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By Dr. Marguerite Weston |

The FDA & HRT Warnings 2025

What Rolling Back Treatment Risks Means For Menopause Patients

The FDA & HRT Warnings 2025

The Food and Drug Administration (FDA) recently initiated multiple changes to many hormone replacement therapy (HRT) products. This includes the removal of warnings regarding cardiovascular disease, breast cancer and probable dementia. The latest guidance also suggests women begin treatment within 10 years of menopause.

These Changes Are Based On Updated Science & Improved Therapeutic Outcomes

Original HRT warnings were rooted in findings from a Women’s Health Initiative (WHI) study from 2002. This study monitored women with the average of 63 who used hormone formulations that are different than what are commonly used today. This shift in regulatory language reflects updated scientific findings and renewed perspectives on age, risk timing and treatment outcomes.

Here is what we are telling our patients about the FDA & HRT warnings.

The 10-Year Window: Starting HRT Earlier For Greater Results

One of the most significant updates from the FDA is the guidance that systemic HRT may be most beneficial when started within 10 years of menopause or before the age of 60. This updated stance aligns with what we’ve long observed at our practice: when treatment is implemented during this therapeutic window, outcomes tend to be more favorable and risks are lower.

We’ve seen substantial improvements in symptoms such as hot flashes, sleep disturbances, brain fog and mood irregularities among our menopause and perimenopause patients.

“Women between 40 & 60 experiencing perimenopause & the beginning stages of menopause are the biggest winners here. Stigma surrounding hormone therapy was already dropping, but this move makes relief feel more attainable for so many patients. The labeling changes do not mean ‘HRT for everyone.’ But rather, ‘HRT for those who will benefit, after proper screening.'”

What Hormone Therapies & Medications Are Affected

The FDA’s adjustment primarily impacts systemic estrogen therapies, including:

  • Estrogen-only products
  • Estrogen plus progestogen products
  • Localized estrogen therapies used for genitourinary symptoms of menopause
  • Bioidentical hormone combinations
  • Transdermal patches, gels and low-dose vaginal creams

While some risks are being de-emphasized for certain age groups, other warnings (such as those related to endometrial health) remain firmly in place.

How Specialists Proactively Mitigate Each HRT Risk

Credentialed hormone therapy specialists are well aware of the warnings and potential risks associated with HRT. They are equipped to address these concerns both as medical experts and as trusted advocates who understand the real-life impact of menopause.

HRT’s historical black box warning for cardiovascular risk has evolved with new findings showing that age and timing play a significant role. Specialists now focus on optimizing treatment during the “window of opportunity,” typically within 10 years of menopause onset, where one analysis found that women who begin HRT before age 60 have up to a 50% reduction in cardiovascular events and 30–60% reductions in fractures and Alzheimer’s disease risk compared to those not on HRT.

Personalized screening, dosing and regular heart-health evaluations are standard among functional medicine providers.

The estrogen‑only arm of the WHI study observed a reduction in breast cancer incidence in women who had undergone hysterectomy. However, the preparation used was conjugated equine estrogen (CEE), which may behave more like a selective estrogen receptor modulator (SERM) than the estradiol formulations in common use today. All estrogens are not created equally, and more research is needed on the formulations, doses and delivery methods currently in clinical use.  

HRT specialists carefully consider a patient’s personal and family history, choosing hormone types and delivery methods that align with that risk profile. Regular imaging and symptom tracking also further reduce the chance of overlooking complications.

Although HRT was once thought to heighten the risk of cognitive decline in older patients, studies now show that earlier initiation may support brain health. Functional providers integrate cognitive assessments and discuss lifestyle factors that intersect with hormone health.

The goal is to support long-term cognitive resilience, not just symptom relief.

Which HRT Warnings Will Remain On Labels?

The FDA is not removing the boxed warning about endometrial cancer risk for estrogen-only therapy used in women with a uterus. Unopposed estrogen can stimulate the uterine lining and lead to endometrial hyperplasia or cancer, so this warning serves as a prominent caution for women who have not had a hysterectomy.

“During my training, I saw the pendulum swing from HRT being a common treatment to being demonized. We must be careful not to allow it to swing the other way completely, assuming it is beneficial & safe for all. There are some risks with HRT, along with many unknowns, especially in the aspect of timing.”

How Providers Bolster Uterine Safety

In practice, endometrial cancer risk is well-mitigated by adding a progestogen to any estrogen therapy in women who still have a uterus – a fact the label will highlight for prescribers. All other safety information (such as possible blood clots, etc.) will still be described in the detailed package insert.

Many Care Providers Welcome These Historic Changes

The FDA’s label change is being greeted as a positive course-correction by many in the medical community after more than two decades of caution. By eliminating overly broad warnings about serious outcomes, doctors and patients can now engage in shared decision-making with less fear, discussing menopause treatment options on a more level field with more updated science to back up important claims.

Potential Changes In Prescribing Practices

In the early 2000s, doctors were advised to prescribe the lowest HRT dose for the shortest duration possible, out of an abundance of caution. The FDA is now removing that blanket recommendation from the labeling, emphasizing that treatment should be individualized rather than arbitrarily time-limited.

This means patients and providers can decide on the appropriate dose and length of therapy based on personal needs and health factors, rather than a rigid “shortest duration” rule.

“Every woman’s situation is different. That is why we don’t deal in one-size-fits-all plans or rushed appointments. Patients should be given the known risks & benefits as well as the unknowns around treatment. That is true informed consent!”

We Will Continue to Explain All Risks & Warnings to Our Patients

Transparency is the foundation of our hormone therapy approach. At Donaldson, we often consider HRT as an effective intervention for a variety of patients. We also remain dedicated to educating our patients on every risk, benefit and evidence-based alternative available.

Proactive Care Is More Important Now Than Ever

As national warnings shift, some patients may be left without the full context they need to make informed decisions about their health. This makes proactive, personalized care critical. A credentialed HRT provider takes extra steps to ensure you understand what HRT is designed to do, what it may do under less-than-ideal circumstances and how they actively mitigate those risks from day one.

“If a certain risk does apply in your case, we will be upfront about how that factors into our approach & what alternative strategies might be better for you. If a risk is minimal or has been disproven for someone in your profile, we’ll clarify that too, so you’re not avoiding treatment due to misinformation.”

About The Author

Marguerite Weston, MD, IFMCP, is a functional medicine doctor and HRT specialist based in Columbus, Ohio. She leads with an education-first approach, taking time to ensure patients fully understand their treatment options. Her goal is to improve the daily lives of her patients and to empower individuals everywhere to feel confident and autonomous in their health decisions.

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