Safety Analysis of Oxymetazoline Eye Drops for Blepharoptosis Using the FDA Adverse Event Reporting System.

IF 1.3 4区医学 Q3 OPHTHALMOLOGY

Ophthalmic Plastic and Reconstructive Surgery Pub Date : 2026-04-08 DOI:10.1097/IOP.0000000000003226

Daniel B Azzam, John D Hong, Teresa H Chen, Yosur G Alsulaiman, Seanna R Grob, Lilangi S Ediriwickrema, M Reza Vagefi, Jeremiah P Tao

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引用次数: 0

Abstract

Purpose: To analyze the safety of oxymetazoline hydrochloride ophthalmic solution 0.1% for blepharoptosis using real-world Food and Drug Administration Adverse Event Reporting System data.

Methods: This retrospective pharmacovigilance study queried the Food and Drug Administration Adverse Event Reporting System database utilizing OpenVigil 2.1 for oxymetazoline eye drop adverse drug events (ADEs) from Food and Drug Administration approval on January 7, 2020, through April 30, 2025. Disproportionality analysis employed standard methodologies, including reporting odds ratios (RORs) and chi-squared analyses.

Results: Three hundred six patients with 658 ADEs from oxymetazoline eye drop were analyzed, revealing 30 significant safety signals. All ADEs on the drug label were identified in this cohort (multiple RORs, all p < 0.001): ocular surface disease (N = 129, 34.5%), conjunctival hyperemia (N = 43, 11.5%), temporary visual blurring (N = 33, 8.8%), instillation site pain (N = 27, 7.2%), headache (N = 32, 8.6%). Novel ADEs (not on the drug label) were vitreoretinal complications (N = 12, 3.2%, multiple RORs, all p < 0.001)-retinal detachment (N = 3, 0.8%), vitreous detachment (N = 3, 0.8%), vitreous floaters (N = 3, 0.8%), and vitreous hemorrhage (N = 3, 0.8%)-mydriasis (N = 21, 5.6%, ROR 175.4 [112.4-273.7], p < 0.001), hypertension (N = 6, 1.6%, ROR 3.2 [1.4-7.2], p = 0.009), and tachyphylaxis (N = 5, 1.3%, ROR 5.1 [2.1-12.4], p < 0.001).

Conclusions: This Food and Drug Administration Adverse Event Reporting System analysis of oxymetazoline eye drops corroborated prior ADEs, including ocular surface disease, conjunctival hyperemia, transient blurred vision, instillation site pain, and headache. The study revealed new safety signals for vitreoretinal complications, hypertension, mydriasis, and tachyphylaxis. Further studies are warranted to confirm these associations and describe mechanisms such as vitreoretinal traction.

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应用FDA不良事件报告系统对Oxymetazoline滴眼液治疗上睑下垂的安全性进行分析。

目的：利用美国食品药品监督管理局不良事件报告系统的真实数据，分析0.1%盐酸羟甲唑啉眼液治疗上睑下垂的安全性。方法：本回顾性药物警戒研究使用OpenVigil 2.1查询美国食品药品监督管理局不良事件报告系统数据库，查询美国食品药品监督管理局于2020年1月7日至2025年4月30日批准的羟美唑啉滴眼液不良事件（ADEs）。歧化分析采用标准方法，包括报告优势比（RORs）和卡方分析。结果：对306例使用羟美唑啉滴眼液后出现658次不良反应的患者进行分析，发现30个显著的安全信号。在该队列中发现了所有药物标签上的不良反应（多项RORs，均p < 0.001）：眼表疾病（N = 129, 34.5%）、结膜充血（N = 43, 11.5%）、暂时性视力模糊（N = 33, 8.8%）、滴注部位疼痛（N = 27, 7.2%）、头痛（N = 32, 8.6%）。埃兹的小说(不服用抗抑郁药物的标签)适应症并发症(N = 12, 3.2%,多个ROR,所有p < 0.001)视网膜脱离(N = 3, 0.8%),玻璃体脱离(N = 3, 0.8%),玻璃飞蚊症(N = 3, 0.8%),和玻璃体出血(N = 3, 0.8%)瞳孔放大(N = 21日5.6%,ROR 175.4 (112.4 - -273.7), p < 0.001),高血压(N = 6 1.6%, ROR 3.2 [1.4 - -7.2], p = 0.009),和急速免疫法(N = 5, 1.3%, ROR 5.1 (2.1 - -12.4), p < 0.001)。结论：美国食品和药物管理局对羟美唑啉滴眼液不良事件报告系统的分析证实了其既往不良事件，包括眼表疾病、结膜充血、短暂性视力模糊、滴注部位疼痛和头痛。该研究揭示了玻璃体视网膜并发症、高血压、散瞳和快速反应的新安全信号。需要进一步的研究来证实这些关联，并描述诸如玻璃体视网膜牵引力的机制。

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来源期刊

Ophthalmic Plastic and Reconstructive Surgery 医学-外科

CiteScore

2.50

自引率

10.00%

发文量

322

审稿时长

3-8 weeks

期刊介绍： Ophthalmic Plastic and Reconstructive Surgery features original articles and reviews on topics such as ptosis, eyelid reconstruction, orbital diagnosis and surgery, lacrimal problems, and eyelid malposition. Update reports on diagnostic techniques, surgical equipment and instrumentation, and medical therapies are included, as well as detailed analyses of recent research findings and their clinical applications.