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HRT maker censured by regulators for ‘systemic failures’ that risked patient safety

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Theramex has been censured over HRT failures that regulators said jeopardised patient safety.

The UK producer of HRT drugs, including Evorel and Intrarosa, was found to have breached fundamental compliance standards.

These included not updating crucial prescribing information, in some cases for several years, and not making clear that one drug must not be used during pregnancy.

The Prescription Medicines Code of Practice Authority issued the public reprimand after Theramex staff blew the whistle over what it described as “alarming” compliance issues and incomplete prescribing information for Evorel and Intrarosa that “jeopardise patient safety”.

Evorel patches, which contain estradiol, are among the most prescribed forms of transdermal HRT, meaning hormone treatment delivered through the skin. More than 250,000 items were issued in the last financial year, according to NHS Business Services Authority figures.

Overall, nearly 10m items of estradiol, including gels, were prescribed in the 2024/25 financial year.

The employees’ concerns included failing to provide comprehensive side-effect information in Evorel’s prescribing information, and not updating Intrarosa’s product information since 2019.

The PMCPA also reprimanded the company over failures to specify in advertising at a reproduction and advertising conference that Yselty, used to treat uterine fibroids, should not be taken during pregnancy.

In total, the PMCPA found Theramex had breached the Association of the British Pharmaceutical Industry’s code of practice 21 times.

The panel said the breaches not only jeopardised patient safety, but that Theramex had “brought discredit upon, and reduced confidence in, the pharmaceutical industry”.

The PMCPA also condemned Theramex’s decision to leave the regulator’s jurisdiction.

“By leaving the self-regulatory framework and requiring the Medicines and Healthcare products Regulatory Agency to assume full responsibility for regulating it, Theramex has inevitably delayed any regulatory action and oversight,” it said.

Dr Amit Aggarwal, medical director of the ABPI, said: “Theramex has fallen seriously short of the standards expected under our strict ABPI code of practice, and it’s right that the PMCPA took action.

“It’s also disappointing that as a result, the company has decided to leave the pharmaceutical industry’s self-regulatory system, which holds companies to standards above and beyond the law.”

Julian Beach, MHRA’s executive director of healthcare quality and access, said he was disappointed Theramex had left the PMCPA, but that the MHRA would take any necessary steps to ensure patient safety.

He said: “Leaving the jurisdiction of the PMCPA does not mean a company escapes scrutiny.

“The MHRA has legal powers to investigate and act on concerns about medicines that may impact public safety. Breaches of regulations can amount to criminal offences.”

A spokesperson for Theramex said: “Upholding ethical standards, compliance, and patient safety is very important to us. We acted promptly to address these historical matters as soon as we became aware of them.

“We take these matters seriously and have undertaken a comprehensive review of our compliance framework, including commissioning an independent external audit and implementing a broad programme of enhancements.

“As part of this process, we concluded it is most appropriate to be regulated with respect to UK medicines legislation by the MHRA, while continuing to uphold the spirit and principles of the EFPIA and ABPI codes of practice.

“Therefore, we withdrew from the PMCPA’s jurisdiction in January 2026. This approach allows us to focus our resources on maintaining high standards of ethical and compliant behaviour, with patient safety.”

Motherhood

Expectations about sleep affect postpartum sleep quality, study finds

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Pregnant women’s expectations about postpartum sleep may predict sleep quality after birth, outweighing prior sleep and psychiatric history, a study suggests.

The findings suggest attitudes and beliefs about sleep during pregnancy could be a modifiable risk factor for postpartum sleep concerns.

They also indicate that, among women expecting the poorest sleep, higher postpartum anxiety may further worsen sleep quality.

Sammy Dhaliwal, lead author is clinical health psychologist and research fellow in the department of obstetrics and gynaecology at the Perelman School of Medicine at the University of Pennsylvania.

Dhaliwal said: “Most pregnant women in our sample anticipated poor postpartum sleep before it occurred, and it was striking that those expectations predicted worse sleep outcomes even after accounting for factors such as prior sleep disorders, psychiatric history, and number of previous births.

“This suggests that attitudes and beliefs about sleep during pregnancy may represent a modifiable target for early intervention before postpartum sleep problems emerge.”

Sleep disturbance affects an estimated 60 to 80 per cent of postpartum women and is linked to a higher risk of depression and anxiety.

Researchers said it is often regarded as an expected part of life after childbirth rather than a health issue that may be addressed earlier.

The study enrolled 432 pregnant women at about 24 weeks of gestation, meaning around 24 weeks into pregnancy.

Participants completed measures of their expectations about postpartum sleep, current sleep quality using the Pittsburgh Sleep Quality Index, and mood using validated depression and anxiety scales.

Assessments were repeated at six, 12 and 24 weeks postpartum.

A subset of 49 women also wore wrist actigraphy devices at six to eight weeks postpartum.

Actigraphy uses a wearable device, similar to a watch, to estimate sleep and wake patterns based on movement.

The results showed that 70 per cent of pregnant women, or 301 of 432 participants, expected poor sleep in the postpartum period.

Researchers found that predicted sleep disruption during pregnancy was a significant predictor of postpartum sleep concerns.

Among first-time pregnant women without prior health concerns, those who expected greater sleep disturbance had significantly more disrupted sleep after birth, measured by both actigraphy and self-report.

