FDA Removes Black Boxed Warning From Hormone Therapies for Menopause

The FDA is removing the black box warning from hormone replacement therapies (HRTs) for menopause. The decision follows a comprehensive scientific review and represents the first major reassessment of HRT safety in more than 2 decades.

The FDA’s updated labeling will remove references to increased risks of cardiovascular disease, breast cancer, and probable dementia. However, the warning for endometrial cancer will remain on systemic estrogen-alone therapies.¹

The announcement was made by Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, MD, MPH, at a press conference.¹

“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” said Kennedy. “For more than 2 decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”¹

“Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk,” said Makary. “For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.”¹

HRT is commonly prescribed to relieve menopause-related symptoms, such as hot flashes, vaginal dryness, and mood changes, that occur as estrogen levels naturally decline with age. There are 2 primary forms of HRT: estrogen-only therapy, generally used for those without a uterus, and combined estrogen-progestin therapy, which is prescribed when the uterus remains intact to lower the risk of endometrial cancer.²

However, their use fell sharply in the early 2000s following potential risks for breast cancer, cardiovascular disease, and dementia. Those warnings stemmed from the Women’s Health Initiative (WHI) study, which reported a slight, statistically non-significant increase in breast cancer risk among participants. The study has since been widely criticized for its design, as most participants were over age 60, beyond the average age of menopause, and given hormone formulations no longer in standard use.¹

Despite the findings of the WHI study, various randomized studies indicate that women who begin HRT within 10 years of menopause onset, or before age 60, experience significant health benefits, including reduced all-cause mortality, lower rates of fractures, and decreased risks of cardiovascular disease and Alzheimer’s disease.¹

The FDA’s decision also coincides with new approvals aimed at broadening access to menopause care. The agency approved the first generic version of Premarin (conjugated estrogens; Pfizer Inc) in over 30 years. Additionally, a new non-hormonal therapy for moderate to severe vasomotor symptoms has been approved for women who cannot or prefer not to use HRT.¹

REFERENCES

1. HHS advances women’s health, removes misleading FDA warnings on hormone replacement therapy. FDA. November 10, 2025. Accessed November 10, 2025. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy-0

2. Gerlach A. Study Links Specific Hormone Therapies to Breast Cancer Risk in Younger Women. Pharmacy Times. July 2, 2025. Accessed November 10, 2025. https://www.pharmacytimes.com/view/study-links-specific-hormone-therapies-to-breast-cancer-risk-in-younger-women