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.”
Smartwatch data may help track menopause sleep changes after researchers analysed more than 94,000 nights of Apple Watch sleep records.
The study analysed more than 94,000 nights of sleep data from 338 participants in the Apple Women’s Health Study.
It found that many participants spent more time awake during the night in the 12 months before and after their final logged menstrual period.
For the past several years, Apple has used the Apple Watch to support large-scale health studies through the Apple Research app.
These include the Apple Women’s Health Study, the Apple Heart and Movement Study, and the Apple Hearing Study, which launched in 2019 with research partners including Harvard, Brigham and Women’s Hospital, the American Heart Association and the University of Michigan.
In February 2025, Apple said those studies had grown to more than 350,000 participants across the US.
Recently, researchers at Harvard T.H. Chan School of Public Health published results on how sleep patterns change during perimenopause.
The study looked at wake after sleep onset, or WASO, which measures how much time a person spends awake after first falling asleep.
In the 18 months leading up to menopause, 60 per cent of women with sleep tracking data showed increased WASO compared with the previous six months.
The average increase was 7 per cent.
Researchers also found that, in the 12 months before and after the last logged menstrual period, participants spent about 0.8 per cent more of their sleep time awake after menopause than before.
However, the findings varied widely between participants.
Some women had much larger increases in time awake after menopause, while others had no meaningful sleep change at all.
The researchers said this reflects the fact that each person experiences perimenopause and menopause differently.
Participants who tracked sleep also logged menopause symptoms.
Hot flushes were reported by 82.3 per cent of participants, irritability by 68.1 per cent, mental exhaustion by 65.7 per cent and sexual symptoms by 65.6 per cent.
Among participants with more severe menopause symptoms, the symptoms most closely linked with worse sleep were bladder symptoms, joint symptoms, heart discomfort and depressive symptoms.
The researchers also shared recommendations that may help women sleep better during perimenopause.
These include maintaining a cool sleeping environment, keeping a consistent sleep schedule, getting regular movement, avoiding common bladder irritants and limiting fluids in the hours before bedtime, and prioritising relaxation or mindfulness techniques as part of a bedtime routine.
Women are still being failed by menopause care despite a surge in online advice, with experts saying symptoms are too often minimised or dismissed.
The researchers exposed a gap between the surge of menopause information available online and the quality of medical care women receive.
A team of anthropologists and psychologists explored the physical and emotional toll of menopause, including its impact on work and personal lives, through interviews with 60 women aged 45 to 61 between March and June 2021.
The findings were published in a new book, We Need to Talk About Menopause.
The interviews showed how women continue to “needlessly suffer” as they sort through misinformation from influencers, celebrities and so-called experts.
The authors said: “You would think in an age where humans are developing commercial space flight, self-driving cars, and AI personal assistants who can project movies onto the palm of your hand, we would understand more about menopause, something a little over half of the population is guaranteed to experience in their lives.”
The interviews revealed wide variation in women’s experiences of doctors.
Some felt they could have an open dialogue, while others said they were “shut down”, including being told they were too young for menopause.
One woman said she bled heavily for a year before she was taken seriously.
The authors said menopause is still poorly understood, with disagreement over whether it should be seen as a medical condition or a natural part of ageing.
There are more than 100 recognised symptoms, although some women experience none.
Among those interviewed, 78 per cent reported weight gain and redistribution, particularly around the belly area, which was resistant to diet and exercise.
Fifty-eight per cent experienced mood disturbances including anxiety, depression, irritability and unprecedented levels of rage.
Many women said they were blindsided by symptoms they had never known existed.
One participant said she only realised rage was a menopause symptom after seeing it mentioned in a television commercial.
Women also described severe memory problems and brain fog that colleagues mistook for incompetence, leading successful professionals to question their abilities at the peak of their careers.
Brain fog can include problems with concentration, memory and clear thinking.
According to Statistics Canada, 70 per cent of women turn to the internet as their primary source of menopause information.
The authors said this information vacuum has spawned a £14.7bn global “meno-tech” industry, with influencers, celebrities and telehealth companies offering products ranging from £98 creams to unnecessary blood tests.
They said: “The growth of interest in menopause has also been accompanied by a wave of unsubstantiated information.
“Many websites market expensive creams, supplements, and weight-loss schemes that promise to keep women youthful and attractive, with little evidence to support their claims.
“Reliable, accessible information about menopause and perimenopause is still lacking. Despite increased attention to the importance of physician training and the search for menopause specialists, the medical profession as a whole continues to provide limited support in this area.”
The authors also highlighted the effect of menopause in the workplace.
