Menopause
Doctors push back on ‘data-free’ ruling on menopause hormone therapy
Medical experts say the FDA bypassed standard procedures to remove black-box warnings from hormone therapy without adequate scientific evidence.
The US Food and Drug Administration commissioner Marty Makary announced the removal of broad black-box warnings from oestrogen-related menopause medications last week, claiming the treatments could prevent heart disease, osteoporosis, Alzheimer’s disease and death.
Black-box warnings are the strongest safety alerts the FDA requires on medications, highlighting serious or life-threatening risks. The 2003 warnings on hormone therapy cautioned about increased risks of cardiovascular disease, breast cancer and dementia.
Menopause specialists said the decision to remove warnings makes sense for local vaginal oestrogen products but raised concerns about systemic oestrogen treatments and the scientific process behind the ruling.
To make that blanket statement that every woman should take this to prevent heart disease – it’s not true,” said Lauren Streicher, clinical professor of obstetrics and gynaecology and founding medical director of the Center for Sexual Medicine and Menopause at Northwestern University school of medicine.
The FDA used a roundtable panel instead of its typical expert advisory committee process, marking the first time the agency has relied on this format for regulatory decision-making. The panel was not open to public comments in advance.
Makary called hormone therapy a “life-changing, even life-saving treatment” and positioned the announcement as a “medical breakthrough”. Robert F Kennedy Jr, secretary of the US Department of Health and Human Services, claimed hormone therapy was “extending the lives for as much as 10 years”.
“There may be no other medication in the modern era that can improve the health outcomes of women on a population level than hormone replacement therapy,” Makary said at the press conference.”
However, researchers said there is no evidence that hormone therapy provides benefits for the wider population of menopausal women beyond those experiencing symptoms such as hot flushes, insomnia and joint pain.
Pauline Maki, professor of psychiatry, psychology and obstetrics and gynaecology at the University of Illinois college of medicine, called the “data-free” decision “harmful” and confusing for women seeking accurate information.
“Women are trying desperately to get the truth, and they’re having a really difficult time,” she said. Regarding hormone therapy for dementia prevention, her area of expertise, “the harm is maybe real, but certainly it’s not showing benefit.”
Streicher, who initially agreed to participate in the July panel, withdrew after preliminary meetings. “It became very clear to me that this was not going to be a scientific panel. This isn’t the scientific approach,” she said. “I said: ‘I’m out. I don’t want any part of this.'”
The evidence on hormone medications is nuanced. Local vaginal oestrogen, typically delivered as creams, tablets, inserts, suppositories or vaginal rings, treats symptoms like dryness, irritation and recurrent urinary tract infections safely. “Those products are really totally safe,” Streicher said, noting they never should have carried the warning.
Systemic oestrogen presents more complexity. Different preparations carry varying risks. Oral oestrogen increases blood clot risk, while transdermal patches do not. Synthetic progesterone carries a small increased breast cancer risk. The medications are unsuitable for people with histories of breast or uterine cancer.
Maki’s research on menopause and dementia illustrates the complexity. She once believed memory issues could be linked to oestrogen loss during menopause. Initial research suggested women using hormone therapy for menopause symptoms saw memory improvements.
However, when Maki conducted a large randomised study among a broader group of menopausal women, not just those with symptoms, results differed significantly. “Far from showing benefit, it actually showed a trend toward harm,” Maki said. Three other large randomised trials produced similar results.
Maki now believes treating menopause symptoms, whether with hormone therapy or other medications, is key to improving memory. Using hormone therapy for dementia prevention more widely is “just not based in science”, she said.
An HHS spokesperson said “randomised studies show that women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures”. The HHS did not respond to questions about officials’ statements on purported protection against dementia or provide evidence for wider use of the medications.
During the press conference, officials positioned the decision as challenging “medical group think” and “medical dogma”. Kennedy said “the label was designed to frighten women and to silence doctors” and accused the American medical establishment of turning its back on women.
Makary said the decision was “challenging the paternalism of medicine”, but then stated hormone therapy “has saved marriages”, suggesting marital satisfaction as a key outcome of the medication.
“It was not only scientifically wrong, but it was offensive,” Streicher said.”
The FDA opted for the panel format because advisory committee meetings are “bureaucratic, long, often conflicted and very expensive”, Makary said. He indicated more panels with guests who “speak [their] mind passionately” will occur in future.
Typically, expert advisory committees hold public discussions on evidence before making recommendations to the FDA, which subject-matter experts at the agency, rarely the commissioner, may accept or reject. The July panel included researchers who have published on menopause and doctors with large social media followings, but no oncologists.
