Three More Menopausal Hormone Therapy Products Lose Outdated Boxed Warnings: FDA Approves Label Updates and Says Patch Output Has Doubled in a Year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The updates remove outdated statements about cardiovascular disease, breast cancer, and probable dementia from the boxed warning sections of the three products.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 said removing outdated statements from these boxed warnings marks a major victory for women's health, and that the federal government is changing how it approaches menopause care by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.
Source: GSM · USA (original Chinese edition)
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