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FDA Approves Palforzia for Young Children with Peanut Allergy: A New Era of Allergy Management

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selective focus of shelled peanuts. Palforzia
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In a significant advancement for families grappling with peanut allergies, the U.S. Food and Drug Administration (FDA) has expanded the approval of Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp) to include children aged 1 to 3 years. This decision marks a pivotal step in the management of peanut allergies, a condition affecting millions of children and their families. Let’s delve into what this means for young patients and their caregivers.

Understanding Palforzia

Palforzia is an oral immunotherapy product designed to help individuals with a confirmed diagnosis of peanut allergy build tolerance to peanuts over time. The treatment works by gradually introducing small amounts of peanut protein, thereby reducing the risk of severe allergic reactions, including anaphylaxis, that can occur with accidental exposure.

Originally approved in January 2020 for individuals aged 4 to 17 years, the recent expansion to include toddlers offers hope to a younger demographic. This means that children as young as 1 year old can now embark on a treatment regimen aimed at mitigating the severity of allergic reactions to peanuts.

The Treatment Journey: Initiation, Up-Dosing, and Maintenance

The treatment process with Palforzia involves several stages:

  1. Initiation of Treatment: The process begins with a carefully monitored initiation phase, where the child is introduced to Palforzia under the supervision of a healthcare provider. This stage is crucial to ensure safety and to monitor for any potential reactions.
  2. Up-Dosing: After the initial phase, the dosage of Palforzia is gradually increased over several weeks. This up-dosing phase helps the child’s immune system adjust to the presence of peanut allergens, aiming to build tolerance.
  3. Maintenance: Once the appropriate dose is achieved, the child enters the maintenance phase, where they continue to take Palforzia daily. This phase is designed to sustain the tolerance that has been developed during the up-dosing period.

Ongoing Peanut Avoidance

It’s vital to note that while Palforzia helps in building tolerance, it does not eliminate the need for strict peanut avoidance in the child’s diet. Families must continue to be vigilant and ensure that their child avoids peanuts and peanut-containing products, as exposure can still lead to allergic reactions.

Safety Measures: Risk Evaluation and Mitigation Strategy (REMS)

Given the potential for anaphylaxis associated with peanut allergies, the FDA has implemented a Risk Evaluation and Mitigation Strategy (REMS) for Palforzia. This strategy includes specific safety measures to ensure that the treatment is used safely:

  • Healthcare Provider Training: Providers must be trained in the management of allergic reactions and the safe administration of Palforzia.
  • Patient Monitoring: Children receiving Palforzia must be monitored closely during the initiation and up-dosing phases to quickly address any adverse reactions.
  • Patient and Caregiver Education: Comprehensive education is provided to families about the signs of allergic reactions, emergency response protocols, and the importance of continued peanut avoidance.

Looking Ahead

The expansion of Palforzia’s approval to younger children represents a hopeful development for families affected by peanut allergies. With proper medical supervision and adherence to safety protocols, this treatment can significantly reduce the risk of severe allergic reactions, allowing children to navigate their environments with greater confidence and safety.

As research continues to evolve in the field of food allergies, the FDA’s decision underscores the ongoing commitment to providing innovative solutions for managing allergic conditions. For families, this means a brighter future, filled with more options for treatment and, ultimately, a better quality of life for their children.

If you think Palforzia might be right for your child, consult with a healthcare provider who specializes in allergy management to discuss the benefits and considerations of this groundbreaking treatment.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treatment-peanut-allergy-children?utm_medium=email&utm_source=govdelivery

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Sports

College Basketball Stars with Personalized Nutrition and Hydration at 2025 Combine in Tampa, Florida

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Global Health and Wellness Leader Brings 20 Years of Expertise in Performance Nutrition to Empower Female Athletes LOS ANGELES /PRNewswire/ — Herbalife, a premier health and wellness company, community and platform, today announced it is the Official Nutrition and Hydration Partner of the Lilly 2025 Women’s College All-Star Combine, scheduled for Friday, April 4. The inaugural event will provide basketball players with an unprecedented platform to showcase their talents and gain visibility from scouts and recruiters, opening doors to new opportunities in their careers. With over two decades of experience supporting professional athletes globally, Herbalife will bring its expertise in personalized nutrition and hydration strategies, offering athletes at the combine access to world-class resources and products.

