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FDA approves first over-the-counter birth control pill

Opill may help reduce the number of unintended pregnancies and reduce barriers to accessing contraceptives

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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.

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Taking charge of your well-being: A guide to pelvic health

By Gloria Kolb, Co-founder & CEO – Elitone

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Pelvic health is a vital yet often overlooked aspect of overall well-being. It encompasses the proper functioning of the muscles, ligaments, and tissues that support the pelvic organs and plays a critical role in daily activities and quality of life. 

Despite its importance, pelvic health remains shrouded in silence and stigma.

Many people hesitate to discuss issues like incontinence, pelvic pain, sexual health concerns, and pelvic organ prolapse due to societal taboos and misconceptions.

This reluctance to talk openly can lead to prolonged suffering and a diminished sense of well-being.

By shedding light on the various aspects of pelvic health, we aim to break the taboo, educate on everyday issues, and empower individuals to take proactive steps in managing their pelvic health.

Understanding the significance of pelvic health and addressing problems early can lead to a more vibrant, healthy, and fulfilling life.

Understanding pelvic health

Pelvic health refers to the optimal functioning of the pelvic floor, which forms a supportive base for the pelvic organs, including the bladder, uterus, and rectum.

These muscles play a crucial role in urinary and faecal continence, sexual function, and support during physical activities.

The pelvic floor acts like a hammock, providing stability and support to the pelvic organs.

When these muscles are strong and functioning correctly, they help maintain proper organ positioning and function.

However, various factors such as aging, childbirth, surgery, obesity, and chronic straining can weaken or damage the pelvic floor muscles, leading to a range of health issues.

The importance of pelvic health

Neglecting pelvic health can lead to various complications, from mild discomfort to severe disruptions in daily activities.

For instance, incontinence can result in social embarrassment and a reluctance to engage in physical activities, while chronic pelvic pain can interfere with work, exercise, and personal relationships.

Sexual health issues related to pelvic floor dysfunction can affect intimacy and emotional connection with partners.

The long-term consequences of ignoring pelvic health can be profound, leading to chronic pain, mental health struggles, and decreased independence.

Early intervention and proactive management of pelvic health are essential for preventing these outcomes and promoting overall well-being.

Recognising the importance of pelvic health empowers individuals to seek appropriate care and take steps to maintain or restore their pelvic floor function, ultimately enhancing their quality of life.

Common pelvic health issues

Understanding the common issues that affect pelvic health is crucial for recognising symptoms early and seeking appropriate care. Some of the most prevalent pelvic health problems include:

  • Incontinence: This refers to the involuntary leakage of urine or faeces. Different types include stress, urge, overflow, and functional incontinence. Causes range from weakened pelvic floor muscles to nerve damage and underlying health conditions.
  • Pelvic pain: This discomfort in the lower abdomen and pelvic region can be brought on by chronic conditions like endometriosis and interstitial cystitis. Acute issues such as infections or injuries can cause persistent pain, impacting daily activities and emotional well-being.
  • Sexual health concerns: These include dyspareunia (painful intercourse), decreased libido, and erectile dysfunction. Causes can be hormonal, muscular, or psychological. Addressing these concerns is vital for maintaining intimacy and relationship satisfaction.
  • Pelvic organ prolapse: This occurs when the pelvic organs descend and fall out of place, with common causes including childbirth, aging, and obesity. Symptoms range from heaviness in the pelvic area and discomfort sitting down to urinary and bowel dysfunction. Early intervention is essential for managing symptoms.

Understanding and addressing these common pelvic health issues is vital for improving quality of life and overall well-being.

Awareness, open communication, and timely medical intervention can help manage these conditions effectively, empowering individuals to lead healthier, more fulfilling lives.

Diagnosis and treatment options

Pelvic health issues are typically diagnosed through routine pelvic examinations, which assess the position and support of pelvic organs and can identify problems such as prolapse and muscle weakness.

Imaging tests, including ultrasound, MRI, and CT scans, provide detailed images of the pelvic area, helping to diagnose structural problems and guide treatment plans.

Additionally, questionnaires and symptom checklists assist healthcare providers in understanding the severity and impact of symptoms on daily life, aiding in accurate diagnosis.

Treatment options for pelvic health issues fall into two main categories: conservative measures and medical interventions.

Conservative measures often serve as the first line of defence.

Lifestyle modifications, such as diet changes, bladder training, weight management, and avoiding heavy lifting, can alleviate symptoms.

Pelvic floor physical therapy, involving exercises designed to strengthen the pelvic floor muscles, can improve function and reduce symptoms.

Non-surgical devices, like pessaries and stimulation, can help manage prolapse and incontinence without the need for surgery. 

