FDA Removes Hormone Therapy Warnings — What Women Need to Know Now

Hi friends,

A major shift just happened in women’s health — something that will reshape how millions of women approach menopause, bone density, and long-term wellness.

For the first time in over 20 years, the FDA has removed the old “black box” warnings from most menopausal hormone therapy products.

This move reflects what the science has shown for years:

✔ Hormone therapy is safe for most women

✔ Starting earlier (before 60 or within 10 years of menopause) has the best safety profile

✔ Benefits include symptom relief, bone protection, cognitive health, and metabolic support

✔ Breast cancer risk has been dramatically misunderstood and overstated

And now the FDA is officially correcting the misunderstanding.

Why this matters

Back in 2002, results from the Women’s Health Initiative were misinterpreted, misreported, and generalized to all women of all ages.
Many clinicians stopped prescribing hormone therapy, and millions of women suffered needlessly.

We now know:

  • The WHI enrolled women in their 60s and 70s, long past the ideal window.

  • Risks reported were inflated by age and health status.

  • Later analyses show dramatically safer profiles for women starting earlier.

So the FDA removed the broad warning and replaced it with modern, nuanced guidance.

What is the NEW guidance?

⭐ The safest and most effective time to start hormone therapy is:

Before age 60, or within 10 years of menopause onset.

This includes perimenopause — even if you’re still having irregular periods.

Women who begin in this window see:

  • Strong reduction in hot flashes

  • Better sleep

  • Clearer thinking

  • Improved metabolic function

  • Better mood stability

  • Reduced anxiety

  • Protection of bone density

  • Improved cardiovascular function

This is why hormone optimization is becoming a central pillar of modern longevity medicine.

But what about breast cancer?

This is the #1 misconception — and the source of unnecessary fear.

Here’s what the updated analysis shows:

✔ Estrogen alone lowers breast cancer risk.

(Women who’ve had a hysterectomy fall into this category.)

✔ Estrogen + progesterone shows a very small increased risk, but only after 5–7+ years.

And the type of progesterone matters:

  • Synthetic progestins = slightly higher risk

  • Micronized progesterone (bioidentical) = lowest risk profile

✔ Starting early (before 60) keeps risk the lowest.

The FDA removed the boxed warning because the science simply does not support the sweeping fears caused by early WHI interpretation.

Types of therapy that are now preferred

1. Transdermal estrogen (patch or gel)

  • Best cardiovascular safety

  • Lowest clotting risk

  • Very stable absorption

2. Micronized progesterone

  • Improves sleep

  • Most natural profile

  • Safest long-term data

3. Local vaginal estrogen

  • Extremely low systemic absorption

  • Zero increased cancer or clot risk

  • First line for dryness or pain

Monitoring: what modern care looks like

Before starting

  • Symptoms review

  • Blood pressure

  • Thyroid, CMP, CBC

  • Lipid panel

  • Uterine history

  • Baseline bone scan (REMS or DEXA)

3–6 months after starting

  • Symptom review

  • Dose fine-tuning

  • Optional bloodwork

  • Sleep, mood, weight, energy assessment

Annually

  • Breast screening

  • Dose review

  • Repeat bone density (every 1–2 years)

No automatic stop date.
No age at which hormones suddenly become unsafe.

Modern guidelines (NAMS, ACOG, Endocrine Society) say:

❝

Continue therapy as long as benefits outweigh risks.

Why this matters for bone health

Women lose up to 20% of their lifetime bone density in the 3–5 years surrounding menopause.

Hormone therapy is one of the most powerful tools to:

  • Slow bone loss

  • Improve bone remodeling

  • Support osteogenic response to OsteoStrong sessions

It fills in the hormonal foundation that many women don’t realize they’re missing.

What this means for YOU

If you’re experiencing:

  • Hot flashes

  • Mood changes

  • Poor sleep

  • Weight gain

  • Anxiety

  • Low libido

  • Brain fog

  • Perimenopausal irregular cycles

— NOW is the ideal time to get evaluated, not years later.

We can help with:

  • Full bone density testing

  • Functional medicine consults

  • Longevity programs

  • Women’s hormonal health education

  • Personalized supplement and lifestyle guidance

If you want help figuring out where you are in the transition or what your next step should be, reply to this email and we’ll guide you.

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