再有3款更年期激素治疗产品删去过时风险警告：食品药品监管局批准更新标签，贴片产量一年翻倍
美国卫生与公众服务部（Department of Health and Human Services，HHS）10月30日在华盛顿宣布，食品药品监管局（Food and Drug Administration，FDA）已批准另外3款更年期激素治疗（menopausal hormone therapy，MHT）产品更新标签，并同步通报扩大这类治疗产能与供应可及性的进展。此次获批的产品来自两家申请人，均为雌二醇透皮贴片。
此次更新删去的是这3款产品黑框警告中与现行科学认识不符的过时表述，涉及心血管疾病、乳腺癌与可能痴呆的风险表述。今年2月，FDA 已批准6款更年期激素治疗产品作同类标签修改；FDA 说明，本次调整源于对科学文献的全面复查，以及对这类疗法获益与风险特征的最新信息。
卫生与公众服务部长 Robert F. Kennedy, Jr. 表示，删去这些黑框警告中的过时表述是妇女健康的一项重大进展，联邦政府正在改变更年期护理的做法：按现行科学更新标签、直面治疗障碍，并与生产企业合作扩大供应。医疗保险与医疗补助服务中心（Centers for Medicare & Medicaid Services，CMS）主任 Dr. Mehmet Oz 表示，这一步推进了对妇女健康的支持。
第一夫人 Melania Trump 是推动相关行政令与工作组的倡议者。她表示，现在正是让美国的资源聚焦女孩与妇女的时候，将通过其妇女健康创新平台加速创新、推动与私营部门的务实合作，造福美国妇女。HHS 说明，今天的标签行动落实的是特朗普总统10月19日签署的行政令《在人生各阶段推进妇女健康、改善结局》（Advancing Women's Health to Improve Outcomes in All Phases of Life）。
供应方面，FDA 代局长 Kyle Diamantas 表示，当妇女与医生共同决定激素治疗适合本人时，应当能够获得治疗，这意味着既要推进最新标签，也要保障可及性。FDA 自2025年11月起与企业沟通提交标签补充修订，至今已有29家药企提交拟议修改；该局预计需求上升，已提前与全部获批更年期激素治疗制剂的生产商保持密切联系，目前未发现全国性短缺的迫近风险。
FDA 介绍，雌二醇透皮贴片的全部6家生产商都在应对需求大增带来的可及性挑战，措施包括扩产、增加生产班次与优先安排贴片产量，过去12个月这类产品整体产量已经翻倍；凝胶、乳膏等其他剂型的供应也在持续监测中。该局还表示，正与申请人研究阴道雌激素产品转为非处方药的可能性，任何此类转换都须经 FDA 批准，并有证据证明消费者能在无医务人员监督下恰当选择与安全使用。
FDA 同时提醒，市面可及性会因品牌、剂量、剂型（每周一次或每周两次）与地区而异；买不到常用贴片产品的妇女可与药剂师或医务人员沟通，寻找适合个人情况的替代产品。
Three More Menopausal Hormone Therapy Products Lose Outdated Boxed Warnings: FDA Approves Label Updates and Says Patch Output Has Doubled in a Year
The U.S. Department of Health and Human Services (HHS) announced in Washington on October 30 that the Food and Drug Administration (FDA) has approved updated labeling for three additional menopausal hormone therapy (MHT) products from two applicants, and gave an update on efforts to expand manufacturing capacity and availability of these therapies. The three products are estradiol transdermal patches.
The updates remove outdated statements about cardiovascular disease, breast cancer, and probable dementia from the boxed warning sections of the three products. In February 2026, FDA approved labeling changes for six menopausal hormone therapy products to clarify benefit-risk considerations; HHS said today's changes reflect a thorough re-examination of the scientific literature and updated information on the benefit-risk profile of these therapies.
HHS Secretary Robert F. Kennedy, Jr. said removing outdated statements from these boxed warnings marks a major victory for women's health, and that the federal government is changing how it approaches menopause care by updating labels to reflect current science, confronting barriers to treatment, and working with manufacturers to expand supply. CMS Administrator Dr. Mehmet Oz said the announcement is an important step forward in supporting women's health.
First Lady Melania Trump was the impetus behind the executive order and task force behind the effort, and said now is the time for America's resources to focus on girls and women, adding that her Women's Health Innovation platform will accelerate innovation and common-sense partnerships with the private sector to benefit America's women. HHS said today's labeling actions support President Trump's Executive Order, Advancing Women's Health to Improve Outcomes in All Phases of Life, signed on October 19, 2026.
On supply, Acting FDA Commissioner Kyle Diamantas said that when women and their doctors determine hormone therapy is right for them, they should be able to access it, which means advancing both up-to-date labeling and access to treatment. FDA began engaging companies in November 2025 to submit proposed supplemental labeling revisions, and 29 drug companies have submitted proposed changes to date. Anticipating increased demand, FDA is in close contact with manufacturers of all approved MHT formulations and is not aware of an imminent risk of a nationwide shortage.
FDA said all six manufacturers of approved estradiol transdermal patches are addressing access challenges driven by a significant rise in demand, with expanded production capacity, additional manufacturing shifts, and prioritized patch output resulting in an overall doubling of market output in the last 12 months, while supply of other dosage forms such as gels and creams continues to be monitored. The agency is also working with sponsors to explore potential over-the-counter availability of vaginal estrogen products, a switch that would require FDA approval supported by evidence that consumers can appropriately select and use the products safely without a healthcare professional's supervision.
FDA noted that availability can vary by brand, strength, formulation (once-weekly versus twice-weekly), and geographic location, and encouraged women having difficulty finding their usual patch product to speak with their pharmacist or healthcare provider about an available alternative or equivalent option appropriate for their individual needs.
来源：GSM·美国（原文链接）
图片来源：图：美国食品药品监管局白橡树园区一号大楼（马里兰州 Silver Spring），美国食品药品监管局，公共领域。 / FDA Building 1 at the White Oak Campus in Silver Spring, Maryland, U.S. Food and Drug Administration, public domain.
