What changed

On Nov 10, 2025, the FDA announced it will remove the “black box” safety warnings from FDA-approved menopausal hormone therapy (MHT/HRT) products (pills, patches, creams). The old boxed warnings, added after early 2000s data, broadly suggested elevated risks for heart attack, stroke, dementia, and breast cancer. FDA now says those risks were overgeneralized and is updating labels to better reflect a nuanced, individualized benefit–risk profile.

Why it matters

  • Access & confidence: Removing the boxed warning is expected to reduce stigma, increase prescribing comfort, and help appropriately symptomatic women access therapy.
  • Timing matters: Labels will emphasize best outcomes when HRT is started within 10 years of menopause onset or before age 60, aligning with contemporary evidence.
  • Right patient, right product: Updates distinguish between systemic and local (vaginal) therapies and stress tailoring dose, route, and duration to the individual.
    JAMA Network
  • Not risk-free: Risk isn’t “zero”—it’s context-dependent (history, age, timing, formulation). Shared decision-making and appropriate screening remain essential.

The bottom line for patients

If you’re struggling with hot flashes, night sweats, sleep disruption, or genitourinary symptoms, today’s decision removes an outdated, one-size-fits-all warning and supports a personalized discussion with your clinician about whether HRT is right for you—what type, what dose, and for how long.

Michelle Keating-Sibel Menopause Practitioner with The North American Menopause Society now known as The Menopause Society. FDA changes black box regulations for HRT
Dr. Michelle Keating-Sibel, DNP, CRNP, FNP-BC, is a board-certified Family Nurse Practitioner and the co-founder of Lumen Aesthetics & Wellness. She specializes in evidence-based care in general wellness, hormone therapy, medical weight management.

Meet Michelle

& learn more about HRT

Why Start in Perimenopause?

Perimenopause is often when symptoms spike—not because hormones only drop, but because they swing. Treating earlier can steady the roller coaster and help you stay ahead of the effects. Large peer reviewed studies, statements and trials support these symptom improvements in women as they near the menopause transition.

Many women notice improvements within weeks, like:

  • Fewer hot flashes/night sweats
  • Better sleep and clearer thinking
  • More even moods
  • More comfortable sex and improved libido
  • More stable daytime energy

Q’s

How fast will I feel better?

Many women notice improvements in hot flashes, sleep, and mood within 4–6 weeks, with continued gains as we fine-tune. (Lippincott Journals)

How long should I stay on HRT?

It’s individualized. Fracture protection and symptom relief last while you’re on therapy; benefits diminish after stopping, so we tailor duration and revisit yearly. (PubMed)

1) Bones: Strength now, protection while on therapy

Estrogen helps maintain bone. In the Women’s Health Initiative and other trials, HRT reduced fractures (including hip and spine) during use across different risk groups. Protection fades after stopping, so we personalize duration and exit plans. (PubMed)

2) Heart & metabolism: the “timing” story

You’ve probably seen mixed headlines. Here’s the evidence-based summary:

  • Starting HRT closer to menopause is associated with more favorable cardiovascular signals. In the ELITE randomized trial, women who began estradiol within 6 years of menopause had slower progression of subclinical atherosclerosis (carotid intima-media thickness) than placebo; this was not seen when starting ≥10 years after menopause. (A surrogate outcome, but biologically meaningful.) (New England Journal of Medicine)
  • At the same time, the USPSTF recommends against using HRT solely to prevent chronic conditions (e.g., heart disease) in postmenopausal persons. We prescribe HRT for symptom relief; any cardiometabolic benefits are considered a possible bonus when started near menopause. (uspreventiveservicestaskforce.org)

3) Brain, sleep, and “feeling like yourself again”

Better sleep and fewer night sweats often unlock daytime focus, mood stability, and productivity. Expert statements consistently note improvements in vasomotor symptoms, sleep, mood, and quality of life with appropriately prescribed HRT. (Lippincott Journals)

Personalization is everything

Your health history, family history, and goals guide the plan. We select route and dose (for example, transdermal estradiol plus micronized progesterone if you have a uterus) with an eye on symptom relief and safety. Professional guidance emphasizes individualized decisions, the lowest effective dose, and regular follow-up. (Lippincott Journals)

Risk varies by regimen and duration. In long-term follow-up of WHI participants, 5–7 years of menopausal hormone therapy was not associated with increased all-cause mortality over 18 years. Your clinician will personalize duration and discuss breast health screening. (JAMA Network)

  1. Listen & assess: We map symptoms, cycle patterns, health history, and goals.
  2. Targeted labs: If necessary, and rule out look-alikes.
  3. Personalized plan: Often transdermal estradiol + oral micronized progesterone when indicated; other options exist and we’ll discuss them.
  4. Follow-through: We review response, adjust dosing, and monitor safety over time.

You’re cared for by experienced nurse practitioners in active family practice, so your hormone care sits inside your bigger health picture—medications, sleep, mood, blood pressure, and life.

We don’t prescribe HRT solely for prevention. There’s evidence that earlier initiation has more favorable cardiovascular signals, but guideline bodies still recommend HRT primarily for symptom relief. (New England Journal of Medicine)

Ready to feel more like you again?

If perimenopause is disrupting your days (and nights), you don’t have to wait. Book a consultation to see if HRT is a good fit—get started.

A mental-health bonus

In a randomized clinical trial, transdermal estradiol plus intermittent micronized progesterone cut the risk of developing clinically significant depressive symptoms during the menopause transition by about half vs placebo over 12 months. (PMC)

References are studies that have been peer-reviewed & guideline sources.

  • The Menopause Society (NAMS) 2022 Position Statement: HRT is the most effective therapy for vasomotor symptoms and GSM; prevents bone loss/fractures; benefit-risk depends on timing, type, dose, route. (Lippincott Journals)
  • USPSTF 2022 Recommendation: Do not use menopausal hormone therapy for primary prevention of chronic conditions in postmenopausal persons. (uspreventiveservicestaskforce.org)
  • ELITE Trial (NEJM 2016): Early (but not late) estradiol initiation slowed progression of subclinical atherosclerosis (CIMT). (New England Journal of Medicine)
  • Fracture Reduction: WHI and other RCTs show reduced fracture risk during active use of HRT. (PubMed)
  • Mood Benefit RCT (JAMA Psychiatry 2018): Transdermal estradiol + intermittent micronized progesterone prevented onset of clinically significant depressive symptoms in perimenopausal/early postmenopausal women. (PMC)
  • WHI 18-Year Follow-Up (JAMA 2017): No increase in long-term all-cause mortality after 5–7 years of MHT vs placebo. (JAMA Network)

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