“We are proud to bring over 20 years of experience of fueling athletes to college basketball players,” said Krissy Lines, director of sports performance, nutrition, and education at Herbalife. “Our mission is to deliver personalized nutrition and hydration strategies that empower each athlete to perform at her peak. This is a pivotal moment for these women, not just as athletes, but as leaders in sport, and we’re honored to provide the resources and expertise to help them take the court with confidence, strength, and readiness to shine.”   As the Official Nutrition and Hydration Sponsor, Herbalife will provide participants with expert-led nutrition education designed to address the unique needs of female athletes, including factors like metabolism, muscle mass, and hormonal fluctuations that impact their nutritional and hydration requirements. In addition, Herbalife’s science-backed products, including the Herbalife24 NSF Certified for Sport®* line, will be available to both participants and spectators. This product line is specifically formulated to help replenish essential nutrients lost through sweat, optimizing hydration, endurance, and recovery. “Having worked closely with Herbalife on several initiatives supporting athletes of all levels, I’ve seen first-hand how their expertise in nutrition education can make a significant difference in an athlete’s performance,” said Joe Abunassar, president of Herbalife IMPACT Basketball Center in Las Vegas and on-court instructor at the combine. “This combine is an incredible opportunity for these athletes, and with Herbalife’s support, they will be well-equipped to perform at their highest level. This is a great step for women in basketball, and I’m excited to see what these athletes can achieve.” In addition to supporting the combine as its Official Nutrition and Hydration Sponsor, Herbalife is also the Official Nutrition and Hydration Sponsor of the Lilly Women’s College All-Star Game, which will showcase 20 of the nation’s top collegiate basketball players as they compete one final time before transitioning to the next phase of their careers. “Herbalife’s expertise in nutrition and hydration will ensure that athletes are fully prepared to showcase their talents,” said Mark Starsiaksenior vice president at Intersport, the event organizers. “We are excited to provide this platform for women to take center stage in front of scouts and coaches, and we are grateful for Herbalife’s support in making this event a reality.” For over two decades, Herbalife has been dedicated to empowering female athletes around the world, currently sponsoring more than 50 women across a variety of sports. The company’s journey began with its very first sponsored athlete, a female athlete, and has continued to provide women in sports with the support they need to succeed. Herbalife provides athletes with access to nutritionists and dietitians, premium products, and other resources that are often lacking in female sports – giving them the tools they need to perform at their best. Through this continued support, Herbalife is helping to elevate women in sports and inspire the next generation of female athletes. For updates on how Herbalife is fueling athletes around the world, follow @Herbalife, @HerbalifeUSA on social media. *Certified for Sport® is a registered trademark of NSF International. About Herbalife Ltd.
Herbalife is a premier health and wellness company, community and platform that has been changing people’s lives with great nutrition products and a business opportunity for its independent distributors since 1980. The Company offers science-backed products to consumers in more than 95 markets through entrepreneurial distributors who provide one-on-one coaching and a supportive community that inspires their customers to embrace a healthier, more active lifestyle to live their best life. For more information, visit https://ir.herbalife.com. About Intersport
Intersport is an award-winning agency that fills the empty space between marketing campaigns and consumers—helping brands make more meaningful connections. Its industry-leading team offers expert insights in content marketing, experiential marketing, hospitality, partnership consulting and platform development. The Chicago-based agency also owns and operates events across the professional and collegiate sports landscape, including basketball, football, golf, pickleball and volleyball. Intersport has been headquartered in Chicago since its inception in 1985 and has an additional office in Detroit. Learn more at www.intersport.global and on social media (LinkedInInstagram and Facebook). SOURCE Herbalife

