• On November 10, 2025, HHS and the FDA announced they are removing the broad “black box” safety warnings from most menopausal hormone replacement therapy (HRT) products.

• Labels will no longer highlight increased risks of cardiovascular disease, breast cancer, and dementia in a one-size-fits-all way, though standard risk language and some specific warnings will remain.

• The endometrial cancer boxed warning stays for systemic estrogen-only products in women with a uterus.

• The change is expected to roll out over the next ~6 months as manufacturers update labels.

• This does not mean HRT is risk-free; it means the old warnings overstated risk for many women, especially younger women starting HRT near menopause.

• Women in Queens, Elmhurst, Jackson Heights, Forest Hills, and Flushing should still work with a doctor who uses labs, history, and personalized dosing to decide if HRT is right for them.

The original scare: the Women’s Health Initiative

In the early 2000s, a large study called the Women’s Health Initiative (WHI) looked at older forms of HRT: oral conjugated equine estrogen plus a synthetic progestin called medroxyprogesterone acetate (MPA).

Early headlines claimed:

• More breast cancer

• More stroke

• More heart problems

The FDA responded in 2003 with a boxed warning, its strongest type of safety label. Within a few years, HRT use dropped by more than 70%, and has stayed low.

What the re-analysis showed

Over the last 20+ years, deeper analysis of WHI and newer trials revealed key details:

• The average age in WHI was about 63—well past the usual age of menopause. Many women were more than 10 years post-menopause.

• The increased breast cancer risk was small in absolute terms and was mainly associated with the old progestin (MPA), not estrogen itself.

• A follow-up WHI analysis of estrogen-alone therapy showed lower breast cancer incidence and mortality versus placebo for some women.

• Modern practice often uses transdermal estrogen (patch, gel) and micronized progesterone, which behave differently from the older oral CEE+MPA regimen.

In short, the WHI results were overgeneralized to all women, all ages, and all formulations—and then frozen into a black box warning that didn’t match newer data.

According to the November 10, 2025 press release and follow-up coverage, here’s what’s happening: 

1. Broad black box warnings are being removed

• The FDA is removing the boxed (black box) warning from most estrogen-containing HRT products for menopause.

• The agency called the old wording “misleading” and not aligned with current science. 

2. Specific risk language is being updated

Labels will be revised to:

• Remove highlighted references to increased risks of cardiovascular disease, breast cancer, and probable dementia that were tied to the old WHI regimen.

• Emphasize individual risk–benefit assessment, age, timing of initiation, and route of administration (oral vs patch vs local vaginal). 

3. One black box warning stays

Not everything disappears:

• The boxed warning for endometrial cancer remains for systemic estrogen-alone products in women who still have a uterus. 

This is why most women with a uterus on systemic estrogen still need progesterone or a progestogen to protect the uterine lining.

4. Timeline: labels will change over the next months

• The FDA is working with manufacturers now.

• Experts expect label changes to roll out over roughly six months, though some products may update sooner than others

The removal of black box warnings is not the same as saying “HRT is harmless” or “everyone should be on hormones.”

Key realities that have not changed:

• HRT is still prescription-only.

• Women still need a careful evaluation (history, physical, labs).

• Some women—such as those with certain cancers, clotting disorders, or uncontrolled cardiovascular disease—may not be good candidates.

• Dose, type of estrogen, and progesterone still matter a lot.

• Follow-up and routine monitoring are still essential parts of safe care.

The big shift is this: instead of fear-based, one-size-fits-all warnings, the FDA now wants data-based, nuanced conversations between a woman and her physician.

Breast Cancer

• The increased breast cancer risk seen in WHI was modest and mostly tied to estrogen + MPA, not estrogen alone. 

• Later WHI data found lower breast cancer incidence and mortality in women on estrogen-only compared with placebo over long-term follow-up.

• Modern regimens more often use transdermal estrogen + micronized progesterone, which appear to have a different risk profile than the old WHI drugs.

Bottom line:
For many appropriately selected women, especially those who start HRT within 10 years of menopause, the breast cancer risk looks small and highly dependent on the specific regimen.

Cardiovascular Disease & Stroke

• The original WHI findings showed higher stroke risk, but the analysis had multiple-comparison issues, and later corrections undercut the statistical significance.

• Oral estrogen can slightly increase clotting tendency; transdermal estrogen does not appear to increase clot risk the same way. 

• A 2015 Cochrane meta-analysis suggested that, started early (within 10 years of menopause), HRT may actually reduce cardiovascular events for some women, though not when started late. 

Bone, Brain, and Quality of Life

• HRT is the most effective known treatment for hot flashes and night sweats, often reducing symptoms by 60–90%. 

• It can improve sleep, mood, sexual function, and overall quality of life for many women.

• Estrogen helps maintain bone density and reduce fracture risk, which matters a lot for long-term independence. 

Important nuance:
There is active debate about how much HRT helps prevent heart disease or dementia long-term. The new labels intentionally avoid overstating benefits, just as the old ones overstated risks.

Potential Benefits (when appropriately prescribed)

Many of our patients in Elmhurst, Jackson Heights, Corona, Forest Hills, and Flushing seek HRT for:

• Severe hot flashes and night sweats

• Insomnia and “wired but tired” nights

• Brain fog and trouble concentrating

• Low mood, irritability, and low motivation

• Painful intercourse or vaginal dryness

• Lost libido

• Rapid loss of bone density (osteopenia/osteoporosis)

For the right patient, HRT can:

• Improve daily comfort and quality of life

• Help stabilize sleep and energy

• Support bone health

• Make it easier to exercise, maintain muscle, and protect long-term function

Key Considerations

Even with the new rules, we still look carefully at:

• Personal and family history (breast/uterine cancer, blood clots, stroke, heart disease)

• Metabolic health (blood pressure, glucose, cholesterol)

• Smoking status and weight

• Age and time since menopause

• Preference for transdermal vs oral vs local vaginal estrogen

HRT is a powerful tool—but like any tool, it’s safest in experienced hands.

At Leva Medical, hormone care is not an afterthought—it’s a dedicated service line within a family-run, board-certified practice with 35+ years in Queens.

What sets us apart:

• Doctor-led consults: Every hormone consultation is performed directly by a physician, not a coordinator.

• Personalized protocols: We combine symptoms, labs, and risk factors to design a tailored plan—dose, route, and schedule.

• Modern, evidence-based regimens: We use current data, including the latest FDA updates, to avoid outdated, higher-risk hormone combinations.

• Integrated care: Because we also address weight, metabolic health, and aesthetics, we can look at the whole picture (not just one lab number).

• Bilingual care: Our team speaks English and Spanish, which matters in a community where many patients are more comfortable in Spanish.

• Convenient Queens location: Near Queens Center Mall, easy to access from across the borough.

If you’re curious about whether hormone therapy is right for you, our Hormone Membership Programs for women and men can offer a more structured, monitored approach over time.