Female hormone deficiency – correcting misinformation

Last week saw one of the most significant announcements from the Food and Drug Administration (FDA) in the USA – a statement that could influence the health and wellbeing of millions of women.¹ And yet, this event passed with little or no comment from most mainstream media channels.

In fact, the announcement from FDA Commissioner Marty Makary corrected misinformation that had been allowed to stand for more than two decades. Following publication of the Women’s Health Initiative (WHI) trials in 2002 and 2004, ‘black box’ warnings about the perceived risks of oestrogen therapy were added to the labels of all oestrogen and combined oestrogen-progesterone treatments. The warnings listed the serious risks reported in the trials – cardiovascular disease, thromboembolism, breast cancer and probable dementia.

The result was that many clinicians became reluctant to prescribe HRT and many women, spooked by early headlines that ‘HRT causes breast cancer’, discontinued their HRT.  In fact, the WHI study did NOT show that HRT causes breast cancer (as later analysis showed) but the message stuck and few people bothered to go back and look at the findings. It is estimated that some 50 million women have been prevented from experiencing the benefits of HRT as a result.

The WHI study used oral conjugated equine oestrogens (CEE) and medroxyprogesterone acetate and started treatment in older women – factors that make it difficult to generalise the results to present-day women in their 50s taking body-identical hormones, often by the transdermal route.

Over the intervening years, much has been made of the perceived risks of HRT, but little emphasis has been given to the benefits, some of which have been known for decades.

As Makary says,

“Hormone therapy has also been associated with a 25% to 50% reduction in fatal cardiovascular events (the leading cause of death in women), a 50% to 60% reduction in bone fractures, a 64% reduction in cognitive decline, and a 35% decreased risk of Alzheimer disease …….

“With the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy.”¹

The FDA updates not only remove the black box warnings described above but also remove the recommendation to prescribe HRT at the lowest effective dose for the shortest possible time.  Furthermore, safety information for topical vaginal oestrogen products will be relevant to this presentation rather than the broad warnings for systemic oestrogens.

These changes set the scene for a better future for many women. However, there is still much work to be done to combat the “outsized fear” of HRT.  The absence (so far) of statements from medical colleges and professional bodies is disappointing. Social media posts are still full of women saying their doctors decline to prescribe HRT because of the link with breast cancer (for which there is no evidence) or because they “don’t believe in it”!

For too long HRT has been associated with scaremongering and misinformation. Let us hope that this initiative from the FDA helps to drive “a meaningful shift toward more nuanced, evidence-based communication of hormone therapy risks — one that prioritises clinical relevance, distinguishes between different formulations and patient populations, and balances the narrative to reflect both safety and therapeutic value.”¹

Reference

Makary MA, Nguyen CP, Høeg TB, Tidmarsh GF. Updated Labeling for Menopausal Hormone Therapy. JAMA. Published online November 10, 2025. doi:10.1001/jama.2025.22259