The Truth Is Out: HRT Is Safe and Gives Women Their Quality of Life Back

In November 2025, a historic turning point occurred: the U.S. Food and Drug Administration (FDA) removed the so-called boxed warning — its strictest safety warning — from hormone replacement therapy (HRT). After more than twenty years, the agency officially acknowledged that past fears surrounding HRT were based on misinterpreted data, and that hormone therapy for menopausal women is, when used appropriately, safe and beneficial.

“This is a huge shift that corrects one of the biggest medical injustices against women,” says Miro Skořepa, Longevity Architect and founder of Zenith Swiss Longevity Clinic in Prague. “For years, women were afraid of something that could have dramatically improved their quality of life. Now it is finally confirmed that hormone therapy has its rightful place — and the fear was unnecessary.”

What Has Actually Changed for Women?

The original FDA warning from 2002 followed the publication of the Women’s Health Initiative (WHI) study, which suggested increased risks of breast cancer and thrombosis with HRT use. Today we know that these results were misinterpreted. The data did not distinguish between age groups, health status, or timing of therapy.

Yet the average age of women in the study was 63, and most were long past the natural menopausal transition. Only 10% of participants were aged 50–54 — the age when HRT is typically most appropriate. Post-hoc analyses (2007, 2013) later clarified the timing hypothesis: the benefits and risks of HRT differ significantly between women under 60 and women over 70.

Specifically:

• In women 40–59, HRT did not increase nor decrease cardiovascular risk.

• In women over 70, the risk was higher.

  
  

Headlines at the time warned of a 25% increase in breast cancer, but the actual figure was 8 cases per 10,000 women per year — just 0.08%. Moreover, women without a uterus actually experienced reduced breast cancer risk, a conclusion firmly supported by WHI.

Modern research now confirms that initiating HRT early, during perimenopause, offers far more benefits than risks — from reducing hot flashes, sleep disturbances, and mood changes to protecting the heart, bones, and brain.

“The goal is for a 50-year-old woman to feel stronger, healthier, and more vital. Menopause can be a reset — and now we have the right medical tools to make that possible,” emphasises Miro Skořepa.
Chief Medical Officer MUDr. Michal Konštacký, PhD, MBA, adds:
“There is no universal approach. Each woman experiences menopause differently. Our Nexus diagnostic system allows us to identify the exact phase of hormonal changes and personalise treatment, nutrition, and exercise so that she feels strong and healthy.”

And the hormones used for HRT today are not the same as those used twenty years ago.
“In the WHI study, hormone preparations were very different from today’s modern bioidentical and transdermal forms, which have a much better safety profile according to current data,” explains MUDr. Konštacký.

Why Diagnostics Matter Today

Menopause does not arrive suddenly. The body transitions toward it gradually — sometimes starting in the early forties. Most women, however, have no idea which phase they are in and rely only on symptoms, which may be misleading.

That is where diagnostics are essential. They make it possible to:

1) Identify the true phase of hormonal transition

Cycles may still appear regular, yet hormones may already be fluctuating. Biomarkers, genetic predispositions, and wearable-device data provide an accurate picture — not just a subjective impression.

2) Understand how fast a woman is biologically ageing

This is crucial, because menopause significantly affects metabolism, muscles, bones, sleep, and the brain. Diagnostics reveal what needs attention first.

3) Tailor treatment to the body — not to standardised charts

Every woman is different: one may need estrogen balancing, another sleep support, inflammation management, insulin control, microbiome care, or stress reduction. Personalised medicine adjusts HRT and non-hormonal support based on real data.

4) Prevent problems that may appear years later

Diagnostics uncover risks that aren’t yet visible on the surface:

• predisposition to bone loss

• development of insulin resistance

• reduced heart rate variability

• decline in muscle strength

• chronic inflammation

These factors affect health in a woman’s fifties — but decide the quality of life in her seventies.

A Shift That Arrived Just in Time

The FDA’s decision represents a major transformation in women’s health — not only in the United States, but globally. It removes long-standing stigma around hormone therapy and gives physicians more room for individualised care.

According to the WHO, by 2030 more than 1.2 billion women worldwide will be in menopause or postmenopause. This shift in perspective on HRT therefore comes at the perfect moment. For the first time, menopause can be seen not as an ending, but as the beginning of a new phase of life — one that can be healthier, more energetic, and more vital than the years before it.

Modern longevity medicine offers women the tools to make this a reality.

“Menopause is not the end — it is an opportunity. When a woman understands her body, uses modern medicine, and complements it with proper nutrition, sleep, and movement, she can feel better than ever before,” concludes Miro Skořepa.

The FDA’s decision not only corrects an old mistake — it opens the door to a completely new way of caring for the female body. Menopause no longer needs to be something to “get through”, but can become a turning point toward better understanding of one’s own health. Modern diagnostics, personalised medicine, and safely managed hormone therapy allow women to take control of how they age — and, above all, in what condition they will enter the coming decades.