News
FDA approves first over-the-counter birth control pill
Opill may help reduce the number of unintended pregnancies and reduce barriers to accessing contraceptives

The US Food and Drug Administration has approved the country’s first-ever daily hormonal contraceptive pill for sale without a prescription in a move that could dramatically change access to birth control.
Opill, the progestin-only pill from drugmaker Perrigo, will provide an option for obtaining oral contraceptives without needing to first see a healthcare provider, in hopes of reducing barriers to access.
Almost half of the over six million pregnancies in the US each year are unintended, according to the FDA’s news release.
Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes.
Availability of nonprescription Opill, the FDA said, may help reduce the number of unintended pregnancies and their potential negative impacts.
“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Dr Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
“When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
The contraceptive efficacy of Opill (norgestrel) was established with the original approval for prescription use in 1973. HRA Pharma applied to switch norgestrel from a prescription to an over-the-counter product.
For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional.
Studies showed that consumer understanding of information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an over-the-counter product.
The FDA concluded Opill is “safe and effective” when used properly. The guidelines include taking the pill at the same time every day; not using it along with another hormonal birth control product, including intra-uterine devices (IUDs); and avoiding medications that interact with it.
However, the agency warned Opill should not be used by those who have or have ever had breast cancer.
“Consumers who have any other form of cancer should ask a doctor before use,” it added.
The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating.
Use of Opill may also be associated with changes in vaginal bleeding patterns, such as irregular spotting and prolonged bleeding.
The pill is expected to go on sale at major retailers early next year with no age restrictions on sales.
Fertility & pregnancy
Xella Health announces Oura data integration

Xella Health has integrated Oura wearable data into its women’s health platform, allowing members to share trends with clinicians alongside diagnostic results.
Members can choose to share information including sleep, heart rate variability, resting heart rate, temperature trends, recovery, activity and menstrual-cycle data.
The integration is intended to help clinicians investigate biological factors that may explain changes in members’ wearable data and symptoms.
Kelly Lacob, chief executive and co-founder of Xella Health, said: “Wearables detect that something in the body has changed, but wearable data alone can’t tell a woman why or what to do next with that information.”
“By pairing continuous physiological monitoring from Oura with Xella’s multiomic diagnostics and physician-guided care, we enable women to understand how specific health concerns are impacting her biometrics, and vice versa how her daily habits are impacting her overall health and specific conditions or life stages she is navigating.
“Further, we are able to track how her relevant vitals and biometrics respond to specific interventions or treatment plans, so we can optimise her care more efficiently.
“Ultimately, this partnership helps us better address her symptoms today whilst also proactively optimising her long-term health trajectory for decades to come.”
Xella Health combines AI, multiomic testing and physician-guided telehealth care through a membership platform.
Multiomic testing analyses several types of biological information.
Xella said its testing assesses hormonal and metabolic health, inflammation, nutritional status, reproductive health and cardiometabolic risk.
Physicians use those findings to develop personalised care plans that may include clinical treatments.
Clinicians can then review shared Oura trends alongside diagnostic results and member check-ins to monitor progress and adjust care over time.
The company said providers interpret biometric data in the context of each member’s health conditions, goals and treatment plan.
The integration focuses on fertility, perimenopause, hormonal and cardiometabolic health, as well as women’s longer-term health.
Oura has expanded its women’s health offerings through integrations connecting wearable measurements with other sources of health data.
In February, it partnered with at-home hormone tracking company Mira, allowing users to view hormone test results alongside sleep, temperature and readiness data in the Mira app.
The integration is intended to help users track patterns related to fertility, menstrual cycles and perimenopause.
That month, Oura also introduced a women’s health AI model for testing through Oura Labs.
Integrated into Oura Advisor, the model combines biometric data with clinician-reviewed medical information to provide guidance on menstrual cycles, pregnancy and menopause.
In May, the company launched menopause insights and hormonal birth control support.
Its Menopause Insights offering uses a questionnaire covering 22 symptoms of menopause alongside wearable data, while birth control support helps users understand their biometric trends in the context of hormonal contraception.
Menopause
Tech enables men to experience what a hot flush feels like

Partners of women going through menopause will be invited to experience hot flushes using a menopause simulator at a support event in Hull next month.
Health group Over The Bloody Moon will bring one of its MenoVests to the Menopaus’ull Support Network event, allowing people to experience a hot flush.
Sarah Weichardt, who co-manages the project, said: “We’re particularly interested in getting men along to come and experience the MenoVest, just so that they can understand what women go through.
“It’s not just a hot flush, it’s what the hot flush brings with it.
“So it could be panic, it could be anxiety. It’s experiencing it all at the same time.”
MenoVest is billed as the ‘world’s first’ wearable menopause simulator – a garment worn over regular clothing that generates realistic, intense hot flush sensations while the wearer carries on with everyday work tasks.
After just a few minutes wearing it, people gain a genuine sense of what these symptoms feel like, building empathy and highlighting why better support matters during this transition.
Weichardt said she hoped the vest would give people a “better understanding of what women are going through”.
“The more people we can get to experience it, the better,” she added.
Menopause
Short term HRT may raise blood clot risk – study

Short-term oral HRT was linked to a 60 per cent higher rate of serious blood clots in women aged 50 to 69, a large study found.
The increased rate was seen among women using oral hormone replacement therapy for less than a year as well as those treated for more than five years.
By contrast, transdermal HRT, delivered through skin patches, gels or sprays, was not associated with the same increased clot risk.
Researchers at North Zealand Hospital in Denmark analysed health registry data from more than one million Danish women aged 50 to 69 between 2003 and 2021.
During the study period, 9,807 women experienced venous thromboembolism, a serious blood clot in a vein. A further 18,460 had a stroke and 11,974 had a heart attack.
Each affected woman was matched by age with five women who had not experienced the same condition. Researchers adjusted the analysis for other factors, including medical history, that could influence risk.
They then examined HRT prescriptions, including the dose and duration of treatment, and looked for associations with blood clots, stroke and heart attack.
Overall, oral HRT was associated with a 60 per cent higher rate of venous thromboembolism, with increased rates seen for both oestrogen-only therapy and treatment combining oestrogen with progestogen.
Venous thromboembolism occurs when a blood clot forms in a vein. A clot in a deep vein can break away and travel to the lungs, causing a potentially fatal pulmonary embolism.
Women taking oral HRT for less than a year had the same raised blood clot risk as those using it for more than five years.
Even a daily oral dose below 1mg was found to significantly increase blood clot risk.
Women taking a daily oral dose above 1mg for more than five years had an 80 per cent higher risk of both heart attack and stroke.
For women taking a high oral dose for more than one year, the study found a 40 per cent higher risk of heart attack and a 50 per cent higher risk of stroke.
The researchers highlighted the importance of choosing the type, dose and duration of treatment carefully, particularly for patients vulnerable to blood clots.
Dr Robert Storey, professor of cardiology at the University of Sheffield, who was not involved in the research, said the findings demonstrated the importance of ensuring cardiovascular risk factors were “well controlled” in women taking oral HRT.
He added: “The study emphasises the superior safety of patches over oral treatment.”
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