosuppressants, and glucocorticoids. PRES was 24.77% more likely to occur in females than in males. Drug-induced PRES usually occurs in individuals with cancer, those who have undergone an organ/stem cell transplant, and those with autoimmune conditions.
UNASSIGNED: Our results show that the drugs most commonly suspected to cause PRES were antineoplastics, immunosuppressants, and glucocorticoids. Future studies are needed to illuminate the pathophysiological alterations that underlie PRES. In the meantime, prescribers and patients should be made aware of the potential risks of PRES associated with pharmaceutical therapy, and the summaries of product characteristics for individual drugs should be updated to include this information.
摘要:
在这项回顾性药物警戒研究中,我们收集了药物诱发的可逆性后部脑病综合征(PRES)的数据.我们的目标是通过分析食品和药物管理局不良事件报告系统(FAERS)数据库来确定PRES中的主要可疑药物。
我们确定并分析了2004年至2021年FAERS数据库中列出的PRES报告。使用报告赔率比和95%置信区间,我们评估了与PRES相关的每种药物的安全性信号.
我们回顾了与PRES对应的11,077份不良事件报告。主要的可疑药物类别是抗肿瘤药物,免疫抑制剂,和糖皮质激素。女性发生PRES的可能性比男性高24.77%。药物诱导的PRES通常发生在癌症患者中,那些经历过器官/干细胞移植的人,和那些有自身免疫性疾病的人。
我们的研究结果表明,最常怀疑引起PRES的药物是抗肿瘤药物,免疫抑制剂,和糖皮质激素。需要进一步的研究来阐明PRES背后的病理生理改变。同时,处方者和患者应了解与药物治疗相关的PRES的潜在风险,个别药物的产品特征摘要应更新以包含此信息。
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