Finally, Good news about Hormones

On November 10, 2025, the Food and Drug Administration (FDA), via the Department of Health & Human Services (HHS), announced that they are initiating the removal of the “black-box” warnings from many hormone replacement therapy (HRT) products used to treat menopausal symptoms.

These black-box warnings had been the most stringent warning label the FDA typically places, and they signaled serious risks (e.g., breast cancer, cardiovascular disease, dementia) associated with HRT.

Background

• The original warnings stemmed largely from the early 2000s, when the Women’s Health Initiative (WHI) study reported higher risks of breast cancer, heart disease, stroke, and other outcomes in women taking a very specific combinations of hormones (Conjugated Equine Estrogen/Premarin and Medroxyprogesterone/Provera). This led to a dramatic drop in HRT use.

• Over time, additional analyses, newer trials, and more nuanced understanding (e.g., about timing of initiation, formulation, dose, route of administration) have suggested that the risks may have been overstated or misapplied for many women — particularly for those who start therapy earlier (within 10 years of menopause) or are otherwise good candidates.

What the FDA is saying now

• The FDA’s fact sheet explains that, for standard menopausal hormone therapies (estrogen ± progesterone), when started within the recommended window (generally within 10 years of menopause onset or before age 60), the benefits may outweigh risks for many women.

• Therefore, the FDA is requesting that manufacturers revise labels to remove references to risks of cardiovascular disease, breast cancer, and probable dementia for many products. However:

  • The boxed warning for endometrial cancer with systemic estrogen-alone treatments (in women who still have a uterus) will remain. So balance that estrogen with Progesterone not medroxyprogesterone/Provera!

  • The agency emphasizes that some risks remain and that decisions should be individualized with a clinician.

This regulatory shift is significant for several reasons:

• Access & stigma: For many years, the black-box label acted as a deterrent — many women and clinicians avoided HRT even when symptoms were severe (hot flashes, night sweats, genitourinary syndrome of menopause, etc.). The label change may reduce that barrier.

• Shared decision-making: The emphasis is shifting more strongly toward individualized assessment (age, health status, risk factors, time since menopause onset, formulation/route) rather than blanket avoidance. Compounded HRT can provide even more individualized dosages!

• Potential broader health benefits: Some studies suggest that timely HRT may have benefits beyond symptomatic relief — such as bone health (fracture prevention), and possibly cardiovascular or cognitive benefits in selected populations.

For many women, menopause is not just a minor transition — it can bring serious symptomatic burden (hot flashes, night sweats, vaginal/urinary changes, mood/sleep disruptions) and longer-term health implications (bone health, cardiovascular changes, cognitive health). The previous black box warnings may have cast a long shadow, limiting access to therapies that could help.

This regulatory move marks a turning point: one where fear is giving way to more nuanced, evidence-informed conversations. Women and their clinicians still need to make thoughtful, personalized decisions. And as more data accumulates, the hope is that more women will be able to access safe, effective therapies at the right time.

•  (hhs.gov)

•  (wbal.com)

• (medscape.com)