Hormone Therapy Finally Gets Its Due – From the FDA Itself

And local women have more choices than ever

by Dr. Gustav Lo 

For more than 20 years, hormone replacement therapy (HRT) has sparked fear, debate, and confusion for women navigating menopause. But big changes are happening: in November 2025, the FDA announced the removal of its strictest warnings about HRT for women – a major shift that’s bringing new hope and reassurance to midlife women across Central Florida. 

In a press conference, the head of the FDA, Dr. Marty Makary, summed it up:

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

What did he mean?

Dr. Makary first points out that clinical studies have confirmed hormone replacement therapy does not increase breast cancer risk. But even more importantly, the FDA now emphasizes the fact that HRT can dramatically reduce a woman’s chances of heart attacks, strokes, fractures, and even Alzheimer’s disease. 

Quality of life matters too. Many of my patients describe soft benefits that are just as meaningful as the big reduction in health risks: better sleep, more stable moods, clearer thinking, improved libido, and renewed energy. These daily changes are something we can see and feel and celebrate every day – and they reflect true physiological benefits that many women have been prevented from experiencing.

For years, national misunderstandings blocked women from getting effective care. The misinterpretation of the Women’s Health Initiative study in the early 2000s created a cycle of alarm – doctors were afraid to treat menopause and medical schools and residencies stopped teaching it, which shut women out of almost any effective care. This led to a real decline in women’s health overall. When you consider the downstream effects of hormone deficiency – heart attacks, strokes, broken hips, Alzheimer’s – menopause itself emerges as a leading cause of premature death in women. In his editorial, Dr. Makary rightly suggests HRT may be more important in preventing heart attacks and strokes than cholesterol drugs. Hormone replacement is, quite literally, preventive medicine. 

Now, the FDA is setting the record straight:

• The "black box" warnings about breast cancer are being removed for estrogen. 

• Heart, bone, and brain health are protected by HRT, with risk reductions up to 50-60% for serious concerns like fractures, heart attacks, and strokes. 

• Some warnings remain for certain risks (for example, endometrial cancer for estrogen-alone therapy in women with a uterus), reflecting the importance of personalized, expert-guided care. 

As happy as we all should be with this dramatic policy shift at the FDA, it doesn’t instantly make every physician a menopause expert or change their care plan. Most primary care doctors and OB-GYNs trained in the last 20 years have discouraged hormone replacement their whole careers, and they won’t change overnight. But there have been positive changes in the last 20 years, too: menopause medicine has developed as a specialty, and there are now Menopause Society Certified Providers (in Central Florida and nationwide) who are well-educated and experienced in providing hormonal and non-hormonal treatments before, during, and after menopause.

For many women, this announcement is both vindication and invitation: an acknowledgment that choosing hormone therapy was the right call – and a signal that it’s time for others to take a second look. Menopause is not just a life stage; it’s a modifiable medical condition. We hope this FDA statement is the start of a real public health campaign to encourage women to protect their hearts, bones, and brains – and maybe even feel normal again.

Gustav Lo, MD, is the Chief Medical Officer of RegenCen,  a regenerative and anti-aging medical clinic specializing in hormone replacement and longevity medicine. RegenCen is a Menopause Society Certified Practitioner and has multiple locations in Florida, including Lake Mary and Winter Park.