When conservative measures are insufficient, medical interventions may be necessary to help manage pain, inflammation, and symptoms of incontinence or prolapse.

Minimally invasive procedures such as injections or medication may offer relief for various pelvic health issues.

In severe cases, surgical options like pelvic floor reconstruction and sling procedures for incontinence or prolapse may be required.

It is crucial to carefully weigh the risks and benefits of surgery with a healthcare provider. 

Treatment should be tailored to each person’s specific condition, symptoms, lifestyle, and preferences.

However, it is key to note that more medical interventions may not be more productive than conservative ones.

Holistic approaches to pelvic health

Adopting holistic approaches to pelvic health can significantly enhance overall well-being by addressing physical, mental, and emotional aspects.

Regular exercise, particularly pelvic floor exercises like Kegels, strengthens these muscles, while whole-body activities such as yoga and Pilates improve core strength and flexibility to support pelvic health.

Specific yoga poses like Bridge Pose and Goddess Pose target the pelvic floor, while mindfulness practices reduce stress.

Nutrition is also vital. A fibre-rich diet prevents constipation, which reduces pelvic strain, while hydration helps maintain urinary health, and anti-inflammatory foods help manage pelvic pain.

Protein can help build the needed pelvic muscles.

Alternative adjunct therapies, including acupuncture, chiropractic care, and biofeedback, can complement traditional treatments in alleviating pain, improving muscle function, and enhancing overall pelvic health.

Integrating these holistic methods fosters a balanced approach to maintaining and improving pelvic health, leading to a healthier, more fulfilling life.

Breaking the taboo and empowering yourself

Breaking the taboo surrounding pelvic health is essential for empowering individuals to take charge of their well-being.

Societal stigma often discourages open discussions about pelvic health issues, leaving many people feeling isolated and ashamed of their experiences.

By normalizing conversations about pelvic health, individuals can overcome this stigma and access the support and resources they need.

Empowering oneself to take charge of pelvic health begins with education and awareness.

Understanding the signs and symptoms of pelvic health issues allows individuals to recognise when they need help and seek appropriate care.

Open communication with healthcare providers is crucial for discussing concerns and developing personalised treatment plans.

Additionally, joining support groups or seeking guidance from mental health professionals can provide valuable emotional support and validation.

By embracing a proactive approach to pelvic health and advocating for their own well-being, individuals can reclaim control over their bodies and lives.

By fostering a culture of openness and support, we can break down barriers and ensure everyone feels empowered to prioritise their pelvic health and live their lives to the fullest.

Gloria Kolb is the CEO and co-founder of Elitone, an FDA-cleared, non-invasive wearable treatment for women with urinary incontinence. Elitone has won “Best New Product” by My Face My Body awards, Sling Shot 2020, and numerous startup pitch awards.

As an inventor with 30  patents, Gloria’s accolades include being featured in Forbes as a Top Scientist Driving Innovation in Women’s Health.

Her creative designs and problem-solving abilities have earned her recognition, such as Boston’s “40 Under 40” Award and MIT Review’s “World’s Top Innovators under 35”.

With Mechanical Engineering degrees from MIT and Stanford and an Entrepreneurship MBA from Babson College, Gloria’s expertise extends to consulting, where she evaluates technology and clinical markets for various inventions and startups.

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ProgenyHealth expands partnership to improve maternal health

The partnership aims to “personalise” maternity and NICU care management through a whole-person approach

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Ellen Stang, ProgenyHealth founder and executive chairwoman and Susan Torroella, ProgenyHealth CEO

The healthcare company ProgenyHealth has expanded its partnership with the women’s health solutions company Wildflower Health to improve maternal health outcomes.

The collaboration aims to break down “existing silos” and help health plans move faster to improve maternal and infant health outcomes.

ProgenyHealth is on a mission to transform NICU care management driving towards better outcomes and lower total costs for babies that experience a NICU stay.

The company’s maternity programme covers the time period from conception and pregnancy to postpartum and parenting with special expertise in managing premature and complex births and resulting NICU admissions.

By extending its reach to prenatal care management several years ago, ProgenyHealth says it was able to both improve maternal health and target NICU prevention.

The company turned to Wildflower Health to advance its mission.

“We have been working with Wildflower Health over these past few years  to provide integrated solutions to moms throughout their entire pregnancy journey,” said Susan Torroella, CEO at ProgenyHealth.

“While digital tools and consumer apps are not new to the world of healthcare, we are taking a uniquely cooperative approach to member-facing technology that positively affects enrollment, engagement, and health plan member impact.

“In a time when it is important for health plans to continually differentiate their work and value, our ongoing collaboration with Wildflower does just that. Together, we believe it is our responsibility to provide the best technology solutions along with the most compassionate human connection.”