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Lifestyle

Connected Communities: Reducing the Impact of Isolation in Rural Areas

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isolation (Family Features) Throughout history, humans’ ability to rely on one another has been crucial to survival. Despite modern developments that help individuals live with minimal human engagement, the human need to connect remains. However, in many parts of America, a trend toward isolation is emerging. Over the past two decades, people are spending more time alone and less time engaging with others in person, according to data from the Office of the U.S. Surgeon General. One segment of Americans at particular risk of social isolation, loneliness and their negative impacts are select populations who live in rural areas. “There is an urgent need to take action and improve mental health in rural America,” said Jeff Winton, dairy farmer and founder and chairman of Rural Minds, a nonprofit mental health advocacy organization that partnered with Pfizer to raise awareness about the physical and mental risks of social isolation. “Challenges to mental health can be inherent in a rural lifestyle, including a belief in self-reliance as a virtue, fear of judgment and difficulty getting an appointment with a limited number of mental health professionals, among others.” Many Americans are increasingly spending more time alone according to the American Time Use Survey. They are increasingly more likely to take meetings, shop, eat and enjoy entertainment at home, making it easier for them to stay within their own four walls and avoid social interactions. Authentic human connection is a basic but often unacknowledged necessity for health, “as essential to survival as food, water and shelter,” according to the U.S. Surgeon General’s Advisory on the Health Effects of Social Connection and Community. Understanding Social Isolation According to the Centers for Disease Control and Prevention (CDC), about one-third of U.S. adults reported feeling lonely and about one-fourth said they don’t have social and emotional support (the basis of social isolation). The concepts of social isolation and loneliness can go hand-in-hand, but the two are actually quite different. Social isolation is defined by an absence of relationships or contact with others. Someone experiencing loneliness may or may not have social connections, but lacks feelings of closeness, support or belonging. Despite the distinction, both can have a negative impact on a person’s mental and even physical health. Several factors can influence a person’s risk for social isolation and loneliness. “Social connection is a dynamic that changes over time,” said Nikki Shaffer, senior director, occupational health and wellness, Pfizer. “Transient feelings of loneliness or solitude may be beneficial because they can serve as motivation to reconnect. However, chronic loneliness (even if someone is not isolated) and isolation (even if someone is not lonely) can represent significant health concerns.” 17384 detail image embed1 Isolation in Rural America Compared to people who live in urban areas, many rural Americans experience higher rates of depression and suicide but are less likely to access mental health care services, according to the “Health Disparities in Rural America: Current Challenges and Future Solutions” study published in “Clinical Advisor.” What’s more, CDC data shows suicide rates among people living in rural areas can be 64-68% higher than those in large urban areas. Rural areas have 20% fewer primary care providers compared to urban areas, according to a report in JAMA, and the Health Resources and Services Administration reports more than 25 million rural Americans, more than half of rural residents, live in mental health professional shortage areas. Among rural counties, 65% lack a psychiatrist. Nearly 30% of rural Americans don’t have internet access in their homes, which complicates the option for telehealth. These figures from Rural Minds exemplify the challenges facing rural America. “Some people in rural communities still don’t understand or accept that mental illness is a disease,” said Winton, who grew up on a rural farm. “Rather, a mental illness can often be viewed as a personal weakness or character flaw. A lot of the stigma around mental illness results in unwarranted shame, which adds to the burden for someone already suffering from mental illness.” Health Impacts of Social Isolation Loneliness is far more than just a bad feeling; it harms both individual and societal health. In fact, loneliness and social isolation can increase the risk for premature death by 26% and 29%, respectively. Lacking social connection can increase the risk for premature death as much as smoking up to 15 cigarettes a day or drinking six alcoholic drinks daily. In addition, poor or insufficient social connection is associated with increased risk of disease, including a 29% increased risk of heart disease and a 32% increased risk of stroke. Social isolation is also associated with increased risk for anxiety, depression and dementia. Additionally, a lack of social connection may increase susceptibility to viruses and respiratory illness. Learn more about the impact of social isolation, especially on residents of rural areas, and the steps you can take to reduce isolation and loneliness by visiting ruralminds.org.

