On Monday November 10, 2025, the FDA announced that it was removing the black box warning from menopausal hormone therapy products (MHT).
Here are 5 things we think you should know.
1. What is a black box warning? (see image below)
2. The best news from the announcement — vaginal estrogen.
3. The breadth of the FDA announcement was a surprise to many.
4. Two troubling parts of the FDA announcement.
- Important evidence about heart, brain and bone health and breast cancer was left out.
- The claims shared about MHT erroneously positioned it as a longevity drug (i.e., protective for heart and brain health).
5. See for yourself: Links to the transcript and video of the announcement and other perspectives.
If you take away one thing (and decide to read no further)
Before beginning any systemic menopausal hormone therapy (pill, patch, gel or spray), every person should have a conversation with a knowledgeable healthcare provider about their specific risks and benefits.
→ This guidance is and remains no different than before the FDA’s announcement.
1. What is a black box warning?
A black box warning is a safety warning — outlined in a thick black box on a drug’s packaging or on the accompanying information — mandated by the U.S. Food and Drug Administration (FDA) to alert healthcare professionals and patients that the drug carries significant risk such as dangerous side effects, contraindications in certain populations and risks of fatal drug interactions and to provide special instructions for safe use.
Before prescribing a medication with a black box warning, healthcare professionals are expected to review the risks with patients and evaluate whether the medication’s benefits outweigh its risks. This must be done in the context of the patient’s health history and other medications. Drugs with black box warnings can be effective treatments, but they warrant extra caution and patient education.
2. The best news from the announcement — vaginal estrogen
It was widely anticipated that the FDA would remove the black box warning from vaginal estrogen products. Vaginal estrogen refers to the local application of estrogen to vulvar and vaginal tissues. This can relieve painful sex, frequent urinary tract infections and vaginal itchiness/dryness. In the “menoverse”, where there is debate about seemingly every topic, there is almost universal agreement that vaginal estrogen does not warrant the black box warning about cancers, heart health, brain health and clots. So, this part of the FDA announcement was welcomed.
3. The breadth of the FDA announcement was a surprise to many
The announcement that the black box warnings were to be removed from systemic forms of menopausal hormone therapy products was not anticipated. These products, administered as transdermal patches, gels, a spray or an oral pill, all raise the blood (serum) levels of estrogen and enable estrogen to reach other areas of women’s bodies (i.e., our bones, our brains, our breasts, our hearts). Considerable disagreement remains about the benefits and risks of systemic estrogen, which is why the FDA’s blanket removal of black box warnings from all MHT products was such a surprise.
4. Two troubling parts of FDA’s announcement
The FDA announcement ignored debates among clinicians and researchers about the effects of systemic forms of MHT. Unfortunately, speakers at the FDA announcement did not present all the relevant scientific evidence about the effects of estrogen on bone health, heart health, brain health and breast cancer. Earlier this year, we examined the body of evidence about estrogen and heart health with Dr. Nanette Santoro. You can find that post here. These mixed findings about the benefits of estrogen were not shared by the FDA speakers. We also have a new in-depth review of the evidence on MHT and brain health with Dr. Pauline Maki here. In an upcoming post, we plan to share the evidence about the unfounded claim that there is no breast cancer risk with MHT.
Equally troubling was the FDA claim that “estrogen is one of the most effective longevity interventions for women”, as one person who spoke at the announcement said. Scientific support for the notion that menopausal hormone therapy is a so-called “longevity” drug for the prevention of heart disease is mixed at best and for and brain disease it is nonexistent. None of the considerable body of evidence that casts doubt on this claim was mentioned by the FDA.
Women are not well-served by one-sided pronouncements like the one put forth by the FDA last Monday. We deserve better.
5. Read and watch for yourself
- Watch the announcement on YouTube here.
- I’ve posted the full transcript of the announcement on the WLB blog here.
- An article in Mother Jones does a nice job of getting expert’s input on some claims that were made at the FDA panel.
- Watch Dr. Jen Gunter’s reactions to the panel here.
