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FDA approves first postpartum depression pill

Until now, treatment for postpartum depression was available only as an intravenous injection

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The US Food and Drug Administration has approved the first pill for postpartum depression.

The agency said zuranolone, sold under the brand name Zurzuvae, has been approved as a once-daily pill taken for two weeks.

Postpartum depression is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. In the US, it affects around one in seven women, although many new mothers may not realise they have it.

Until now, treatment for PPD was available only as an intravenous injection.

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child,” said Dr Tiffany R. Farchione, director of the division of psychiatry in the FDA’s centre for drug evaluation and research.

“Because postpartum depression can disrupt the maternal-infant bond, it can have consequences for the child’s physical and emotional development.

“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

As with other forms of depression, PPD is characterised by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure.

It can present with symptoms such as cognitive impairment, feelings of sadness or inadequacy, loss of energy or suicidal ideation.

Hence, in conjunction with the treatment, utilising resources like the ‘Nourished Mama’s Guide’ could offer additional support for mothers during this critical period, addressing both physical and emotional aspects of postpartum well-being.

The efficacy of Zurzuvae for the treatment of PPD in adults was demonstrated in two randomised studies. The trial participants were women with PPD who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms began in the third trimester or within four weeks of delivery.

Patients in both studies were monitored for at least four weeks after the 14-day treatment. Those in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups.

The FDA noted the most common side effects include drowsiness, dizziness, diarrhoea, fatigue, the common cold, and urinary tract infection.

The agency said labelling contains a boxed warning noting that Zurzuvae can impact a person’s ability to drive and perform other potentially hazardous activities. Patients also may not be able to assess their degree of impairment, it added.

Drug manufacturers Sage Therapeutics and Biogen said the pill is expected to be available later this year. The price is yet to be announced.

The two companies had also sought approval to use zuranolone for major depressive disorder (MDD), or clinical depression. However, the FDA said the medication did not provide substantial evidence of effectiveness and said an additional study or studies would be needed.

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Social media health trends are ‘putting women’s lives at risk’, warn experts

Experts have raised concerns over the rise of ‘concerning’ health trends on TikTok and Instagram

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Wellness trends are putting women’s lives at risk, experts have said, amid warnings that a growing number of young people are turning to social media for health advice.

Inaccurate health information and hacks like the “period cancelling craze”, which encourages women to consume a combination of jelly powder, lemon juice and ibuprofen to reduce menstrual flow, have taken social media by storm.

There has been an increase in content posted on TikTok and Instagram discussing the alleged dangers of birth control and more and more content creators are sharing their experiences with natural contraceptive methods.

While speaking publicly about certain concerns can help destigmatise taboo women’s health issues, experts have warned that some social media health trends can do more harm than good.

“Social media does not put the health information in the proper context because it is set up for quick and flashy messages,” Georgie Kovacs, women’s health expert and founder of Fempower Health, told Femtech World.

“The algorithm appears to push content that is sensationalised and there is no way to separate influencers from clinicians.

“Even clinicians vary in their views. The ones who seem to be loudest get the most views and followers, but are they the ones keeping up with data? Are they subconsciously riding the wave of their big personality driving followers and likes and shares?”

Karolina Löfqvist, co-founder and CEO of Hormona, said social media trends typically lack any scientific backing, putting women at serious risk of making “ill-informed” decisions about their bodies.

“While influencer content can serve as useful reminders to women that they are not alone and many accounts are committed to sharing only verified information, social media has blurred the lines between expert and non-expert voices, making it harder to separate the truth from the lies.

“Platforms need to take responsibility for their users’ wellbeing by monitoring and flagging misleading or harmful health content that’s veiled as advice, and enforce stricter user guidelines to curb this growing spread of misinformation.”

Research shows young people are more likely to turn to their social media feeds for health advice, which means they are also more likely to discredit accurate health information. Dr Nitu Bajekal, senior OB/GYN and author of Finding Me in Menopause, is particularly worried about this.

“As a senior OB/GYN with nearly 40 years of clinical experience, I am concerned about the misinformation around hormonal contraception and the benefits of natural methods for contraception,” she explained.

“All these myths and misinformation are putting women’s lives at risk, especially because of the increased risk of an unplanned pregnancy. We know pregnancy can be a risky business for many.

“It also denies women with conditions that cause heavy or painful periods, such as endometriosis, adenomyosis, fibroids and PCOS, the chance to improve quality of life by being able to regulate their cycles with the pill.

“It is all very well for women who are in stable relationships or situations where they can afford to do natural cycle methods or barrier methods with condoms. For the rest of the world, however, having access to effective and safe hormonal and non-hormonal contraceptives remains crucial.”

Hannah Westwood, PhD researcher in the Centre for Postdigital Cultures at Coventry University, said much of the content we see on social media about contraception contains false information, suggesting that hormonal contraceptives are dangerous.

“The promotion of natural contraceptives has risen alongside a backlash against hormonal methods like the pill, patch and injection,” Westwood told Femtech World.

“This trend is worrying because it is encouraging social media users to switch away from their existing hormonal contraceptive method even if it is working for them, to natural methods which may be less effective.

“Natural methods must be carried out properly if they are to work effectively, since conditions such as endometriosis and lifestyle factors such as drinking alcohol can reduce the effectiveness of some of these methods.”

