Drug-Induced Intracranial Pressure Increase: Disproportionality Analysis of the Public Version of the FDA Event Reporting System

IF 2.9 3区医学 Q2 CLINICAL NEUROLOGY Acta Neurologica Scandinavica Pub Date : 2024-10-01 DOI:10.1155/2024/3153568

Caibing Xu, Jinghua Zhang, Yuxia Zhang, Qiuyan Sun, Xuedong Yang, Wei Fang

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Abstract

Objective: This study is aimed at identifying the most common drugs associated with the risk of intracranial pressure increase (IPI) based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: OpenVigil 2.1 was used to query the FAERS database and data from the first quarter of 2004 to the third quarter of 2022 were retrieved. Pharmacovigilance tools were employed for the quantitative detection of signals, where a signal represents a drug-induced adverse event, including the reporting odds ratio (ROR > 1 with 95% confidence interval, the reports number ≥ 2) and proportional reporting ratio (PRR > 2, χ² ≥ 4).

Results: Among the 12,060,031 adverse event reports, there were 3113 cases in which drugs were the primary suspect cause of IPI. Drug-induced intracranial pressure increase (DIPI) was more often observed in young females. The Top 5 drugs with the highest ROR and PRR were minocycline, doxycycline, acetazolamide, somatropin recombinant, and cytarabine.

Conclusion: Potential risks of DIPI should be closely monitored in clinical practice. Our study is consistent with clinical observations, which call for further research to establish the basis of these drugs and IPI.

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药物引起的颅内压增高：FDA 事件报告系统公开版的比例失调分析

研究目的本研究旨在根据美国食品和药物管理局不良事件报告系统（FAERS）数据库，确定与颅内压增高（IPI）风险相关的最常见药物：方法：使用 OpenVigil 2.1 查询 FAERS 数据库，并检索 2004 年第一季度至 2022 年第三季度的数据。采用药物警戒工具定量检测信号，信号代表药物引起的不良事件，包括报告几率比（ROR >1，95%置信区间，报告数≥2）和报告比例比（PRR >2，χ2 ≥4）：在 12 060 031 例不良事件报告中，有 3113 例以药物为 IPI 的主要可疑病因。药物引起的颅内压增高（DIPI）多见于年轻女性。ROR和PRR最高的前5种药物是米诺环素、强力霉素、乙酰唑胺、重组体素和阿糖胞苷：结论：临床实践中应密切关注 DIPI 的潜在风险。我们的研究与临床观察结果一致，需要进一步研究以确定这些药物和 IPI 的基础。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Acta Neurologica Scandinavica 医学-临床神经学

CiteScore

6.70

自引率

2.90%

发文量

161

审稿时长

4-8 weeks

期刊介绍： Acta Neurologica Scandinavica aims to publish manuscripts of a high scientific quality representing original clinical, diagnostic or experimental work in neuroscience. The journal''s scope is to act as an international forum for the dissemination of information advancing the science or practice of this subject area. Papers in English will be welcomed, especially those which bring new knowledge and observations from the application of therapies or techniques in the combating of a broad spectrum of neurological disease and neurodegenerative disorders. Relevant articles on the basic neurosciences will be published where they extend present understanding of such disorders. Priority will be given to review of topical subjects. Papers requiring rapid publication because of their significance and timeliness will be included as ''Clinical commentaries'' not exceeding two printed pages, as will ''Clinical commentaries'' of sufficient general interest. Debate within the speciality is encouraged in the form of ''Letters to the editor''. All submitted manuscripts falling within the overall scope of the journal will be assessed by suitably qualified referees.