Last checked September 2026 against 20 sources · Editorial policy
News about HRT and FDA updates
The biggest HRT news: on November 10, 2025, the FDA began removing boxed warnings about heart disease, breast cancer and dementia from menopause hormone therapy. By February 12, 2026, it had approved new labels for the first products, and 29 companies had submitted changes. The FDA also approved a generic Premarin and the non-hormonal hot flash drug Lynkuet in 2025. In September 2026, it said estradiol patch supply had nearly doubled as demand rose.
The latest on menopause hormone therapy: FDA boxed warning changes, new drug approvals, patch supply and guidelines, with what each means for you.
HRT news: expectation vs reality
What people often expect
“The FDA now says HRT has no risks”
What the evidence shows
The FDA removed the boxed warnings, not the risks. Labels still describe heart disease and breast cancer risks under Warnings and Precautions, and estrogen-alone products keep a boxed warning about endometrial cancer. The new labels say to consider starting HRT before age 60 or within 10 years of menopause, when benefits outweigh risks for most women.
Latest HRT news and FDA updates
FDA removes HRT boxed warnings (November 2025)
On November 10, 2025, the FDA asked makers of all menopause hormone therapies, including vaginal estrogen, to remove statements on cardiovascular disease, breast cancer and probable dementia from the boxed warning. It also dropped the advice to use the lowest dose for the shortest time. Systemic estrogen-alone products keep the endometrial cancer warning, and labels add WHI data for women aged 50 to 59.
Learn more →Why the FDA changed the HRT warnings
The boxed warnings came from the WHI trials, whose participants averaged 63 years old, while US women reach menopause at 51 on average and hot flashes typically start between 45 and 55. The FDA also found HRT under-used: in 2020, about 41 million US women were aged 45 to 64, about 34% of women aged 45 to 65 had moderate to severe hot flashes, but only about 2 million received a prescription.
New HRT labels approved (February 2026)
On February 12, 2026, the FDA approved the first updated labels, covering Prometrium, Divigel, Cenestin, Enjuvia, Estring and Bijuva, which span all four HRT categories. At that point 29 companies had submitted proposed changes. Updates are rolling out product by product, so some labels still show the old boxed warning. Divigel's new label, for example, keeps only the endometrial cancer warning.
FDA approves first generic Premarin in 30+ years
Alongside the warning changes in November 2025, the FDA approved a generic version of Premarin (conjugated estrogens) tablets, the first in more than 30 years. The FDA expects it to improve affordability and access with the same quality, safety and effectiveness as the brand. Conjugated estrogens are the estrogen used in the WHI trials.
Learn more →FDA-approved non-hormonal drugs: Lynkuet and Veozah
The FDA has approved three non-hormonal treatments for hot flashes. Veozah (fezolinetant, 45 mg daily) was approved in 2023, and Lynkuet (elinzanetant, 120 mg at bedtime) in 2025. In December 2024, Veozah got a boxed warning for rare but serious liver injury, with liver blood tests before and during treatment. In August 2026, Lynkuet's label added a warning about seizure risk. Brisdelle, a low-dose paroxetine, is the third.
Learn more →FDA update on estrogen patch supply (September 2026)
Demand for HRT rose after the November 2025 action, and some estradiol patches became hard to find. In its September 3, 2026 update, the FDA said patches remain available, supply nearly doubled over the past year, and it's working with all six manufacturers. Estradiol isn't on the FDA's drug shortage list. Pharmacists can often substitute another FDA-approved patch.
Learn more →HRT guidelines now: USPSTF and NICE
The US Preventive Services Task Force still recommends against HRT to prevent chronic conditions such as heart disease in women without symptoms (its 2022 recommendation). That doesn't apply to treating hot flashes or vaginal dryness, or to women with early or surgical menopause. The WHI investigators reached the same conclusion: not for disease prevention, but appropriate for symptoms. NICE last updated its menopause guideline in April 2026.
FDA-approved menopause supplements: there aren't any
Under the 1994 supplement law (DSHEA), supplement makers are responsible for the safety and labeling of their products before sale, and the FDA can act only after a product reaches the market. So no menopause supplement is FDA-approved the way HRT, Veozah or Lynkuet are. Compounded "bioidentical" hormones aren't FDA-approved either; a 2020 national academies review called their widespread use a public health concern.
Learn more →Hormone replacement news by the numbers
From the studies on this page
of women aged 45 to 65 have moderate to severe hot flashes
34%
41 million
29
30+ years
This page covers FDA and guideline news through September 2026; label updates continue product by product.
What the FDA news means for your HRT
Thinking of starting HRT under 60
First stepThe new labels say to consider starting systemic HRT for moderate to severe hot flashes in this group, where randomized studies show lower all-cause mortality and fewer fractures. Discuss your own risks with a doctor.
Related guide →Already taking HRT
First stepNothing about your medicine has changed, only the label. Keep up a yearly review, and don't stop or switch without talking to your prescriber.
Related guide →Vaginal estrogen and the FDA changes
Strong evidenceThe FDA asked for the boxed warnings on vaginal estrogen to go and for its labels to focus on what matters for a local product. Estring was among the first updated labels.
Related guide →Non-hormonal options if HRT isn't for you
Strong evidenceVeozah, Lynkuet and Brisdelle are FDA-approved non-hormonal options for hot flashes; gabapentin and other antidepressants are used off-label.
