At a Glance
- FDA approved labeling updates for six menopausal hormone therapy products
- Boxed warning language on cardiovascular risk, breast cancer, and probable dementia removed
- Changes follow FDA’s comprehensive scientific evidence review
- Regulators continue to stress individualized treatment decisions
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has approved labeling updates for six menopausal hormone therapy (HRT) products, marking a notable shift in how risks associated with these treatments are communicated. The changes remove statements related to cardiovascular disease, breast cancer, and probable dementia from the boxed warning, the agency’s most prominent safety alert.
According to the FDA, the decision follows a comprehensive review of evolving scientific evidence. The agency initiated the labeling reassessment in November 2025 and requested manufacturers to submit revised safety information. A total of 29 pharmaceutical companies responded, with the first approvals now covering products across four major categories of hormone therapy.
“These updates reflect our commitment to ensure drug labels align with the best available science,” said Robert F. Kennedy Jr., Secretary of Health and Human Services. He emphasized that regulatory guidance must evolve alongside emerging data to support informed decision-making.
The approved labeling revisions apply to therapies representing key treatment approaches for menopausal women, including:
- Systemic combination therapy (estrogen plus progestogen)
- Systemic estrogen-only therapy
- Systemic progestogen therapy used alongside systemic estrogen
- Topical vaginal estrogen therapy
The first set of approved labeling updates applies to six widely used menopausal hormone therapy products spanning multiple treatment categories. These include Prometrium (micronized progesterone) representing progestogen-alone therapy; Divigel (estradiol gel), Cenestin (synthetic conjugated estrogens), and Enjuvia (synthetic conjugated estrogens) representing systemic estrogen-alone therapies; Estring (estradiol vaginal ring) representing topical vaginal estrogen therapy; and Bijuva (estradiol and progesterone capsules) representing systemic combination hormone therapy. The FDA noted that these products were selected to ensure representation across major hormone therapy approaches used in menopausal care.
FDA Commissioner Marty Makary noted that the action aims to provide women with clearer, evidence-based information about hormone therapy. He highlighted that menopause-related symptoms can persist for years and significantly impact daily functioning and quality of life.
Menopause is a natural biological transition, but symptoms can be disruptive. Common concerns include vasomotor symptoms such as hot flashes and night sweats, genitourinary changes linked to declining estrogen levels, and increased risk of osteoporosis. Hormone therapy remains an FDA-approved option for managing moderate-to-severe hot flashes, vaginal dryness, and preventing bone loss.
The agency also pointed to data from randomized studies suggesting that women who begin hormone therapy within ten years of menopause onset, typically before age 60, may experience reductions in fracture risk and overall mortality. Despite this, hormone therapy use remains relatively low.
FDA estimates indicate that while tens of millions of U.S. women fall within the typical menopausal age range, only a small fraction receive hormone therapy prescriptions. Experts suggest that earlier safety concerns, clinical hesitations, and misinterpretation of risk data have contributed to underutilization.
Regulators emphasize that hormone therapy decisions should be guided by individual patient factors. Women are encouraged to review the updated prescribing information and consult their healthcare professionals to better understand the benefits and risks associated with these therapies.
Reference
FDA Approves Labeling Changes to Menopausal Hormone Therapy Products, 12 February 2026, https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products
Menopausal Hormone Therapies with Updated Prescribing Information, 12 February 2026, https://www.fda.gov/drugs/drug-safety-and-availability/menopausal-hormone-therapies-updated-prescribing-information
