药物致盲?一个连接semaglutide和NAION的警戒信号。

IF 1.4 4区 医学 Q3 OPHTHALMOLOGY
Jaishree Suresh, Kalaiselvan Vivekanandan
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引用次数: 0

摘要

简介:Semaglutide,作为Ozempic, Wegovy和Rybelsus广泛使用,由于其有益的药物不良反应和在不同人群中更安全的使用,显著改善了2型糖尿病和肥胖的管理。然而,随着它的广泛使用,罕见但严重的副作用正在浮出水面。非动脉性前缺血性视神经病变(NAION)是一种引起突然的、通常是不可逆的视力丧失的疾病。方法:使用从VigiBase®收集的数据进行回顾性上市后观察研究,直至2025年6月,使用监管活动医学词典(MedDRA)中的映射术语。结果:在全球报告的73636例与Semaglutide相关的不良反应的个案安全报告(icsr)中,91例与NAION相关。全球均有病例报告,丹麦(N = 38, 41.80%)、澳大利亚(N = 9, 9.90%)和法国(N = 7, 7.70%)报告病例数增加,主要患者年龄为45-74岁(N = 50, 54.90%)。重症病例多(97.80%),以男性为主。共同报告的反应包括严重的“眼睛相关”情况,如视力障碍(N = 12,13.20%)、失明(N = 9,9.90%)、视野缺损(N = 5,5.50%)、视神经萎缩(N = 4,4.40%)、视力模糊(N = 4,4.40%)等严重反应。结论:这项研究提高了人们对西马鲁肽罕见但重要的安全性问题的认识。早期发现NAION症状并及时停药可能是预防永久性视力丧失的关键。此外,应在患者信息单张/药物产品特性摘要中提及反应,以提高医疗保健提供者和服用该药物的消费者的认识。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Blinded by the drug? A vigilyze signal linking semaglutide to NAION.

Introduction: Semaglutide, available widely as Ozempic, Wegovy, and Rybelsus, has significantly improved the management of type 2 diabetes and obesity due to its beneficial adverse drug reactions and safer use in diverse population. However, as its use grows widely, rare but serious side effects are coming to light. One such emerging concern is Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION), a condition causing sudden, often irreversible vision loss.

Methodology: A retrospective, post-market observational study was conducted using data collected from VigiBase® until June 2025, using mapped terms under Medical Dictionary for Regulatory Activities (MedDRA).

Result: Of 73,636 global Individual Case Safety Reports (ICSRs) related to Semaglutide reported adverse reactions globally, 91 were associated with the adverse reaction NAION. The cases were reported globally with increased number of cases reported by Denmark (N = 38, 41.80%), Australia (N = 9, 9.90%) and France (N = 7, 7.70%), primarily affected patients aged 45-74 years (N = 50, 54.90%). Most cases (97.80%) were classified as serious with a significant of the cases reported of males. The co-reported reactions involved serious 'eye-related' conditions like Visual Impairment (N = 12,13.20%), Blindness (N = 9, 9.90%), Visual field defect (N = 5, 5.50%), Optic atrophy (N = 4, 4.40%), Vision blurred (N = 4, 4.40%) among other serious reactions.

Conclusion: This study raises awareness of a rare yet significant safety concern with Semaglutide. Early detection of NAION symptoms and timely drug discontinuation may be critical in preventing permanent vision loss. Moreover, the reaction should be mentioned in the patient information leaflet/ summary of the product characteristic of the drug to create awareness among the healthcare providers as well as the consumers taking the drug.

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来源期刊
CiteScore
3.20
自引率
0.00%
发文量
451
期刊介绍: International Ophthalmology provides the clinician with articles on all the relevant subspecialties of ophthalmology, with a broad international scope. The emphasis is on presentation of the latest clinical research in the field. In addition, the journal includes regular sections devoted to new developments in technologies, products, and techniques.
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