Taghaddos Dana, Mihalache Andrew, Huang Ryan S, Popovic Marko M, Chan Clara C
Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Eye (Lond). 2025 Sep 9. doi: 10.1038/s41433-025-03985-x.
Blepharitis, meibomian gland dysfunction (MGD), and chalazia are common disorders impacting quality of life. This population-based, pharmacovigilance study aims to identify systemic drugs disproportionately linked to these disorders.
Data from the Food and Drug Administration Adverse Event Reporting System (FAERS) were analysed (Q4 2003 to Q2 2024). Disproportionality analyses were conducted to identify drugs with ≥10 primary suspect reports for which cases of blepharitis, MGD, or chalazion were overreported, using reporting odds ratios (RORs).
1923 blepharitis, 202 MGD, and 290 chalazion reports were identified. MGD was overreported for finasteride (ROR = 71.6, 95% CI = 37.9-135.3), while chalazion was overreported for bortezomib (ROR = 73.9, 95% CI = 51.4-106.2). All three conditions were overreported for dupilumab (blepharitis: ROR = 35.7, 95% CI = 22.8-55.9; MGD: ROR = 15.4, 95% CI = 7.3-32.5; chalazion: ROR = 12.6, 95% CI = 5.6-28.5). Safety signals, predominantly associated with blepharitis, were also identified for isotretinoin, docetaxel, panitumumab, cetuximab, tretinoin, alendronate, erlotinib, zoledronate, daxibotulinumtoxinA, and infliximab.
This pharmacovigilance study identified associations between several systemic medications with reports of blepharitis, MGD, and chalazion. MGD and chalazion were overreported for finasteride and bortezomib, respectively, whereas all three conditions were overreported for dupilumab. These findings highlight systemic medications as often overlooked contributors to localised eyelid inflammation. Nonetheless, these drugs are known to reduce morbidity and mortality across many diseases. Therefore, while risks may not necessarily outweigh benefits to warrant changes in prescribing practices, clinicians should remain vigilant for such side effects, particularly in patients at higher risk, and to consider prophylactic measures when appropriate, such as educating patients about eyelid hygiene and counselling them to promptly report symptoms.
睑缘炎、睑板腺功能障碍(MGD)和睑板腺囊肿是影响生活质量的常见疾病。这项基于人群的药物警戒研究旨在确定与这些疾病不成比例相关的全身性药物。
分析了美国食品药品监督管理局不良事件报告系统(FAERS)的数据(2003年第四季度至2024年第二季度)。进行了不成比例分析,以确定主要可疑报告≥10份且睑缘炎、MGD或睑板腺囊肿病例报告过多的药物,使用报告比值比(ROR)。
共识别出1923份睑缘炎报告、202份MGD报告和290份睑板腺囊肿报告。非那雄胺的MGD报告过多(ROR = 71.6,95% CI = 37.9 - 135.3),而硼替佐米的睑板腺囊肿报告过多(ROR = 73.9,95% CI = 51.4 - 106.2)。度普利尤单抗的所有三种情况报告均过多(睑缘炎:ROR = 35.7,95% CI = 22.8 - 55.9;MGD:ROR = 15.4,95% CI = 7.3 - 32.5;睑板腺囊肿:ROR = 12.6,95% CI = 5.6 - 28.5)。还确定了异维甲酸、多西他赛、帕尼单抗、西妥昔单抗、维甲酸、阿仑膦酸盐、厄洛替尼、唑来膦酸盐、达昔布妥毒素A和英夫利昔单抗的安全信号,主要与睑缘炎相关。
这项药物警戒研究确定了几种全身性药物与睑缘炎、MGD和睑板腺囊肿报告之间的关联。非那雄胺和硼替佐米分别导致MGD和睑板腺囊肿报告过多,而度普利尤单抗的所有三种情况报告均过多。这些发现突出了全身性药物往往是局部眼睑炎症被忽视的原因。尽管如此,已知这些药物可降低多种疾病的发病率和死亡率。因此,虽然风险不一定超过益处而需要改变处方做法,但临床医生应对此类副作用保持警惕,特别是在高危患者中,并在适当情况下考虑采取预防措施,如对患者进行眼睑卫生教育并建议他们及时报告症状。