Related guide →Menopause supplements and the FDA
Limited evidenceNot reviewed by the FDA before sale, and none is approved to treat menopause symptoms.
When to talk to a doctor about the HRT news
You avoided or stopped HRT because of the old warnings
If you still have symptoms and are under 60 or within 10 years of menopause, ask whether HRT makes sense for you now.
More →You have a uterus and use estrogen alone
Ask about a progestogen. The endometrial cancer warning on estrogen-alone products hasn't changed.
Urgent: Signs of liver problems while taking Veozah
Contact your prescriber right away about unusual tiredness, nausea, itching, light-colored stools, yellow eyes or skin, dark urine or pain in the upper right abdomen.
More →You're over 60 and thinking of starting HRT
Discuss it carefully. After 60 the risks may start to outweigh the benefits, and a low dose with patches or gel is often suggested.
HRT news and FDA changes: questions women ask
What is the latest news about HRT?
In November 2025 the FDA began removing boxed warnings on heart disease, breast cancer and dementia from HRT, and approved the first updated labels in February 2026. In September 2026 it said estradiol patch supply had nearly doubled as demand grew.
Did the FDA remove the black box warning on HRT?
Mostly. Statements on cardiovascular disease, breast cancer and probable dementia are being removed from the boxed warning for all HRT. Systemic estrogen-alone products keep a boxed warning on endometrial cancer, and labels are updated product by product.
Why did the FDA remove the HRT warnings?
The FDA said the warnings rested on WHI trials in women averaging 63, older than typical HRT users, and that they led many women with symptoms to avoid treatment. It reviewed the literature, held an expert panel in July 2025 and took public comment.
Is HRT safe now?
The risks haven't changed, only how the label presents them. Heart disease and breast cancer are still listed under Warnings and Precautions. For most women who start before 60 or within 10 years of menopause, the FDA and HHS say benefits outweigh risks.
Related →What does the FDA now say about when to start HRT?
The updated labels recommend considering systemic HRT for moderate to severe hot flashes in women under 60 or within 10 years of menopause. The FDA says timing and how long to stay on it are decisions for you and your prescriber.
When will all HRT labels be updated?
The FDA hasn't set a date. It approved the first six updated labels in February 2026, 29 companies had submitted changes by then, and the FDA says more companies may make changes. Until your product's label is updated, it may still show the old boxed warning.
Are there FDA-approved menopause supplements?
No. The FDA doesn't approve supplements before they're sold; under the 1994 law, makers are responsible for safety and labeling, and the FDA acts only after a product reaches the market. FDA-approved treatments for hot flashes are prescription drugs.
What new menopause drugs has the FDA approved?
Lynkuet (elinzanetant), a non-hormonal hot flash pill, was approved in 2025, following Veozah (fezolinetant) in 2023. In November 2025 the FDA also approved the first generic Premarin in more than 30 years.
Does vaginal estrogen still have a boxed warning?
The FDA asked makers of all HRT, including vaginal estrogen, to remove the boxed warnings on heart disease, breast cancer and dementia. Estring's label was among the first six updated in February 2026; others follow as they're approved.
Related →Has the USPSTF changed its HRT recommendation?
No. Its 2022 recommendation against using HRT to prevent chronic conditions still stands. It doesn't apply to treating hot flashes or vaginal dryness, or to women with early or surgical menopause.
Sources
- US Food and Drug Administration. HHS advances women's health, removes misleading FDA warnings on hormone replacement therapy. November 10, 2025.
- US Food and Drug Administration. FDA approves labeling changes to menopausal hormone therapy products. February 12, 2026.
- Prescribing information: Lynkuet (elinzanetant capsules). Bayer HealthCare, 2026. DailyMed, US National Library of Medicine.
- US Food and Drug Administration. FDA update on estradiol transdermal patch availability. September 3, 2026.
- US Food and Drug Administration. Hormone replacement therapies can help women with bothersome menopausal symptoms.
- US Food and Drug Administration. FDA requests labeling changes related to safety information to clarify the benefit/risk considerations for menopausal hormone therapies. 2025.
- US Department of Health and Human Services. Fact sheet: FDA initiates removal of "black box" warnings from menopausal hormone replacement therapy products. 2025.
- US Food and Drug Administration. Menopausal hormone therapies with updated prescribing information. 2026.
- Prescribing information: Divigel (estradiol gel 0.1%). Vertical Pharmaceuticals, 2026. DailyMed, US National Library of Medicine.
- Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013;310(13):1353-68.
- Prescribing information: Veozah (fezolinetant tablets). Astellas Pharma, 2026. DailyMed, US National Library of Medicine.
- US Food and Drug Administration. Drug safety communication: FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant). December 2024.
- Prescribing information: Brisdelle (paroxetine 7.5 mg capsules). Legacy Pharma, 2025. DailyMed, US National Library of Medicine.
- US Food and Drug Administration. Drug Shortages database, searched for estradiol and progestogens (data as of September 26, 2026).
- US Preventive Services Task Force. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. 2022.
- NICE. Menopause: identification and management (NG23). Updated 2024.
- US Food and Drug Administration. Dietary supplements.
- US Food and Drug Administration. NASEM study on the clinical utility of treating patients with compounded "bioidentical" hormone therapy.
- NHS. When to take hormone replacement therapy (HRT).
- The North American Menopause Society. The 2023 nonhormone therapy position statement of The North American Menopause Society. Menopause. 2023;30(6):573-590.
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