食品药品管理局要求全部 GLP-1 类药物改标签 加注罕见严重眼病风险
华盛顿 — 美国食品药品管理局（FDA）11 月 9 日在华盛顿发布药品安全通告，要求全部 GLP-1 受体激动剂类药物的申请持有人修改药品标签，在「警告与注意事项」一节加注非动脉炎性前部缺血性视神经病变（NAION）的风险信息。这类药物用于治疗糖尿病与减重，在美国使用广泛。
食品药品管理局说，目前市面上全部 GLP-1 类产品都已有 NAION 病例报告。该局综合临床试验数据、动物数据与上市后数据（包括观察性研究与病例报告）评估后认定，服用 GLP-1 类药物的患者出现这种罕见 NAION 事件的风险可能升高，据此要求全部同类药物统一修改标签。
临床试验数据方面，该局汇总了 126 项 GLP-1 类药物临床试验、共 134,253 名患者（其中 78,217 人使用 GLP-1 类药物、56,036 人使用对照药物）：共确认 15 例可能的 NAION 事件，其中 10 例出现在 GLP-1 类药物使用者身上、5 例出现在安慰剂组。按发病率计，GLP-1 类药物组为每 10 万人年 6.4 例，对照组为每 10 万人年 3.8 例。
真实世界数据方面，该局利用 Sentinel 真实世界证据数据企业商业网络回溯了 2019 年至 2024 年开始用药的成年 2 型糖尿病患者：GLP-1 类药物组的 NAION 发病率为每 10 万人年 30 至 32 例。与 SGLT-2 抑制剂相比，风险比为 1.19，差异没有统计学意义；与 DPP-4 抑制剂相比，风险比为 1.43，风险升高。该局说，已发表的观察性研究结果与上述分析大体一致。
这次评估源于 2024 年 7 月发表的一项研究，该研究提出使用司美格鲁肽的患者 NAION 风险可能升高。食品药品管理局说，该研究有若干局限，但风险值得进一步评估；对动物数据的审查没有找到 GLP-1 类药物升高 NAION 风险的作用机制。
关联：研究：GLP-1类减重糖尿病药物与罕见视力丧失风险小幅上升相关
（来源：美国食品药品管理局）
FDA Requires Labeling Changes for All GLP-1 Drugs Over Risk of Rare, Serious Eye Condition
WASHINGTON — The U.S. Food and Drug Administration (FDA) issued a drug safety communication in Washington on November 9 requiring the application holders of all glucagon-like peptide-1 receptor agonist (GLP-1 RA) medicines to change their labeling, adding information about the risk of non-arteritic anterior ischemic optic neuropathy (NAION) to the Warnings and Precautions section. The drugs are widely used in the United States to treat diabetes and for weight loss.
The FDA said NAION cases have been reported for all currently marketed GLP-1 RA products. After a comprehensive evaluation of clinical trial data, animal data and postmarketing data, including observational studies and case reports, the agency concluded that there is a potential increased risk of rare NAION events in patients taking GLP-1 RAs, and is requiring the labeling change for all of them.
In its meta-analysis of clinical trials, the FDA pooled 126 trials across GLP-1 RA development programs covering 134,253 patients, of whom 78,217 used a GLP-1 RA and 56,036 received a comparator. It identified 15 probable NAION events: 10 in patients treated with GLP-1 RAs and 5 in patients receiving placebo. The NAION incidence rate was 6.4 events per 100,000 person-years in patients treated with GLP-1 RAs, compared with 3.8 per 100,000 person-years in comparator-treated patients.
In a retrospective cohort study in the FDA's Sentinel Real-World Evidence Data Enterprise Commercial Network, covering adults with type 2 diabetes who started a GLP-1 RA or another common diabetes medication between 2019 and 2024, NAION incidence rates ranged from 26 to 32 events per 100,000 person-years, with GLP-1 RAs at 30 to 32. Compared with SGLT-2 inhibitors, the hazard ratio was 1.19, which was not statistically significant; compared with DPP-4 inhibitors, the hazard ratio was 1.43, an increased risk. The FDA said methodologically rigorous published observational studies were generally consistent with these findings.
The review followed a study published in July 2024 that raised the possibility of an increased NAION risk in patients prescribed semaglutide. The FDA said it identified several limitations in that study but determined further assessment was warranted, and that its review of animal data did not identify a mechanism for how GLP-1 RA use could increase the potential risk.
Related: Study Links GLP-1 Weight-Loss and Diabetes Drugs to Slightly Higher Risk of Rare Vision Loss
(Source: U.S. Food and Drug Administration)
来源：美国食品药品管理局
发布：GSM·美国（发布链接）
图片来源：图：美国食品药品管理局总部大楼（GSM 固定图库）。 / Photo: U.S. Food and Drug Administration headquarters (GSM asset library).
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