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Hormonal health

FDA removes warning label from menopause drugs

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The FDA will remove the menopause drug warning from hormone therapies, citing updated evidence on stroke and heart risks.

US health officials said Monday they will drop the boxed warning — the strongest safety alert on a drug label — from more than 20 pills, patches and creams with hormones such as oestrogen and progestin, used to ease hot flushes and night sweats.

The 22-year-old warning told doctors that hormone therapy raises the risk of blood clots, heart problems and other issues, based on an influential study published more than 20 years ago.

FDA commissioner Marty Makary called the current label outdated and unnecessary. Officials pointed to studies suggesting hormone therapy carries few risks when started before age 60 and within 10 years of symptoms beginning.

Health secretary Robert F. Kennedy Jr. said: “We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts.”

Medical guidelines generally advise limited-duration use in younger women going through the menopause who do not have complicating risks, such as breast cancer.

The FDA’s updated prescribing information largely aligns with that approach.

Makary and some other doctors have argued that benefits may extend beyond symptom relief.

Before becoming FDA commissioner, Makary devoted a chapter of his latest book to what he described as the overall benefits of hormone therapy and criticised doctors unwilling to prescribe it.

On Monday he repeated that view, citing figures suggesting hormone therapy reduces heart disease, Alzheimer’s and other age-related conditions.

Makary told reporters: “With few exceptions, there may be no other medication in the modern era that can improve the health outcomes of women at a population level more than hormone replacement therapy.”

The scale of those benefits remains under study. Dr JoAnn Manson of Harvard Medical School said the evidence for overall health benefits is not “as conclusive or definitive” as Makary suggested.

Still, she said removing the warning could help doctors and patients make more personalised decisions.

Manson said: “The black box is really one size fits all. It scares everyone away. Without the black box warning there may be more focus on the actual findings, how they differ by age and underlying health factors.”

In the 1990s, more than one in four US women took oestrogen alone or with progestin, amid assumptions it would cut rates of heart disease, dementia and other problems, as well as treat symptoms.

But a landmark study of more than 26,000 women challenged that, linking two hormone pill types to higher rates of stroke, blood clots, breast cancer and other serious risks.

After the 2002 findings were published, prescriptions fell across age groups.

Makary said: “That study was misrepresented and created a fear machine that lingers to this day.”

A new analysis of the 2002 data, published in September, found women in their 50s on oestrogen-based drugs had no increased risk of heart problems, while women in their 70s did; the data for women in their 60s was unclear.

Since the early 2000s, newer forms have arrived, including vaginal creams and tablets that deliver lower doses than pills and patches.

The original warning language will still be available to prescribers but placed lower on the label.

he drugs will keep a boxed warning that women who have not had a hysterectomy (surgical removal of the uterus) should take a combination of oestrogen-progestin due to the risk of cancer in the uterine lining.

Rather than convening one of the FDA’s standing advisory committees on women’s health or drug safety, Makary earlier this year invited a dozen doctors and researchers who overwhelmingly supported the health benefits of hormone-replacement drugs.

Many of the panellists at the July meeting consult for drugmakers or prescribe the medicines in private practice. Two of the experts also spoke at Monday’s FDA news conference.

Asked on Monday why the FDA did not convene a formal advisory panel, Makary said such meetings are “bureaucratic, long, often conflicted and very expensive.”

Diana Zuckerman of the non-profit National Centre for Health Research accused Makary of undermining the FDA’s credibility by announcing the change “rather than having scientists scrutinise the research at an FDA scientific meeting.”

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Hormonal health

Immune cells linked to longer-lasting pain in women

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Differences in immune cells may explain why chronic pain lasts longer in women than men, according to new research.

The study identified a subset of monocytes, a type of white blood cell, that release interleukin-10, or IL-10, a molecule that signals pain-sensing nerves to switch off pain. These cells were found to be more active in males, linked to higher levels of sex hormones such as testosterone.

Females experienced longer-lasting pain and slower recovery because their monocytes were less active. The same pattern was observed in both mouse models and human patients.

Researchers first detected unexpectedly higher levels of IL-10 in males during a small pilot project. When a second test confirmed the finding, they used high-dimensional spectral flow cytometry, a laboratory technique that allows detailed analysis of immune cells, to investigate further. Blocking male sex hormones produced the opposite effect.

Geoffroy Laumet, associate professor of physiology at Michigan State University, said: “The difference in pain between men and women has a biological basis. It’s not in your head, and you’re not soft. It’s in your immune system.”

Pain occurs when specialised neurons throughout the body respond to stimulation. In people with chronic pain, these sensors can be activated by mild stimulation or even none at all. Doctors often rely on patients rating pain on a scale of one to 10, and when more women report persistent pain, the difference has often been attributed to perception or reporting rather than biology.

The team carried out at least five types of tests in mouse models to confirm the findings. They then worked with Sarah Linnsteadt at the University of North Carolina at Chapel Hill, who was studying psychological outcomes in people involved in car accidents. Her research showed a similar pattern, with men having more active IL-10-producing monocytes and resolving pain faster.

