HRT black box warning removed: top hormone doctor answers your questions
In the US the black box warning has been removed from HRT. As a Brit living in America, Donna Francis asks leading hormone specialist, Dr. Louise Newson, what the FDA's landmark decision means for women’s health on both sides of the pond
After months of hesitation and a lot of research, I began my HRT journey last year. I'd been battling anxiety, brain fog and hot sweats for months, and following an appointment with an online healthcare provider, I decided it was time to get my hormones back in control. Since then, my experience with HRT has been nothing short of lifechanging. It has allowed me to thrive, feel like myself again and truly embrace midlife. And that's why, as a Brit living in America, I'm so encouraged by the FDA's recent decision to remove the black box warning from HRT products for menopause. It not only makes me feel more confident about continuing my own HRT journey, but it also opens the door for so many more women to feel empowered and confident to do the same.
The FDA's ruling marks a huge shift in how women's health - particularly menopause care - is understood and supported. To unpack what this landmark decision means, and why it could transform the way HRT is prescribed worldwide, I spoke with leading UK menopause specialist Dr. Louise Newson, who has long campaigned for evidence-based information and better access to hormone therapy.
The future is brighter for women after the change in HRT
Dr Louise Newson on what the FDA's HRT decision means
Why is the FDA's decision to remove the black box warning on HRT so important?
"This is a pivotal time for the health of women across the world. For decades, warnings linking oestrogen to breast cancer, cardiovascular disease and dementia have needlessly scared women and healthcare professionals away from prescribing and taking HRT. These fears stem largely from the misinterpretation of the early 2000s Women's Health Initiative (WHI) study - a billion-dollar trial that was prematurely halted and misrepresented before its data were properly analysed."
What were the consequences of the misinterpretation of the WHI study?
"The result was catastrophic. Millions of women were left to struggle with debilitating symptoms and increased risks to their long-term health, all because of misinformation and misplaced fear."
Dr. Newson points out that after the study was published, HRT prescriptions plummeted from around 40 per cent to 4 per cent in the US and from 30 per cent to around 14 per cent in the UK, leaving millions of women suffering unnecessary symptoms and long-term health risks.
Has research always supported the safety of HRT?
"The evidence has always been clear: when prescribed appropriately, HRT is safe, effective, and protective."
Dr. Newson highlights that even as far back as 1941, research showed that women taking HRT had a lower risk of developing osteoporosis - a disease that affects half of all menopausal women and causes one in three to experience hip fractures.
Q: What did the WHI data really show when properly analysed?
When properly analysed, Dr. Newson explains that the WHI data showed a 24 per cent reduction in breast cancer risk in women taking oestrogen-only HRT while adding that no study has ever shown that body-identical hormones - which are structurally identical to the hormones naturally produced in women’s bodies - increase breast cancer risk.
"It makes no logical sense that our own hormones would cause cancer," explains Dr. Newson. "We have been hoodwinked, as women and as healthcare professionals, by years of poor science communication and institutional fear. But this FDA ruling represents a long-overdue step towards truth, compassion, and evidence-based care."
Q: Will the UK remove warnings on HRT too?
"It's time for the UK to follow suit, to review the data objectively, remove outdated warnings, and ensure women receive evidence-based care without stigma or fear. The FDA's action is a long-overdue recognition of the evidence that oestrogen, when prescribed appropriately, is not only safe but lifechanging for many women. This is not just a women's issue; it's a public health issue that affects families, workplaces and society as a whole."
Q: What does this moment mean for women's health globally?
"The future is brighter for women after this announcement. The science is clear: HRT is safe and effective. Now, we need our own health authorities to listen, learn and act. Women deserve nothing less."
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