Is Hormone Therapy Safe? FDA Removes Black Box Warning on HRT

Menopause is a natural transition, but that does not mean it is easy. In my practice, I regularly sit with women who are exhausted from night sweats, struggling with anxiety they have never experienced before, frustrated by weight changes, low libido, poor sleep, and brain fog. And almost without fail, the next sentence I hear is, “I am scared of hormone therapy.”

That fear traces back to the 2002 Women’s Health Initiative study.¹ The initial reporting suggested that hormone therapy dramatically increased the risk of breast cancer, heart disease, and stroke. What many people do not realize is that the study primarily involved women with an average age of 63 who were well past menopause and used specific oral formulations that are not the most commonly prescribed options today.

Subsequent reanalysis has shown that age, timing, formulation, and route of administration matter tremendously.² For women who are newly menopausal or within ten years of menopause onset, the benefit to risk profile looks very different than what was portrayed in early headlines.

Unfortunately, the damage was done. Patients were frightened. Physicians became hesitant. And decades later, I am still helping women untangle misinformation.

Hormone Therapy Can Be Life Changing

For many woman, hormone therapy including estrogen with appropriate progesterone support can dramatically improve quality of life. When thoughtfully prescribed, hormone therapy can support sleep, stabilize mood, reduce vasomotor symptoms, protect bone density, and improve overall vitality.³

In my clinical experience, I have seen women reclaim their energy, their confidence, and their sense of self with carefully individualized hormone therapy. That does not mean it is for everyone. It means it deserves an informed, personalized conversation.

My approach is always grounded in the lowest effective dose for your individual body. We assess your symptoms, your health history, your risk factors, and your goals. We monitor closely. We adjust when needed. Hormone therapy is never about excess. It is about restoring balance.

A More Informed Conversation

For years, many of us have been practicing in the shadow of fear created by early interpretations of the 2002 data. That is why the recent announcement from the U.S. Department of Health and Human Services feels so significant. In November 2025, HHS shared that the FDA is initiating the removal of the broad boxed warnings that were placed on hormone replacement therapy after the original Women’s Health Initiative publication.⁴

After a comprehensive review of the scientific literature, input from an expert panel, and a public comment period, the FDA concluded that those sweeping warnings overstated risk for many women, especially those who begin hormone therapy within ten years of menopause or before age sixty. Updated labeling will remove references to cardiovascular disease, breast cancer, and probable dementia

for appropriate candidates, while retaining the boxed warning for endometrial cancer with systemic estrogen alone in women who have a uterus.

To me, this represents a return to thoughtful, evidence based medicine. It acknowledges that the original study population was older and used formulations that are no longer common, and it reinforces what we now understand more clearly: timing matters, formulation matters, and individualized care matters. Most importantly, it opens the door for women and their physicians to make decisions based on current science rather than lingering fear.

If you are suffering through menopause because you are afraid of hormones, I encourage you to revisit the conversation. You deserve evidence informed guidance, not outdated fear.

If you would like support navigating menopause, I invite you to schedule a personalized consultation so we can explore all of your options, including lifestyle, nutrition, botanical support, and when appropriate, hormone therapy tailored to you.

Schedule Now!

References

1. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA. 2002;288(3):321-333.

2. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended follow up of the Women’s Health Initiative randomized trials. JAMA. 2013;310(13):1353-1368.

3. The North American Menopause Society. The 2022 hormone therapy position statement of The North American Menopause Society. Menopause. 2022;29(7):767-794.

4. U.S. Department of Health and Human Services. HHS advances women’s health, removes misleading FDA warnings on hormone replacement therapy. Published November 10, 2025. Accessed February 19, 2026. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy

Hormone therapy is not the villain it was made out to be. For many women, the right dose at the right time can be life changing. If you are navigating menopause and feeling unsure, you deserve a thoughtful, evidence informed conversation. Let’s talk.