Makary’s most recent book includes a chapter on hormone replacement therapy arguing that it has been shown to “increase a woman’s longevity by three years”. The more accepted medical term for treatment for women over 40 is menopause hormone therapy.
Streicher expressed concern about precedents set by the decision, noting the agency is also re-examining medications like mifepristone, a safe and effective abortion medication.
“Hormone therapy is safe and effective for those with menopause symptoms,” Streicher concluded. “But do I tell every single woman who goes through menopause that she needs to be on hormone therapy? Absolutely not.”
Brain fog in menopause is common but still poorly understood, with researchers calling for more work to explain the link and how best to support women.
For a new perspective article published in The Lancet Obstetrics, Gynaecology, & Women’s Health, researchers based in the UK and Australia reviewed the evidence on menopause-related cognitive symptoms. They found that symptoms such as forgetfulness, reduced concentration and brain fog are common during the menopause transition, but are still poorly recognised and under-researched.
More than two-thirds of women report difficulties with memory or concentration over the menopause transition. Multiple factors may contribute to these cognitive symptoms, including hormonal changes, sleep disturbances and psychological and psychosocial stress. Yet, because cognitive symptoms are not widely discussed, they can cause considerable worry, with some fearing they are signs of dementia or undiagnosed neurodevelopmental conditions.
The review paper emphasises that overall cognitive performance for women experiencing menopause-related brain fog typically remains within expected ranges and, importantly, that cognitive symptoms are not linked to an increased risk of dementia.
Professor Aimee Spector of UCL Division of Psychology and Language Sciences, co-author on the paper, said: “Cognitive symptoms such as forgetfulness and ‘brain fog’ are incredibly common during menopause, yet they are often overlooked. Our findings highlight just how complex menopause-related cognitive symptoms are, and how much we still don’t know about what drives them. More targeted research is essential if we are to identify which biological, psychological or lifestyle factors contribute most, and what types of support or treatment are likely to be effective.”
The authors argue that clinicians can play a key role in understanding and validating women’s experiences by asking about the duration of cognitive symptoms, impacts on day-to-day functioning and any other medical or psychosocial factors that could be contributing to cognitive symptoms.
The review also discusses a range of approaches that may ease cognitive symptoms, such as improving sleep quality, engaging in regular aerobic exercise and eating a balanced diet. There is also little but promising research into the impact of psychological therapies targeting cognitive symptoms, with a recent meta-analysis of three cognitive behavioural therapy-based studies showing significant improvements in memory and concentration. The evidence is more mixed for the benefits of hormone therapy on cognitive symptoms during menopause.
The authors identify cognitive symptoms as a major area of unmet need in menopause research. They call for a unified definition of menopause-related cognitive changes and for prospective, longitudinal studies that can track women from pre- to post-menopause. Better understanding of the biological, psychological and social factors that contribute to cognitive symptoms will be crucial for developing effective treatments.
Lead researcher Dr Caroline Gurvich of Monash University said: “There’s a lot of pressure to use objective measures of cognitive decline, like a memory test, for example, in a clinical trial, but the key symptom of brain fog is a subjective experience. So having a definition that acknowledges the key cognitive symptom is critical.”
This is not without precedent – we already use subjective or self-report measures for depression, anxiety and other mental health conditions with great success.
Dr Gurvich said the proposed definition would also validate women’s individual experiences while empowering them through the reassurance that any objective decline in their cognitive ability is subtle.
She added: “This is a decrease in cognitive or learning efficiency, not functionality or capacity. For many women, the perception they are losing capacity is what drives them to stop work or lose the confidence to live fulfilling lives during and after menopause. I hear all the time from women who have gone through menopause that validation would have made a significant difference to their resilience and the approach they took to living with menopause.”
Co-author Professor Martha Hickey of the University of Melbourne and Royal Women’s Hospital said: “Our analysis of the best available research shows that many women experience some degree of cognitive symptoms, such as brain fog, during the menopause transition.”
“But there’s a lack of long-term data, which means that there’s a gap in our knowledge about how the brain fog symptom develops and changes from peri-menopause to after menopause ends. It’s a real gap in our understanding.”
Professor Spector added: “We increasingly see women, typically at the peak of their careers, losing confidence in the workplace, often translating to leaving work or reducing work hours. Having simple strategies to support and retain them at work is also a broader economic issue.”
Mariella Frostrup has been appointed the government’s women’s employment ambassador, a new role to support working women across the UK.
The new role comes as the government steps up efforts to support women with menopause symptoms, with businesses being encouraged to publish action plans aimed at tackling the £1.7bn lost each year through sick days, lost productivity and women leaving the workforce because of menopause.
The women’s employment ambassador role expands the remit of the menopause employment ambassador post, which Mariella Frostrup held over the past year.