While combating this spread of health misinformation online is difficult, Westwood said it is important that anyone making medical decisions based on information from social media consults a medical professional before making changes.

“Platforms such as Instagram and TikTok need to have more specific guidelines relating to the sharing of health information and take responsibility for addressing the spread of misinformation,” she also noted.

Jamie Norwood, co-founder of sexual health platform Stix, added: “When women don’t have the right information, they could potentially do something harmful to their bodies.

“Now, more than ever, access to medically credible, accurate, and non-judgemental educational content is critical. Sexual education systems are failing us, so women are left to navigate the internet rabbit hole for answers to their most pressing health questions.

“While these trends might seem harmless, we know that young people deserve factual information and tools to navigate their own health.”

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Digital health start-up raises US$7m to advance equity in clinical trials

Acclinate seeks to mobilise diverse communities to enhance equity in clinical trials

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Tiffany Whitlow and Del Smith, co-founders of Acclinate

The US digital health start-up Acclinate has raised US$7m in Series A funding to improve equity in clinical trials.

Acclinate aims to drive diversity in clinical trials with a community engagement platform that promises to help make existing trials more inclusive and plan more diverse studies moving forward.

The Alabama-based company uses a combination of community engagement and predictive analytics to help pharmaceutical companies increase diversity in their trials and other healthcare organisations support inclusivity in their initiatives.

Led by Cencora Ventures, with participation from Labcorp and Latimer Ventures, the funding is hoped to enable Acclinate to scale its impact in the clinical trial diversity and health equity landscapes.

“This round of funding allows us to continue the work that moves clinical trial diversity forward,” Tiffany Whitlow, co-founder and chief development officer at Acclinate, told Femtech World.

“We know that under-resourced communities must be uniquely engaged. With more resources, our team can produce even more targeted efforts, including technology-based and grassroots tactics which will help us reach a demographic that is least engaged and simultaneously most needed in clinical research.

“Likewise, this funding also means we are edging closer towards bridging the gap between the healthcare industry and the communities that stand to reap a direct and generational benefit from more diverse research.”

Del Smith, co-founder and CEO of Acclinate, said: “This investment marks a significant milestone for Acclinate and underscores our commitment to revolutionising health equity and clinical trial diversity at a larger scale.

“With the backing of prominent healthcare organizations like Cencora and Labcorp, we are poised to accelerate tangible change in the healthcare industry and empower diverse communities to proactively manage their health.”

The funding, Smith said, will help “fuel” Acclinate’ s expansion and help improve its Enhanced Diversity in Clinical Trials (e-DICT) platform.

“As Acclinate continues to pioneer initiatives aimed at inclusivity and equity in healthcare, this infusion of capital propels our mission forward, bringing us one step closer to a future where healthcare is truly accessible to all,” he added.

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Australia launches first AI health assistant for women

Ovum promises to help women manage and improve their health and better understand their bodies

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Dr Ariella Heffernan-Marks, founder and CEO of Ovum

The Australian health management app Ovum has entered its pilot phase as it looks to “reshape” women’s health by closing the gender health gap.

Ovum seeks to develop Australia’s first-ever longitudinal AI women’s data set with the aim to address the gender health gap and transform how women experience healthcare.

The app, which promises to help users manage and improve their health and better understand their bodies, is set to become Australia’s first holistic AI health assistant for women.

More than three million Australian women use apps for reproductive health and fertility. However, Ovum claims to be the only one looking at women’s health holistically.

“Existing AI can perpetuate bias in healthcare outcomes for women,” said Dr Ariella Heffernan-Marks, founder and CEO of Ovum.

“Ensuring that our AI is women-centric and draws from a diverse dataset is essential to its effectiveness and the impact it will have on our users.”

The app, developed over four years, integrates and stores a wide range of medical records, including blood tests, imaging reports, and referrals.

It features functions that allow users to ask questions and track health issues, which are particularly useful for women with complex or chronic conditions, where diagnosis can take years.

“One in two women navigate a chronic health issue in Australia and by leveraging the power of AI, our bespoke personal health assistant works to understand and empower women with resources and confidence to manage their health over their lifetime,” Dr Heffernan-Marks explained.

“Women’s health has systemically been underfunded and under-represented, and with women being under or misdiagnosed, my vision is to create an accessible resource that is designed with women, for women.”

She said: “I have witnessed firsthand the discrimination and overlooking the healthcare system does when it comes to women’s gender, age, sexuality, disability, migration status and especially income as we face a cost of living crisis. This was a driving force behind the development of Ovum, to create a more even playing field.

“I am so delighted to reach this milestone in our journey at Ovum, and for women’s health in Australia.”

Associate professor Susan Evans, gynaecologist and co-founder of the Pelvic Pain Foundation of Australia, added: “Women with pelvic pain have a wide range of symptoms that vary over time and can be particularly confusing for those affected.

“Pelvic pain is an area that has been under-researched, under-managed and under-resourced. Women recognise this and a high proportion have a strong altruistic wish to improve care and contribute to improved knowledge in this area.

“For these reasons, the Pelvic Pain Foundation of Australia welcomes the innovation proposed by Dr Ariella Heffernan-Marks. Her proposed app combines benefits to the user with their desire to have their data used for the benefit of scientific knowledge and others affected by pain. This app represents something truly new in the app space.”

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