Among women who expected the worst sleep quality, higher postpartum anxiety significantly worsened both measured sleep and self-reported sleep, independent of anxiety levels during pregnancy.

Dhaliwal said the findings point to two possible areas for intervention: addressing sleep-related beliefs during pregnancy and treating postpartum anxiety.

Dhaliwal said: “Postpartum sleep disruption is often treated only after problems develop, but our findings suggest there may be an opportunity to intervene earlier during pregnancy.

“Addressing sleep-related beliefs and postpartum anxiety during prenatal and postpartum care may help improve sleep and emotional well-being in new mothers.”

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Fertility

Weight loss jab shows early promise in improving PMOS fertility

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A weight loss jab may improve fertility outcomes in women with PMOS, early findings from an ongoing clinical trial suggest.

The proof-of-concept analysis found that injectable semaglutide may offer reproductive benefits while also addressing obesity and metabolic dysfunction.

It is the first report to examine how injectable semaglutide may improve reproductive outcomes in women with PMOS while also addressing obesity and metabolic dysfunction.

The work forms part of the ongoing RESTORE clinical trial.

Melanie Cree, professor at CU Anschutz and first author of the report, said: “Women with PMOS frequently face a frustrating choice between treatments that target reproductive symptoms and those that address metabolic health.

“Our early findings suggest injectable semaglutide may have the potential to improve both, offering a more comprehensive approach to care.

“This medication is incredibly promising when someone responds with 10 per cent weight loss.”

The trial is examining whether semaglutide can restore ovulation and improve reproductive health in adolescents and adults with polyendocrine metabolic ovarian syndrome, known as PMOS.

PMOS, formerly known as polycystic ovary syndrome or PCOS, is a hormone and metabolic condition linked to irregular periods, raised testosterone levels, infertility risk, obesity and increased cardiometabolic disease.

Cardiometabolic disease refers to conditions linked to the heart and metabolism, such as heart disease, high blood pressure and type 2 diabetes.

Existing treatments, including metformin and hormonal contraceptives, often do not fully address reproductive and metabolic complications at the same time.

The analysis focused on participants aged 12 to 35 who lost at least 10 per cent of their body weight during treatment.

Researchers said reproductive improvements appeared earlier than expected, prompting them to report preliminary findings while the wider study continues.

Cree is also a paediatric endocrinologist at Children’s Hospital Colorado.

Endocrinologists are doctors who specialise in hormones and hormone-related conditions.

Cree said: “What makes this work particularly important is that it focuses specifically on women with PMOS receiving injectable semaglutide.

“Although GLP-1 medications have transformed obesity treatment, there remains a significant need for rigorous data examining how these therapies affect fertility and reproductive function in this population.”

The RESTORE study is evaluating semaglutide treatment in girls and women with PMOS and obesity.

Its broader aim is to determine whether weight loss and metabolic improvements can restore ovulation and improve reproductive outcomes.

Ovulation is the release of an egg from the ovary, a key part of the menstrual cycle and fertility.

The authors said the findings are from an early proof-of-concept analysis and that larger, longer-term studies will be needed to confirm whether the reproductive benefits last.

The findings suggest injectable semaglutide may become a treatment option for women with PMOS seeking improvements in both metabolic and reproductive health, if future studies confirm the results.

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Entrepreneur

Women’s Health Week Europe 2026 opens pitch applications for mainstage showcase at The Emirates Stadium

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Women’s Health Week Europe 2026 has opened applications for its flagship start-up Pitches, giving women’s health innovators the chance to present on the mainstage at The Emirates Stadium in London on 7-8 October.

16 finalists will be selected across two categories: Medical Devices & Therapeutics and Consumer & Tech, with the shortlisted companies receiving the opportunity to pitch in front of 700+ investors, corporates, other innovators and strategic partners actively seeking solutions that can scale.

Two categories, one stage

The Medical Devices & Therapeutics category is open to companies working across medical devices, therapeutics and pharma innovation, regulated digital health, and deep-tech or science-led platforms.

The Consumer & Tech category covers consumer health and wellness brands, digital health platforms, wearables and connected data, employer and payor-led solutions, and commerce and marketplace businesses.

Any company treating a condition that affects women exclusively, differently, or disproportionately is eligible to apply.

Applications are completely free, so what do you have to lose?

Apply to pitch at WHW Europe 2026 now.

What’s in it for you?

Unmatched exposure

Present in front of 700+ investors, corporates, clinicians, and strategic partners actively seeking solutions that can scale.

With WHW Europe 2026 relocating to The Emirates Stadium and expanding to 700+ attendees across two stages, the 2026 edition represents the largest platform the series has offered to date.

A proven platform

The WHW Pitch Sessions have become one of the most commercially significant showcases in women’s health, with previous cohorts including companies that have gone on to raise investment and secure major strategic partnerships. 2024 alumni BoobyBiome, closed a £2.5M seed round in the year following their pitch at WHW Europe.

The Watchlist

All registered applicants will have the opportunity to be featured in The Watchlist, WHW Europe’s official directory of women’s health innovators to know, giving companies visibility beyond the pitch stage itself.

Applications close 28 August 2026.

Find out more about WHW Europe.

Apply to pitch at WHW Europe.

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