Boost Your Social Connections

Take a proactive approach to combatting social isolation and loneliness with these everyday actions that can promote stronger social ties.
  • Invest time in nurturing your relationships through consistent, frequent and high-quality engagement with others. Take time each day to reach out to a friend or family member.
  • Minimize distractions during conversation to increase the quality of the time you spend with others. For instance, don’t check your phone during meals with friends, important conversations and family time.
  • Seek out opportunities to serve and support others, either by helping your family, co-workers, friends or people in your community or by participating in community service.
  • Be responsive, supportive and practice gratitude. As you practice these behaviors, others are more likely to reciprocate, strengthening social bonds, improving relationship satisfaction and building social capital.
  • Participate in social and community groups such as religious, hobby, fitness, professional and community service organizations to help foster a sense of belonging, meaning and purpose.
  • Seek help during times of struggle with loneliness or isolation by reaching out to a family member, friend, counselor, health care provider or the 988 crisis line.
  Photos courtesy of Shutterstock   collect?v=1&tid=UA 482330 7&cid=1955551e 1975 5e52 0cdb 8516071094cd&sc=start&t=pageview&dl=http%3A%2F%2Ftrack.familyfeatures SOURCE: Rural Minds and Pfizer

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Lifestyle

Living with a Bleeding Disorder

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(Family Features) Many people don’t think much about whether their blood is clotting properly. However, when you have a bleeding disorder, a condition that affects the way your body controls clots, it’s no small matter.

According to the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, abnormal clotting can lead to a host of problems, including excessive bleeding after an injury or during surgery.

About 3 million people in the U.S. have bleeding disorders. Some types, such as hemophilia, are inherited, meaning a person who has it is born with it. Inherited bleeding disorders are caused by certain genes passed down from parents to children. These genes contain instructions for how to make proteins in the blood called clotting factors, which help blood clot. If there is a problem with one of these genes, such as a mutation – a change in the gene’s instructions – the body may make a clotting factor incorrectly or not make it at all.

You can also have what’s called an acquired bleeding disorder, meaning you develop it during your lifetime. Acquired bleeding disorders can be caused by medical conditions, medicines or something unknown. Your risk of developing a bleeding disorder depends on your age, family history, genes, sex, or other medical conditions. If bleeding disorders run in your family, you may have a higher risk of developing or inheriting one.

Symptoms of a bleeding disorder may appear soon after birth or develop later in life and can include:

  • Excessive bleeding or bruising, such as frequent or long nose bleeds (longer than 15 minutes) or frequent or long menstrual periods
  • Petechiae, which are tiny purple, red, or brown spots caused by bleeding under the skin
  • Redness, swelling, stiffness, or pain from bleeding into muscles or joints
  • Blood in urine or stool
  • Excessive umbilical stump bleeding
  • Excessive bleeding during surgery or after trauma

If you believe you, or someone you care for, may have a bleeding disorder, talk to a health care provider. Your provider may make a diagnosis based on symptoms, risk factors, family history, a physical exam, and diagnostic tests. Health care providers typically screen for bleeding disorders only if you have known risk factors or before certain surgeries.

How your bleeding disorder is treated depends on its type. If your disorder causes few or no symptoms, you may not need treatment. If you have symptoms, you may need daily treatment to prevent bleeding episodes, or you may need it only on certain occasions, such as when you have an accident or before a planned surgery.

If you have been diagnosed with a bleeding disorder, it’s important to be proactive about your health and follow your treatment plan. To lower your risk of complications:

  • Receive follow-up care
  • Monitor your condition
  • Adopt healthy lifestyle changes

To learn more about bleeding disorders, visit nhlbi.nih.gov/health/bleeding-disorders.

A Story of Bravery, Balance, and a Bleeding Disorder

There are lots of things that make Mikey White Jr. special. He’s a dedicated athlete. He’s determined, disciplined, and optimistic. He’s also living with hemophilia, a type of bleeding disorder.

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White was diagnosed with hemophilia at age 3 after experiencing several severe bleeding episodes. He had to give up baseball and basketball, his passions, because of the high risk of injuries, but he found competitive swimming – and he’s been breaking records ever since.

“Competitive swimming is a noncontact sport, so it complements my hemophilia while still being an intense and rigorous sport,” White said.

Being an athlete with hemophilia requires support, White admits. He works with his healthcare team and coaching staff to make sure he safely manages his condition and balances it with his training. He hopes his story encourages others living with bleeding disorders to accept and appreciate their bodies the way they are.

“It doesn’t have to be a limitation,” White said.

Photo courtesy of Shutterstock

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SOURCE:
National Heart, Lung, and Blood Institute

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