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Warnings Removed on Hormone Replacement Therapy

Hormonal therapy can have a tremendous impact on the quality of life for women!

 In the Summer of 2025, the Food and Drug Administration (FDA) gathered a panel to evaluate the risks and benefits of hormone replacement therapy (HRT) for women. Following the expert recommendations, the FDA announced in November 2025 that it would no longer mandate companies to include a “black box warning” regarding the risks of cardiovascular disease, breast cancer, and dementia.

The warnings were placed on hormone replacement products in 2003 due to early findings of a large study (Women’s Health Initiative) that suggested significant health risks. The results of the Women’s Health Initiative (WHI) study were generalized to all women, despite the fact that its participants were older and using older oral hormone types. Subsequent re-analysis revealed that for women under 60, who are within ten years of menopause, the risks associated with HRT are considerably lower. Additionally, newer, lower-dose hormonal treatments present different risk profiles compared to the older medications assessed in the WHI study (reference).

Most expert groups recommend hormonal medications as the first-line treatment for younger women experiencing moderate to severe menopausal symptoms, unless contraindicated (reference). The balance of risks and benefits appears to shift significantly with age, leading the American Geriatric Society to advise against starting hormonal replacement therapy for women aged 65 and older.

All medications have benefits and risks. The relative risks and benefits differ for each person and each individual should discuss these risks with their primary care provider. For instance, a person with a history of a cancer that could be exacerbated by HRT will face greater risks compared to someone without such a history.

The method of delivery and specific hormones utilized can also influence the risk-benefit balance. For example, hormone patches present a lower risk for blood clots than pills, likely due to the metabolic processes that occur in the liver. When substances are absorbed through the gut, they first pass through the liver, where estrogens can stimulate clotting factor production. Although patches are generally more expensive than pills, the absolute risk of blood clots for younger women is very low. Therefore for younger women the lower cost and convenience of pills may be a reasonable trade off for a slightly higher risk of blood clots.

We will continue to learn more about the relative risks and benefits of hormone replacement therapy. One area of evolving interest is the role that topical estrogens have on preventing urinary tract infections. Studies are showing that vaginal applied estrogen is an effective treatment for helping postmenopausal women with recurrent urinary tract infections prevent future infections. Topical estrogen is thought to prevent urinary tract infections by restoring vaginal tissue thickness, improving local blood flow, and encouraging healthy Lactobacillus bacteria to block infection-causing uropathogens. (reference)

Low-dose vaginal estrogen medications have minimal impact on systemic estrogen levels, thus carrying fewer risks than pills or patches. These products are often prescribed for conditions like genitourinary syndrome of menopause. Another topical hormonal product approved by the FDA for this condition is prasterone (brand name Intrarosa), which is a form of the hormone DHEA that converts to estrogen and testosterone within vaginal cells. The vaginal tissues are rich in receptors for both hormones, and stimulating these receptors may offer benefits for some women.

For males the FDA is actively pursuing possible changes in the indications and labeling of hormone treatment. In April (2026) the FDA made an announcement encouraging manufacturers of testosterone products to contact the FDA if they are interested in expanding their current very limited FDA approved indications for testosterone replacement therapy.

As we learn more about hormone replacement therapy, I will be sharing this information. In the meantime please check out a couple of my other recent posts:

Higher Protein Diet plus Resistance Training Effects on Fat Loss and Saving Muscle

Updated Guidance for Resistance Training for All of Us

For a list of great resources to learn more about hormone replacement therapy click here.

See here for pelvic floor exercises.

See here for an article on the Food and Drug Administration.

To close out this article, I must honor the life of Dolly Parton. She is special in many ways including how in a country so divided, we all seem to love Dolly Parton. Dolly Parton will be remembered for many things. I hope that she will always be appreciated for how she shared her good fortune with others. A great example is the “Dolly Parton Imagination Library” through which she has placed books in the hands of millions of kids. She said she is as proud of this project as she is of anything she has done in her life. Dolly was also an advocate and contributed to the advancement of science and public health; the science journal Nature honored her with this article.

Thank you Dolly.

2026-2027 Vaccine recommendations for kids and adults.

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