Lea Didion，45岁，在40多岁出现更年期症状后开始荷尔蒙替代疗法，并报告了明显改善：关节疼痛消退、精力提高、肠胃不适减轻。她的案例反映了美国的转变：FDA放宽了荷尔蒙治疗上长期存在的黑框警语，尤其是关于心血管风险、乳腺癌与失智症的警示，并认定这些警示加剧了恐惧和错误讯息的蔓延。去年，约有3200万张雌二醇处方，较2021年的1800万张上升，据报从2024年到2025年上升约32%。在2002年《Women's Health Initiative》研究长期推动保守的背景下，Marty Makary主委的公开倡导放大了这次反弹。
目前大部分雌二醇使用在皮肤贴片上，总处方量增加，而口服药锭使用近十年保持相对稳定。需求上升导致供应紧张：美国医院药局协会在1月30日将贴片列为短缺，Jessica Halem也回报CVS多次缺货，在每周、每两周贴片与喷剂之间反复替换。使用雌二醇的女性常搭配夜间服用黄体酮；此类处方从2021年的520万张增至近1400万张。美国更年期学会认为皮肤吸收相较口服更具优势，而临床医师也报告其除潮热外，可改善睡眠中断与关节疼痛。
更广的历史背景显示政策敏感的剧烈波动。首个更年期荷尔蒙疗法于1942年获FDA批准；2001年美国绝经后女性中接近30%使用疗法，但在黑框警语后，2020年降至4.7%。近期Bloomberg数据显示目前仅约7%目标年龄人群在使用，显示尚有大幅成长空间。Viatris、Sandoz与Amneal因此获得63亿美元的营收增益，但供应能力压力在用量上升时同步增加。若监管压力与公共讨论持续，采用率可能进一步扩张；然而由于阴道雌激素改为非处方药需约六个月流程，健康体系仍需更快的生产回应。
Lea Didion, 45, began hormone replacement therapy after menopausal symptoms in her 40s and reported sharp improvement: pain relief, higher energy, better gut comfort. Her case reflects a U.S. shift after the FDA softened long-standing black-box warnings on hormone therapy—especially warnings about cardiovascular risk, breast cancer, and dementia—seeing them as having fueled fear and misinformation. About 32 million estradiol prescriptions were written last year, up from 18 million in 2021, with reports of a 32% rise from 2024 to 2025. After decades of caution influenced by the 2002 Women’s Health Initiative study, commissioner Marty Makary’s public advocacy amplified the rebound.
Most estradiol use is now through patches, while total prescriptions increased and tablet use remained relatively stable over the past decade. Demand growth produced shortages: the American Society of Health-System Pharmacists listed patch shortages on Jan. 30, and Jessica Halem reported repeated CVS stock-outs while switching among weekly, twice-weekly, and unavailable spray formats. Women using estradiol commonly pair it with nightly progesterone pills; those prescriptions rose to nearly 14 million from 5.2 million in 2021. The Menopause Society notes transdermal absorption advantages over oral routes, and clinicians report benefits beyond hot flashes, including reduced sleep disruption and joint pain relief.
A broader historical lens shows strong policy-sensitive swings: the first menopause hormone therapy was approved in 1942; nearly 30% of U.S. postmenopausal women used therapy in 2001, but usage fell to 4.7% by 2020 after black-box warnings. Bloomberg data now puts use at about 7% of the target age group, implying large upside. Generic producers Viatris, Sandoz, and Amneal captured a $6.3 billion windfall, yet concerns are rising that supply may lag as demand increases. Continued regulatory pressure and public discussion could expand uptake further, but public systems may still need faster production responses than the roughly six-month pathway for vaginal estrogen to reach OTC status.