Jaewon Sim, a former graduate student in Laumet’s laboratory, said: “I feel extremely fortunate that we trusted those early, uncertain findings and chose to pursue them further.”

Laumet said: “This study shows that pain resolution is not a passive process. It is an active, immune-driven one.”

The findings shift attention from how pain begins to why it persists. The next step is to investigate whether treatments could target this pathway and boost IL-10 production. While any new treatment is likely to be decades away, the research could eventually support non-opioid approaches to managing chronic pain.

“Future researchers can build on this work,” Laumet said. “This opens new avenues for non-opioid therapies aimed at preventing chronic pain before it’s established.”

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Heavy or light periods may signal fertility risk

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Very heavy or very light periods may be linked to underlying health problems that affect quality of life and can influence fertility, according to medical experts.

Heavy menstrual bleeding is reported to have a major impact on daily life, with around two thirds of affected women seeking medical help. Beyond anaemia, which can cause fatigue, dizziness, pallor and a rapid heartbeat, heavy bleeding can lead to social and practical difficulties such as stained clothing, higher use of menstrual products and work limitations.

Doctors stress that the amount of bleeding itself does not directly affect fertility. Instead, abnormal bleeding can reflect underlying conditions, some of which can make it harder to become pregnant.

Raúl Villasevil, a specialist in obstetrics and gynaecology at San Carlos Clinical Hospital in Madrid, Spain, said: “The most frequent causes of heavy periods are polyps, fibroids, adenomyosis, some malignant tumours, ovulatory and coagulation problems, endometrial disorders, and certain medications.”

Very light periods can also signal problems, including uterine malformations, intrauterine adhesions, where scar tissue forms inside the womb, and anatomical abnormalities of the vagina. They may also point to ovulatory and hormonal disorders such as hyperprolactinaemia, which involves excess production of the hormone prolactin, or polycystic ovary syndrome. Once confirmed, these conditions can lead to symptoms including infertility.

To identify the cause of abnormal bleeding, Villasevil said doctors begin with a detailed personal and gynaecological history, followed by a physical examination and usually an ultrasound to assess the uterus and ovaries. Blood tests are also used to check for anaemia, coagulation status and hormonal function.

“This basic evaluation is often sufficient to establish the cause of the bleeding abnormality and to propose solutions. If this basic workup does not identify the cause, additional tests such as hysteroscopy or magnetic resonance imaging can be performed,” he added.

Hysteroscopy involves inserting a small camera into the womb to examine it from the inside.

In most cases, the cause of menstrual abnormalities can be identified and treated. A range of treatments allow a personalised approach for each woman, taking into account whether she wishes to have children, her age and her individual needs at different stages of life.

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Hormonal health

Endometriosis-sufferer wins landmark tribunal case on workplace discrimination

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A former Accenture employee has won an appeal tribunal ruling after a judge said her endometriosis may amount to a disability under the Equality Act 2010.

A senior employment law judge last month quashed a 2022 tribunal decision that rejected claims brought by Sanju Pal, 43, against the consulting firm.

The judge found the original ruling did not properly consider whether Pal’s endometriosis, a condition where tissue similar to the womb lining grows elsewhere and can cause chronic pain, amounted to a disability under the Equality Act 2010.

The decision also said the ruling mischaracterised her reasons for dismissal and lacked evidence for some claims.

Pal has previously described how Accenture terminated her contract in 2019 despite her having a “cyst the size of a Coke can” on one of her ovaries, in what was a severe and chronic case of the condition.

For Pal, however, the fight is not over. The judgement ordered a fresh employment tribunal to reconsider her claims, and Accenture reserves the right to appeal.

The case has drawn attention since the appeal decision, with Pal appearing on BBC News and Radio as well as ITV News.

Pal said: “Whilst my faith was shaken after the initial employment tribunal, this judgement has restored it somewhat.

“Luckily, I got an appeals judge who finally heard me.

“A line one of my close friends said was ‘the system failed Pal’. Oh my God, just to hear and see that.”

She added: “I’m not surprised my case is making waves in the media, as there is no other case in the UK that has gone to this level of court, for a respondent that refused to concede.

“Of course it’s going to gain traction now, and I think women are absolutely outraged that this could be possible.”

Emma Cox, head of Endometriosis UK, suggested on BBC Radio 5 Live that Pal’s case will make a “real difference”.

She said: “It yet again highlights that endometriosis and its impact are not properly understood in the workplace, and the appeal ruling makes it quite clear that those living with endometriosis may be protected, and it should be considered.

“I also hope it gives a push to our campaigns, one of the things we are pushing for is to have menstrual health included in the employment’s rights act.”

Pal, who also referenced a government petition to introduce menstrual leave for those with endometriosis and adenomyosis, a related condition where tissue grows into the muscular wall of the womb, due to be debated in parliament, said far more needs to be done to acknowledge the reality of workplace discrimination.

She commented: “Those with endometriosis are hearing from their employer: ‘What do you mean you can’t come into work? What do you mean you can’t do this shift’? Or ‘what do you mean that you need to take time off for X, Y and Z?’

“It’s happening every day across this country to millions of women, and that’s just endometriosis before you start talking about other conditions.”

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