The dates
- November 10, 2025: The FDA asks for the changeHHS and the FDA announce the removal of the boxed-warning language on heart disease, breast cancer and probable dementia from menopausal hormone therapy labels, and the FDA asks every maker to submit revised labels [1] [2].
- February 12, 2026: The first six labels changeThe FDA approves revised labels for six products, a first batch after 29 companies submitted changes, covering all four kinds of hormone therapy [3] [4].
- October 23, 2026: Still six on the FDA’s listThe FDA’s list of relabeled products still shows the same six, under a stamp of February 12, 2026, and many estradiol patch, tablet and vaginal labels on DailyMed still carry the older boxed warning [4] [5] [6].
What changed
For every menopausal hormone therapy, systemic and vaginal, the FDA asked makers to make three changes to the boxed warning, the black box at the top of the label [2]:
- Remove the heart disease, breast cancer and probable dementia language from the box. The probable dementia warning also comes out of the rest of the label [2].
- Remove the endometrial cancer language, except on systemic estrogen-alone products [2].
- Remove the advice to use the lowest effective dose for the shortest time [2].
For systemic products, those that treat the whole body, labels now add that starting hormone therapy for moderate to severe hot flashes can be considered in women under 60 or within 10 years of menopause, and add the Women’s Health Initiative results for women aged 50 to 59 [2]. The HHS release noted that the average woman in that study was 63 [1], and the FDA notes that the average age of menopause in the US is 51 [2].
What stays
- The endometrial cancer boxed warning on systemic estrogen alone. Estrogen without a progestogen can cause endometrial cancer in a woman with a uterus, so that warning stays in the box [1]. On the relabeled Divigel® gel it is now the only boxed warning [7].
- The heart disease and breast cancer warnings themselves. They move out of the box but stay in the label’s Warnings and Precautions [2] [8].
- Who should not use hormones. Unexplained bleeding, breast cancer, a past blood clot, stroke or heart attack, and liver disease are still listed as reasons not to take estrogen [7].
Vaginal estrogen is handled on its own terms: its labels are to condense their safety information to what matters for a local, low-dose product [2]. Estring®, the first vaginal product relabeled, has no boxed warning on its current label [9].
Which products have been relabeled
| Product | FDA category | What it is |
|---|---|---|
| Prometrium® | Progestogen alone | Micronized progesterone capsules [10] |
| Divigel® | Systemic estrogen alone | Estradiol gel [7] |
| Cenestin® | Systemic estrogen alone | Synthetic conjugated estrogens tablets |
| Enjuvia® | Systemic estrogen alone | Synthetic conjugated estrogens tablets |
| Estring® | Topical vaginal estrogen | Estradiol vaginal ring [9] |
| Bijuva® | Systemic estrogen plus progestogen | Estradiol and progesterone capsules |
Every other product keeps its current label until its maker’s revision is approved. On October 23, 2026, the Climara® patch, generic estradiol tablets, Estrace® vaginal cream and Vagifem® inserts still showed the older box on DailyMed [5] [11] [12] [6]. So the box on your pharmacy leaflet may not match what the FDA now says.
What it means for you
- The risks did not vanish; the framing changed. The FDA moved heart disease and breast cancer out of the box and kept them in the warnings [8]. In absolute terms, the Women’s Health Initiative found 8 more invasive breast cancers and 8 more strokes per 10,000 women a year on estrogen with a progestin [13].
- Timing matters. The Menopause Society says the benefit-risk balance is favorable for women under 60 or within 10 years of menopause without a reason to avoid hormones, and less favorable when therapy starts later [14]. Read can I start HRT after menopause?.
- If you have a uterus, you still need a progestogen with estrogen. The one boxed warning that stays is the reason: see progesterone.
- There is no arbitrary stop age. The Menopause Society says hormone therapy does not need to be routinely stopped at 60 or 65 [14].
- Compounded hormones have no FDA label to change. The change applies to FDA-approved products. Compounded hormones, including VevaMD’s estradiol skin cream and capsules and its testosterone cream, are not FDA-approved [15]. Read bioidentical vs compounded vs pellets.