The House of Commons Women and Equalities Committee has warned that Britain is “haemorrhaging talent” because of menopause, with 14 million workdays lost each year, according to the Office for National Statistics.
Despite this, studies have shown 80 per cent of UK employers have yet to implement proper support measures for menopausal women.
Some women said simple workplace adjustments made a significant difference.
Sweden is exploring domestic production of oestrogen patches as shortages continue to disrupt menopause treatment.
Two government agencies have been asked to examine whether transdermal oestrogen patches could be made in the country.
Transdermal treatments deliver medicine through the skin, most commonly through patches, gels or sprays. They provide a continuous low dose of hormones.
The move follows a long-running shortage of oestrogen treatments that has left women struggling with menopause symptoms and forced pharmacists to look for alternatives.
Hot flushes, mood swings and depression are among the well-documented effects of menopause.
Jakob Forssmed, the health and social affairs minister, has asked the Swedish Medical Products Agency and the Dental and Pharmaceutical Benefits Agency to examine whether the patches could be produced in Sweden.
Speaking to Dagens Nyheter, Forssmed described the assignment as “very urgent”, citing recurring shortages affecting women who “need these medications to lead a functional life”.
The Swedish Medical Products Agency will examine whether a national operator could produce bulk transdermal formulations of oestrogen medicines and, where possible, prepare a process for production.
One possible manufacturer is the state-owned Apotek, Produktion & Laboratorier, which makes medicines tailored to the needs of the Swedish health system.
In 2025, about 205,000 women aged over 45 in Sweden were using systemic oestrogen treatment, according to a report from the Board of Health and Welfare.
That represents 8 per cent of women in the age group.
Transdermal oestrogen has become increasingly popular among menopausal women in Sweden. When patches are unavailable, some women switch to sprays and gels, which can then also run out of stock.
There is no shortage of oestrogen pills. However, experts say they are not a suitable option for everyone because of side effects that patches, sprays and gels do not have.
Angelica Lindén Hirschberg, professor of obstetrics and gynaecology at Karolinska Institutet, told Läkemedelsvärlden: “The pills affect the liver’s production of proteins and increase the risk of blood clots. For many women, the transdermal option, administered through the skin, is the only medically appropriate choice.”
Demand for hormone treatment has risen sharply in Sweden and globally, contributing to shortages.
Manufacturing constraints, supply chain bottlenecks and rising production costs are also said to play a role.
Läkemedelshandlarna, the Swedish association for parallel importers, has said access could be improved by allowing importers to buy hormone patches from other European countries at higher prices.
In response, representatives of the Swedish Medical Products Agency and the Dental and Pharmaceutical Benefits Agency said the causes of shortages needed to be seen “in a more nuanced light”.
They said: “The price level in Sweden is not the only explanation for the shortage of transdermal oestrogens, that is, oestrogen medications administered through the skin, most commonly via patches, gels, or sprays.
“Increased global demand and production issues are also affecting international supply.”
Estradot is among the oestrogen patches affected by shortages.
Some dosage strengths have been removed from Swedish benefit schemes by manufacturer Sandoz after authorities did not approve higher prices.
Under the government’s instruction, the Medical Products Agency will also consider whether access could be secured through EU mechanisms, including public procurement.
The Dental and Pharmaceutical Benefits Agency will examine whether more companies could hold marketing authorisations for transdermal oestrogen medicines, as well as whether parallel trade could be promoted.
The agencies are due to report back to the government by 30 October.
The Board of Health and Welfare report also found disparities in access to hormone patches across areas with different socioeconomic conditions.
In areas facing major socioeconomic challenges, 3.2 per cent of women collected hormone replacement therapy. In areas with very good socioeconomic conditions, the figure was 12.1 per cent.
Maja Österlund, an investigator at the agency, said: “These differences reflect a healthcare system that is currently unequal, and where we also know there is a shortage of certain medicines.”
Menopause1 week agoPerimenopause misinformation ‘putting women at risk’
Opinion4 weeks agoWhat Maternal Mental Health Month reveals about where postpartum support actually breaks down
News4 weeks agoNIH Grant terminations disproportionately impact minority scientists, research finds
Adolescent health4 weeks agoWUKA brings Period-Positive Pool Party to London Aquatics Centre to keep girls swimming through puberty
Insight3 weeks agoPCOS renamed after decade-long campaign to end ‘cyst’ misconception
Events4 weeks agoWHIS 2026 unveils agenda and first speakers for the leading women’s health summit
Mental health4 weeks agoCBT shows promise for menopause insomnia and hot flashes
Insight4 weeks agoOnline abuse and deepfakes ‘pushing women out of public life’
2 Comments