The partnership, Torroella said, seeks to “personalise” maternity and NICU care management through a whole-person approach.

Leah Sparks, founder and CEO, Wildflower, said: “Wildflower’s overall solutions comprehensively address access, cost, outcomes and experience throughout women’s health.

“Our strategic partnership with ProgenyHealth seamlessly helps health plans fill gaps, collapse silos and integrate into existing clinical and operational workflows.

“When it comes to maternal health, early identification coupled with timely member engagement drives momentum and improves care. Our goal is to always support the whole person by helping address the clinical and social determinants of health (SDOH) needs of members and their families.”

The healthcare challenges facing women in the US, particularly when it comes to giving birth, are growing. While maternal mortality rates have more than doubled since 2000, a majority of these deaths are preventable.

To improve in this regard, ProgenyHealth believes the industry must strive to remove “artificial barriers” to care and move faster and engage members, while providing support and resources to ensure a healthier pregnancy.

“Once health plans have identified pregnant members, it is critical that they maintain consistent engagement to avoid missed interventions and opportunities,” Torroella explained.

“As more than 60 per cent of pregnancy-related deaths are preventable, it is important that new mums are aware of all recommended prenatal and postpartum care options available to them.

“This is a huge first step in reducing maternal mortality and morbidity.”

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Study reveals effects of obesity and metabolic syndrome on breast cancer

Women who eat a low-fat diet can decrease their risk of dying from breast cancer by 21 per cent, new findings suggest

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A new US study has revealed the effects obesity and metabolic syndrome can have on breast cancer.

Both obesity and metabolic syndrome, a cluster of conditions like high blood pressure and high blood sugar, increase the risk of breast cancer, but in differing ways for different subtypes of the cancer.

A University of Oklahoma researcher helped to lead a study that produced those results, which may help physicians better care for patients at higher risk for breast cancer.

The study is from the Women’s Health Initiative (WHI), an effort that began in the early 1990s and continues to yield valuable data about postmenopausal women’s risks for cancer, cardiovascular disease, osteoporosis and other conditions.

The initiative, funded by the National Heart, Blood and Lung Institute, a component of the National Institutes of Health, is the largest women’s health prevention study ever conducted.

Robert Wild, a professor of obstetrics and gynecology in the OU College of Medicine, has been involved with the WHI since its beginning and is a co-author of the latest study, published in Cancer.

The research followed another WHI study showing that women who ate a low-fat diet for about eight years decreased their risk of dying from breast cancer by 21 per cent over the next 20 years.

Those findings led researchers to consider whether the reduced risk was related to a decrease in obesity or an improvement in the conditions associated with metabolic syndrome. As it turns out, the answer is both.

“This study shows that obesity had an effect on breast cancer independent of metabolic syndrome, and that metabolic syndrome had an effect on breast cancer independent of obesity,” Wild said. “And they affected various subtypes in different ways, which influenced whether women were diagnosed with breast cancer and whether they died from it.”

The upshot of the study is simpler: keeping both waist circumference and metabolic conditions under control is important to reduce the risk of being diagnosed with breast cancer and the risk of dying from it.

“This study is essentially saying to get back to the basics,” Wild said. “Prevention is important, and we need to be paying attention to both metabolic syndrome and weight.”

Metabolic syndrome includes increased blood pressure, high blood sugar, excess body fat around the waist and abnormal cholesterol or triglycerides, all of which also increase the risk for cardiovascular disease and diabetes.

The study found that:

  1. Metabolic syndrome is significantly associated with 53 per cent more deaths after breast cancer and a 44 per cent higher breast cancer mortality.
  2. Metabolic syndrome is also associated with poor prognosis in two specific types of breast cancer: oestrogen receptor (ER)-positive and progesterone receptor (PR)-negative.
  • ER-positive breast cancer occurs when high levels of oestrogen in the breast cancer cells help the cancer grow and spread. This type of cancer represents 70-80 per cent of all breast cancer diagnoses and typically responds well to hormone therapy, which blocks hormones like oestrogen.
  • PR-negative breast cancer means the cancer has no hormone receptors and therefore does not respond to hormone therapy. It also tends to grow faster than hormone-positive cancers.
  1. Obesity status is significantly associated with more total breast cancers and more deaths after breast cancer, with higher mortality only in women with severe obesity.
  2. Obesity status is also associated with good prognosis in ER-positive and PR-positive cancers. Both can be treated with hormone therapy and tend to grow more slowly than those that are hormone receptor-negative.

Wild said: “The Women’s Health Initiative is the gift that keeps on giving. It is a great opportunity to make use of quality information. In the beginning, I don’t think we knew what a valuable resource it would still be years later.”

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