2026-04-09 10:02:48 UTC / 路透社
作者:Mrinalika Roy 与 Sriparna Roy
2026年4月9日 美国东部时间上午10:02 更新于1小时前
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Item 1 of 3 2026年3月29日,在美国科罗拉多州柯林斯堡,接受激素替代疗法(HRT)的艾米·萨特伦德拍摄肖像照。路透社/Cheney Orr
[1/3]2026年3月29日,在美国科罗拉多州柯林斯堡,接受激素替代疗法(HRT)的艾米·萨特伦德拍摄肖像照。路透社/Cheney Orr 购买授权许可,打开新标签页
- 内容摘要
- 相关企业
- 安全警告放宽、对激素替代疗法看法转变推动使用量飙升
- 患者反映辗转多家药房、调整用药剂量
- 生产商称复杂生产流程限制快速扩产
4月9日(路透社)——去年以来,用于缓解更年期症状的雌激素贴片需求激增导致供应紧张,进而引发药品短缺。业内人士称,此次短缺可能持续长达三年。
美国每年有超过100万女性进入更年期。过去两年间,越来越多女性寻求使用雌激素贴片治疗情绪波动、潮热和睡眠障碍。社交媒体尤其成为了转变人们对这类药物安全性与益处看法的平台。
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美国食品药品监督管理局(FDA)去年7月开始公开称赞激素替代疗法为“救命疗法”,并于去年11月移除了这类疗法长期存在的安全警告。健康数据与分析公司Truveta的数据显示,FDA立场转变后,截至今年2月,雌激素贴片的使用量跃升了26%。
“去年11月FDA移除安全警告后,需求出现了前所未有的增长,目前无法完全满足,”瑞士仿制药生产商山德士(Sandoz SDZ.S)的一位发言人表示。该公司已向美国追加发货以缓解短缺。
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雌激素贴片是一种激素替代疗法,通过皮肤直接将雌激素输送至血液。
“20年来,接受激素治疗的女性不到5%。如今这一数字正在增长……而扩大药物生产并不像看起来那么容易,”纽约大学格罗斯曼医学院兼职助理吉利安·戈达德博士说道。
尽管FDA尚未将雌激素贴片列为短缺药品,但据对六名患者、三家远程医疗公司和六名行业专家的采访显示,女性正辗转多家药房寻找贴片,减少剂量、更换用药方案,或是更换品牌或疗法类型。
医生表示,突然停药可能会使症状复发,而更换品牌则可能带来新的副作用。
每千名女性激素替代疗法配药情况(按类型)
寻药之路
50岁的艾米·萨特伦德是科罗拉多州皮尔斯堡的一名产品经理,她使用雌激素贴片已有约18个月,但近期很难买到。
她说自己不得不提前规划CVS药房的备货情况,并且在在线药房Cost Plus Drugs等候许久。
“如果无法续方,我会很担心,担心副作用或围绝经期症状会复发,”萨特伦德说道。
CVS健康公司(CVS.N)的一位发言人表示,近期几周生产商无法提供足够数量的药品。
Cost Plus的一位发言人表示,该公司已增加备货以应对激增的需求,但尚未从供应商处得知短缺会持续较长时间。
负责监管FDA的美国卫生与公众服务部发言人安德鲁·尼克松表示,该机构正与企业协调,支持增加贴片供应的工作。
指南调整 需求攀升
FDA局长马蒂·马卡里去年7日扭转了此前对激素替代疗法的谨慎态度。在采访和帖子中,他表示此前因癌症风险建议女性避免使用这类疗法,但如今科学证据已发生变化。
2002年的《妇女健康倡议》研究曾将激素疗法与某些癌症、痴呆症、心脏病发作和中风的风险增加联系起来。如今,美国妇产科医师学会在其网站上指出了各类激素替代疗法的风险与益处,并建议使用这类疗法的患者每年与医生沟通是否继续治疗。
Truveta的电子健康记录数据库覆盖全美50个州的1.3亿多名患者。该公司的数据显示,近年来大多数激素替代疗法的使用量均有所上升,其中雌激素贴片的使用量自2023年以来飙升184%,涨幅最大。同期阴道乳膏型激素替代疗法的使用量增长了122%。
对在此期间曾接受过任何医疗处方的女性进行分析后发现,截至2026年2月,约每100名45至54岁女性中就有5人开具了雌激素类激素替代疗法处方,这一数字自2023年以来几乎翻倍。
帮助患者获取激素疗法和医师咨询的远程医疗平台HRT Club表示,自FDA去年11月采取行动以来,贴片销售额增长了150%。
美国雌激素贴片销量近年飙升
生产瓶颈
雌激素贴片属于低利润率的仿制药,生产商几乎没有动力快速投资建设新生产线或设施——这类设施往往需要数年才能建成。
行业消息人士和医生表示,长期供货合同也会阻碍生产商快速调整以应对需求变化。
美国卫生系统药师协会的数据显示,包括Amneal(AMRX.O)、Zydus(ZYDU.NS)、山德士、Noven和Viatris(VTRS.O)在内的主要贴片生产商,部分剂型均出现短缺。
Amneal和Viatris表示,他们正努力增加贴片供应以满足需求。Zydus和Noven未回应置评请求。
哥伦比亚大学妇产科医师、综合女性健康项目主任玛丽·罗瑟博士表示,FDA确实有办法缓解短缺,包括要求生产商建立更多元化的备用供应链,强制要求最低库存和主动库存监控系统。
FDA拒绝就此类选项置评。
“人们花了很长时间才做出是否使用激素的决定,”罗瑟说道,“然后他们做出了决定,却买不到药。”