In that role, she oversaw the launch of the Menopause Advisory Group and discussions with hundreds of employers to improve workplace support for women experiencing menopause.
In the expanded role, Frostrup will work closely with employers across the country to raise awareness of key health issues affecting women at work and champion the economic contribution women make.
Experts from across sectors will be brought together to gather evidence, identify barriers and opportunities, and provide informed recommendations on supporting women’s health at work.
Frostrup said: “Menopause support in the workplace has come a long way, and that progress is something to be proud of, but it cannot be where our ambition stops.
“Women’s health affects their working lives long before menopause, and for too long many have been navigating these challenges without the right support around them.
“Every woman deserves to know, at every stage of her career, that her health will not be a barrier to her success.
“I am delighted to take on this role and look forward to working with employers across the country support their imperative female workforce and retain them.”
Many health conditions affect women long before they reach menopause, including endometriosis and fibroids, making it vital that support is available throughout their working lives to stop women dropping out of the workforce for good.
This comes as part of the government’s drive to reverse the rise in the number of women who are economically inactive because of long-term sickness, which has hit a near-record high of 1.48 million.
Large businesses with 250 or more employees are also being encouraged to produce and publish voluntary action plans setting out how they will support employees experiencing menopause symptoms in the workplace.
Companies will be asked to commit to at least one action to support employees experiencing menopause, such as setting up support groups, tailored workplace adjustments including alternative uniforms, and more.
Dame Diana Johnson, minister for employment, said: “Too many women still face barriers that prevent them from reaching their full potential in the workplace.
“This new ambassador role sends a clear signal that we are serious about changing that, and Mariella Frostrup is the ideal person to take this on.
“By championing the brilliant contributions women make – as entrepreneurs, workers, and leaders – we can unlock economic growth that benefits everyone.”
The action plans are one part of the Employment Rights Act, which will boost employment and improve job security for more than 18 million workers and will benefit women balancing health, care responsibilities and careers.
Tracy Black, CBI chief commercial officer, said: “Businesses are committed to taking action to help women both stay and succeed in the workplace.”
“Awareness of the impact of menopausal symptoms at work is rising, leading to businesses taking a more pro-active approach to providing support. This is part of a wider trend of firms sharpening their focus on health and wellbeing.”
The women’s health ambassador, alongside the government’s renewal of the women’s health strategy, are working to make faster, more decisive progress on the health outcomes that matter most to women and girls across the country.
These measures, along with the new ambassador role, are intended to ensure employers are better equipped to support women and that women know how to access help throughout their career. Supporting women into work and throughout their career is a key part of the government’s commitment to Get Britain Working.
From spring 2026, employers with 250 or more employees will have the option to produce and publish a voluntary action plan alongside their gender pay gap.
A cooling bracelet for menopause relief is entering Ireland’s growing non-medical women’s health tech market.
The MyCelsius bracelet, worn like a wrist watch, entered the Irish market on 7 April 2026 and has been co-developed by Aonghus O’Donovan.
It works by cooling users’ wrists by 10C in under 10 seconds and is designed to reduce the discomfort of hot flushes.
Co-founders O’Donovan, 33, and Maxime Kryvian, 37, chief executive of the start-up cooling tech company, say it has an 80 per cent efficacy rate for women experiencing one of the most uncomfortable perimenopause and menopause symptoms.
O’Donovan spent three years researching the cooling bracelet, which lowers local skin temperature, helping the entire body feel cooler in moments of sudden heat.
The MyCelsius bracelet is a non-medical device and represents the culmination of three years of research and development.
The cooling system is claimed by O’Donovan to be five times more powerful than competitors’ devices.
O’Donovan said: “The wrist is one of the most thermally sensitive parts of your body and applying cold to it sends a signal to the hypothalamus (the body’s thermostat), to stop the sweating and flushing associated with a hot flush.”
“It uses advanced thermo-electric cooling to create a soothing, cold sensation directly onto the wrist.”
“By lowering local skin temperature, it helps the full body feel cooler in moments of sudden heat.”
It also works to counteract uncomfortable heat caused by hormonal changes or stress and anxiety.
Research in recent years has shown that almost four in 10 women in Ireland have considered quitting their jobs due to menopause symptoms.
Based in Bristol, England, O’Donovan studied mechanical engineering at the University of Limerick, which included a year in New York designing heating, ventilation and air conditioning systems for skyscrapers.
He went on to work at Dyson before moving into Formula 1 and aerospace engineering and has since applied design and thermodynamics principles to women’s health, working closely with hundreds of women to develop MyCelsius.
The bracelet has five different modes, including a night-time setting to prevent heat-induced sleep disruption.
MyCelsius worked with a community of women who were integral to shaping the product’s look, feel and functionality.
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