FDA removes ‘black box’ warning from HRT: what this means for women’s hormone health
Write your awesome label here.
What has the FDA actually changed?
For decades, HRT products in the US carried prominent “black box” warnings suggesting increased risks of breast cancer, heart disease, stroke and dementia. These warnings were introduced after early interpretations of the Women’s Health Initiative (WHI) trial, which have since been shown to be incomplete and, in some respects, misleading. Harvard Health+1
Following a comprehensive review of the evidence, expert advisory meetings and public consultation, the FDA has now: Society of Gynecologic Oncology+3U.S. Food and Drug Administration+3HHS+3
Following a comprehensive review of the evidence, expert advisory meetings and public consultation, the FDA has now: Society of Gynecologic Oncology+3U.S. Food and Drug Administration+3HHS+3
- Requested the removal of broad warnings from all FDA approved estrogen-containing menopausal hormone therapy products
- Asked manufacturers to update labels to reflect current data on benefits and risks
- Retained a boxed warning for endometrial cancer on systemic estrogen-only therapy in women, because of the risk when used alone in women with a womb.
Why this matters for the hormone health of women
The FDA’s decision is not about “promoting” hormones - it is about setting the record straight so women and clinicians can make informed decisions based on up-to-date science rather than outdated fear. Evidence now shows that, for many healthy women who start HRT around the time of menopause: Society of Gynecologic Oncology+3HHS+3EMAS+3
The greatest problems over the last two decades have come from underuse and withdrawal of HRT in women who could have safely benefited not from appropriate treatment itself.
- Benefits (such as symptom relief, bone protection and cardiometabolic advantages) often outweigh the risks
- Risks are generally low when doses, types of hormones and routes of delivery are individually tailored.
The greatest problems over the last two decades have come from underuse and withdrawal of HRT in women who could have safely benefited not from appropriate treatment itself.
Write your awesome label here.
Dr Louise Newson’s perspective
Newson Education founder Dr Louise Newson has long campaigned for better evidence-based information about HRT and more equitable access to treatment. She described the announcement as a momentous time in history for women, reversing years of fear and misunderstanding around menopause hormone therapy.
Key points of alignment with her work include:
For Dr Newson, the FDA’s move supports what clinicians focused on women’s hormone health have been seeing in practice for years - that appropriately prescribed HRT can be safe, effective and transformative for many women struggling with menopausal symptoms and longer-term health risks.
Key points of alignment with her work include:
- Evidence over fear: regulatory guidance should reflect robust data, not misinterpreted early analyses that exaggerated risk for most women
- Individualised care: the decision reinforces the need to consider each woman’s age, symptoms, health history and preferences when discussing HRT.
- Global impact: although this is a US regulatory decision, it sends a strong signal internationally that hormone healthcare for women must be guided by current evidence.
For Dr Newson, the FDA’s move supports what clinicians focused on women’s hormone health have been seeing in practice for years - that appropriately prescribed HRT can be safe, effective and transformative for many women struggling with menopausal symptoms and longer-term health risks.
Write your awesome label here.
What does this mean for clinicians in the UK or outside the US?
While the FDA regulates medicines in the US, its decisions often influence how menopause care is viewed around the world. Professional societies in Europe and elsewhere have welcomed the change as consistent with their own evidence-based guidance on menopausal hormone therapy. EMAS+1
For women and clinicians outside the US, this announcement:
For women and clinicians outside the US, this announcement:
- Adds further weight to existing evidence that, for many women, the benefits of HRT outweigh the risks
- Highlights the importance of up-to-date training and guidance for healthcare professionals on menopause and hormone health
- Underscores the need to review local policies and practice so that women are not denied treatment because of outdated fears.
The bottom line
The removal of the FDA’s “black box” warning means:
- Women deserve clear, balanced information about HRT - not scare stories
- Decisions about treatment should be made in partnership with a knowledgeable clinician, based on individual benefits and risks
- Globally, health systems need to take menopause and hormone health seriously as a core part of women’s healthcare, not a niche issue.
Want to learn more about evidence-based menopause care?
Explore our programmes and resources on safe, personalised hormone healthcare for women.