由Mrinalika Roy、Mariam Sunny和Sriparna Roy在班加罗尔报道;Caroline Humer与Bill Berkrot编辑
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Patients scramble to find estrogen patches as shortage worsens after US FDA champions use
2026-04-09 10:02:48 UTC / Reuters
By Mrinalika Roy and Sriparna Roy
April 9, 2026 10:02 AM UTC Updated 1 hour ago
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Item 1 of 3 Amy Satterlund, who is on hormone replacement therapy (HRT), poses for a portrait, in Fort Collins, Colorado, U.S., March 29, 2026. REUTERS/Cheney Orr
[1/3]Amy Satterlund, who is on hormone replacement therapy (HRT), poses for a portrait, in Fort Collins, Colorado, U.S., March 29, 2026. REUTERS/Cheney Orr Purchase Licensing Rights, opens new tab
- Summary
- Companies
- Easing safety warnings, shift in sentiment toward HRT trigger sharp increases in use
- Patients report pharmacy-hopping and dose changes
- Manufacturers say complex production limit rapid scale-up
April 9 (Reuters) – A surge in demand since last year for estrogen patches to ease menopause symptoms has strained supplies and led to shortages, sparking a scramble for medicines that industry sources say could last up to three years.
More than 1 million U.S. women begin menopause each year. Over the past two years they have increasingly sought out estrogen patches to treat mood swings, hot flashes and sleep disturbances. Social media in particular has been a forum for changing views on the medicines’ safety and benefits.
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The U.S. FDA began publicly extolling hormone replacement therapy as “lifesaving” last July, and in November it removed a longstanding safety warning from the therapies. The change in the Food and Drug Administration’s stance was followed by a 26% jump in patch use through February, according to data from health data and analytics company Truveta, opens new tab.
“When the FDA removed the safety warning in November, it created unprecedented demand that cannot fully be met at present,” said a spokesperson for Swiss generics manufacturer Sandoz SDZ.S, which has shipped additional supplies to the U.S. to help ease shortages.
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The patches are a type of hormone replacement therapy that delivers estrogen directly through the skin into the bloodstream.
