FDA Announcement: A pivotal time for the health of women
10 November 2025 marks a momentous time in history for women. The Food and Drug Administration (FDA) commissioner Dr Marty Makary has announced in a public meeting that the warnings for estrogen products in hormone replacement therapy (HRT) and vaginal hormones are going to be removed.
For decades, the warnings of breast cancer, cardiovascular disease and dementia have been needlessly scaring women away from being prescribed hormones.
Much of this fear stems from the ill-fated Women’s Health Initiative (WHI) study, which was a billion dollar study that was halted early due to perceived risks of (HRT). Some of the researchers wrote a press release that went to the mainstream media and to the medical press before this study was analysed properly. The headlines were that “HRT causes breast cancer” and “HRT causes heart attacks” so women across the world were actively encouraged to stop taking HRT.
HRT prescribing literally fell off a cliff – before the study around 40% of menopausal women in the US and 30% of menopausal women in the UK were prescribed HRT and now it is around 4% and 14% respectively. This has resulted in millions of menopausal women suffering with symptoms and health risks with their low hormones.
Understanding the benefits of HRT
Even in 1941, it was discovered that women taking HRT had a lower future risk of developing osteoporosis – this is very significant as around one in two menopausal women have osteoporosis and around one in three menopausal women sustain a hip fracture due to osteoporosis.
In the 1970s, HRT was one of the most commonly prescribed drugs and there was increasing evidence reporting the many benefits of HRT – both for symptom improvement and for improving future health.
Women taking HRT have been shown to have a lower future risk of developing cardiovascular disease, including heart attacks and strokes, with some studies showing around a 50% risk reduction – so even better than results with statins.
The WHI also showed that women taking HRT had a dramatic reduction in bowel cancer and diabetes – both common conditions – yet this was largely ignored too.
Spreading fear among women
Most women are scared of HRT and most healthcare professionals are still refusing to prescribe HRT as they are scared about the perceived risk of breast cancer. But that is what it is – an alleged risk that has petrified women across the world with no good quality evidence to support this.
Even the WHI study – when analysed properly – showed a 24% reduction in risk of developing breast cancer in women taking oestrogen-only HRT and there has never been a study showing that women who take body identical hormones have a greater risk of developing breast cancer. After all, body identical hormones are the same structure as our own hormones so why would they cause cancer? It makes zero logical sense.
As menopausal women, we have been hoodwinked. As healthcare professionals, we have been deceived.
For many years, the more inquisitive and professionally curious clinicians amongst us have kept asking questions, challenging the statements, and even probing the authorities regarding the reasons for so many women being denied HRT without any good evidence.
We have been talking more openly about the harms of not prescribing HRT to women – the harms of symptoms, especially the mental health symptoms, the harms of future diseases occurring, the harms to home and family lives, the harms of leaving jobs due to symptoms such as memory problems, fatigue and anxiety, and the harms of simply being refused an evidence-based treatment.
Following the evidence
Yet the evidence has always been there – that hormones are safe and effective. Millions of women have been, and continue to be, harmed with scaremongering and misinformation about hormones.
We have heard in the meeting today that the science is clear – HRT is safe and effective and women’s health has been at risk and tens of millions of women have suffered needlessly.
Dr Marty Makary, Dr Rachel Rubins and Dr Kelly Casperson have all been on my podcast and it is a privilege to know them and watch them stand up and share their knowledge and passion for making a difference.
The future is brighter for women after this announcement – I hope other countries do the same and stop harming women with fear and deception about hormones.
Authored by Dr Louise Newson, BSc(Hons) MBChB(Hons) MRCP(UK) FRCGP, Founder of Newson Education
