FDA removes boxed warnings from 3 more menopausal hormone therapy products

The FDA has approved updated labeling for 3 additional menopausal hormone therapy (MHT) products, removing statements on cardiovascular disease, breast cancer, and probable dementia from their boxed warnings, according to an October 30, 2026, release from the US Department of Health and Human Services (HHS). All 3 products are estradiol transdermal patches from 2 applicants, though the FDA did not provide details on brand or manufacturer names.¹

The approvals follow the agency’s February 2026 action on labels for 6 MHT products. The FDA began engaging companies on the changes in November 2025, and 29 drug companies have submitted proposed labeling changes to date, the agency stated. HHS added that the latest actions support the executive order “Advancing Women’s Health to Improve Outcomes in All Phases of Life,” signed October 19, 2026.^1,2

According to a report from The Guardian, the FDA did not hold an advisory committee meeting and provided limited details on its reasoning in a press briefing.³

“I am glad to see the lifting of black box warnings on these transdermal estrogen products,” Susan Reed, MD, MPH, MS, Professor Emeritus, Department of Obstetrics and Gynecology, UW Medicine, told Contemporary OB/GYN.

“The pendulum has swung from the far left to the far right. We need to carefully consider additional questions as the block box warnings continue to be lifted, finding the right balance for the safety of all women, particularly those with a uterus,” she said.

Reed added that, as boxed warnings are removed, some questions to consider include, “Are these products safe when started over ages 60-65?” and “Should there be a mention of risks when transdermal estrogens are taken with oral progestogens?”

Additionally, for clinicians who will now counsel patients on treatments that do not contain a boxed warning, Reed said open and clear communication is crucial.

“Careful shared decision-making is even more important than before,” she said. “Removal of the black box warnings makes it the clinician’s responsibility to understand risks for special populations based on the baseline cardiovascular and breast cancer risks, and based on their age.”

Patch availability and reported patient struggles

The labeling updates come as reports continue to highlight struggles among HRT patients regarding availability of patches for symptom burden.⁴ In September, the FDA acknowledged these struggles but did not call the situation a shortage^.5

“The Agency is in close contact with manufacturers of all FDA-approved MHT formulations and, based on current information, is not aware of an imminent risk of a nationwide shortage,” the FDA again stated in the October 30, 2026 announcement.¹

“In addition, FDA continues engaging with all six manufacturers of FDA-approved estradiol transdermal patches to address access challenges driven by a significant rise in demand. Manufacturers have and continue to actively scale up, with measures including expanded production capacity, additional manufacturing shifts, and prioritized output of estradiol patch products. These efforts have resulted in an overall doubling of market output in the last 12 months. Patches are only one option for treatment, and FDA continues to monitor supply for other dosage forms, such as gels and creams.”

Which products were updated in February?

The first 6 products spanned 4 categories of hormone therapy for menopausal women:

• progesterone capsules (Prometrium), a progestogen alone
• estradiol gel (Divigel), synthetic conjugated estrogens A tablets (Cenestin), and synthetic conjugated estrogens B tablets (Enjuvia), each a systemic estrogen alone
• the estradiol vaginal system (Estring), a topical vaginal estrogen
• estradiol and progesterone capsules (Bijuva), a combined systemic estrogen and progestogen

At the time, the FDA noted that multiple hormone therapies are approved for moderate to severe hot flashes, vaginal dryness and discomfort, and bone loss prevention. Of approximately 41 million US women aged 45 to 64 years in 2020, however, approximately 2 million received a hormone therapy prescription.²

Generic approvals and over-the-counter vaginal estrogen

The FDA is also approving generic MHT products and exploring over-the-counter availability of vaginal estrogen products. Any switch of those products from prescription status would require FDA approval.¹

References:

1. Trump Administration delivers for women with major advances in menopause care. News release. US Department of Health and Human Services. October 30, 2026. Accessed October 30, 2026. https://www.hhs.gov/press-room/fda-advances-menopause-care-hormone-therapy-labeling-access.html
2. FDA updates labels on multiple menopausal hormone therapies. Contemporary OB-GYN. February 12, 2026. Accessed October 30, 2026. https://www.contemporaryobgyn.net/view/fda-updates-labels-on-multiple-menopausal-hormone-therapies
3. Schreiber M. FDA again bypasses advisers to remove black-box warnings from menopause treatments. The Guardian. Published October 30, 2026. Accessed October 30, 2026. https://www.theguardian.com/us-news/2026/oct/30/fda-remove-warnings-menopause-treatments
4. US health department to remove broad black box warning from three estrogen patch products. Reuters. Published October 30, 2026. Accessed October 30, 2026. https://www.reuters.com/legal/litigation/us-health-department-remove-broad-black-box-warning-three-estrogen-patch-2026-10-30/
5. Fitch J. FDA working with manufacturers to increase access to estradiol transdermal patches. Contemporary OB/GYN. Published September 4, 2026. Accessed October 30, 2026. https://www.contemporaryobgyn.net/view/fda-working-manufacturers-increase-estradiol-transdermal-patches