“For 20 years, less than 5% of women took hormone therapy. Now those numbers are growing… and scaling up production of medications is not as easy as it might seem,” said Dr. Gillian Goddard, adjunct assistant professor at the NYU Grossman School of Medicine.
While the FDA has not designated the patches as being in shortage, women are pharmacy-hopping in search of them, reducing or switching dosages and changing brands or types of therapy, according to interviews with six patients, three telehealth companies, and six industry experts.
Abruptly stopping use can restart symptoms, while switching brands may bring new side effects, doctors said.
Hormone Replacement Therapy Dispenses per 1000 Women By Type
SEARCHING FOR SUPPLY
Amy Satterlund, 50, a product manager from Fort Pierce, Colorado, has been using the estrogen patch for about 18 months, but has recently struggled to find it.
She said she has had to plan for shortages at CVS pharmacies and long waits at online pharmacy Cost Plus Drugs.
“I do get nervous if I were unable to get my prescription refilled, that side effects or that the symptoms of perimenopause would come back,” Satterlund said.
A CVS Health CVS.N spokesperson said manufacturers have been unable to deliver sufficient quantities in recent weeks.
A Cost Plus spokesperson said it has added supply to keep up with exploding demand, but hasn’t heard from its suppliers on shortages lasting for an extended period of time.
Andrew Nixon, a spokesman for the U.S. Health and Human Services Department, which oversees the FDA, said the agency is coordinating with companies to support efforts to boost the supply of patches.
CHANGING GUIDANCE, RISING DEMAND
FDA Commissioner Marty Makary last July turned the tables on previous cautions against HRT use. In interviews and postings, he said women had been advised against the treatments due to cancer risks, but that the scientific evidence has changed.
The 2002 Women’s Health Initiative study had linked hormone therapy to increased risks for some cancers, dementia, heart attacks and stroke. Now, the American College of Obstetricians and Gynecologists on its website notes risks and benefits to the various types of HRT and advises patients who use them to talk with their doctor every year about whether to continue.
Hormone Replacement Therapy Prescriptions Per 1000 Women
Using its electronic health record database covering more than 130 million patients in all 50 states, Truveta found use of most forms of HRT has climbed in recent years, with the sharpest increase a 184% jump in estrogen patches since 2023. Vaginal cream HRT use rose 122% over the same period.
By February 2026, about 5 out of 100 women aged 45-54 had been prescribed estrogen-based HRT, roughly doubling since 2023, based on an analysis of women who had received any medical prescription during that period.
Telehealth platform HRT Club, which helps patients access hormone therapies and physicians, said patch sales had risen 150% since the FDA’s November actions.
U.S. Estrogen Patch Sales Have Surged In Recent Years
MANUFACTURING BARRIERS
Estrogen patches are generic medicines with low profit margins, providing manufacturers few incentives to invest quickly in new production lines or facilities that can take years to build.
Long-term contracts for supplies can also hinder manufacturers from quickly adjusting to demand changes, industry sources and doctors said.
Major makers of the patches, including Amneal AMRX.O, Zydus ZYDU.NS, Sandoz, Noven, and Viatris VTRS.O, all have some doses in shortage, according to the American Society of Health-System Pharmacists.
Amneal and Viatris said they were trying to boost patch supply to meet demand. Zydus and Noven did not respond to a request for comment.
Dr. Mary Rosser, an Ob-Gyn and director of Integrated Women’s Health at Columbia University, said the FDA does have ways to mitigate shortages. These could include requiring manufacturers to have more diverse and back-up supply chains, and mandating minimum inventories and proactive inventory monitoring systems, she said.
The FDA declined to comment on such options.
“People have waited a long time to make a decision… about whether they want to use hormones,” Rosser said. “Then they make the decision and then they can’t get them.”
Reporting by Mrinalika Roy, Mariam Sunny, and Sriparna Roy in Bengaluru; Editing by Caroline Humer and Bill Berkrot
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