health and wellness
FDA Provides Update on Agency Response to Monkeypox Outbreak
Last Updated on June 30, 2024 by Daily News Staff
Today, the U.S. Food and Drug Administration is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics. The agency has also established a dedicated website to provide important information about the FDA’s ongoing regulatory activities related to monkeypox along with frequently asked questions. The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical countermeasures.
“The FDA has been closely tracking reports of monkeypox transmissions in the United States with our federal public health partners and coordinating preparedness efforts accordingly,” said FDA Commissioner Robert M. Califf, M.D. “We understand that while we are still living with COVID-19, an emerging disease may leave people feeling concerned and uncertain, but it’s important to note that we already have medical products in place, specifically an FDA-approved vaccine for the prevention of monkeypox disease and an FDA-cleared diagnostic test. The FDA is using the full breadth of its authorities to make additional diagnostics and treatments available. We will continue to collaborate with our partners across all sectors to expand accessibility to countermeasures and bolster the tools in our arsenal as appropriate.”
The monkeypox virus is part of the same family of viruses as variola virus, the virus that causes smallpox (a virus that has been eradicated globally). Both monkeypox and smallpox fall into the category of “orthopoxviruses.” Monkeypox is generally not fatal and typically resolves on its own without treatment. The current outbreak in the U.S. usually presents as a rash on the body, face or genital area. Although there is a very low risk of dying, there have been reported complications including severe pain, at times requiring hospital admission.
Diagnostics
Since the first case of monkeypox in the U.S. was detected, the FDA has been working with commercial laboratories and manufacturers to make monkeypox tests more readily available to consumers who need them. The Centers for Disease Control and Prevention (CDC) has an FDA-cleared non-variola orthopoxvirus test that can detect monkeypox by a swab from a monkeypox lesion (rash or growth). At this time, this is the only FDA-cleared test. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing. In July 2022, the FDA issued a safety communication advising people to use swab samples taken directly from a lesion when testing for the monkeypox virus.
The FDA-cleared monkeypox test is being offered by the CDC and throughout many laboratories that include the CDC’s public health Laboratory Response Network. In addition, federal public health authorities have worked with industry to make the test available through five large commercial laboratories. The agency is working closely with the CDC to increase production of its FDA-cleared test and the FDA has cleared the use of additional reagents and instruments to increase the throughput of the CDC test.
The FDA will continue to work with the diagnostic community to augment access to accurate testing to support the response.
Vaccines
In 2019, the FDA approved the JYNNEOS Vaccine for the prevention of smallpox and monkeypox in adults 18 years of age and older determined to be at high risk of infection. JYNNEOS is the only vaccine approved for the prevention of monkeypox in the United States. Although clinical trials and data are limited because of the small number of cases until now, the immunological response to vaccine administration is consistent with effective prevention of the disease.
Following the emerging public health crisis closely, the FDA was aware that there were close to 800,000 doses of this vaccine pending release this fall following approval of additional manufacturing capabilities at one of the plants where the vaccine is made. With this in mind, the agency worked with HHS partners and expedited the submission of the required application for the company’s manufacturing changes in order to make these doses available to those in need. After accelerating the timeline for an inspection of the plant from fall to earlier this month, the FDA has finished its evaluation of the required information to validate product quality and has determined that the vaccine meets its quality standards.
On July 26, the agency approved a supplement to the biologics license for the JYNNEOS Vaccine, to allow for additional manufacturing capabilities at the facility. Given the emerging public health need, the FDA previously facilitated the shipment of manufactured doses to the U.S. so that they would be ready to be distributed once the manufacturing changes were approved. With the supplement approval, those manufactured doses may now be further distributed and administered. Additional doses manufactured at this plant can help address the need for this vaccine moving forward.
Therapeutics
There is no FDA-approved or authorized medicine for the treatment of monkeypox disease; however, TPOXX (tecovirimat), an antiviral medication, is being made available through the CDC under an FDA authority called Expanded Access or “compassionate use.” The FDA continues to work with the CDC to streamline their Expanded Access Program for monkeypox to facilitate access.
There are currently no human data demonstrating the efficacy of TPOXX for the treatment of monkeypox, or the safety and pharmacokinetic profile (which helps us understand what the human body does to a drug). Although expanded access program is available, conducting randomized, controlled trials to assess TPOXX’s safety and efficacy in humans with monkeypox infections is essential.
The FDA has more information on TPOXX’s approval for smallpox under the “Animal Rule” regulations on its monkeypox webpage.
Source: FDA
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Study Links Agent Orange Exposure to Higher Risk of Rare Melanoma
A study revealed that U.S. veterans exposed to Agent Orange are at increased risk of developing acral melanoma, a rare skin cancer located in areas not typically exposed to sunlight. With higher odds of diagnosis and poorer prognosis, early detection in veterans is vital for effective treatment and improved outcomes.
(Feature Impact) A new study found U.S. veterans exposed to Agent Orange face a higher risk of developing a rare and often overlooked form of melanoma that appears on the hands and feet, and under the nails.
Researchers reported in “JAMA Dermatology” that veterans with documented exposure to the herbicide had significantly higher odds of developing acral melanoma, a subtype of skin cancer that forms on the palms, soles and nail beds.
Unlike most melanomas, which are associated with ultraviolet radiation, acral melanoma develops in areas not typically exposed to the sun. It can resemble a bruise under a toenail or a dark patch on the bottom of a foot – locations that are easily missed and not commonly associated with skin cancer.
Because of its unusual appearance and location, acral melanoma is often diagnosed at later stages, when treatment is more difficult and survival rates are lower.
The researchers analyzed 20 years of Veterans Health Administration data, comparing more than 1,200 veterans diagnosed with acral melanoma with more than 5,000 veterans without melanoma. Veterans exposed to Agent Orange had about 30% higher odds of developing the disease.
The findings suggest Agent Orange may be an underrecognized risk factor for acral melanoma, particularly for veterans who may not view themselves as at risk for skin cancer because of limited sun exposure or darker skin tones.
“Identifying exposures that may increase risk can help inform earlier recognition and, ultimately, earlier diagnosis when treatment is most effective,” said Marc Hurlbert, chief executive officer of the Melanoma Research Alliance and a principal investigator on the study.
Senior author Dr. Rebecca I. Hartman of Brigham and Women’s Hospital said acral melanoma behaves differently from other melanomas and often responds less well to current therapies.
“Acral melanoma has a poorer prognosis than the more common cutaneous melanoma because it is often diagnosed at later stages,” Hartman said. “Identifying risk factors is critical to improving detection and outcomes.”
Agent Orange was used extensively during the Vietnam War and exposure has been linked to several cancers and chronic illnesses. These findings add to evidence the herbicide may also affect the skin in ways not reflected in traditional melanoma awareness efforts.
Acral melanoma has also been associated with sex, race and ethnicity, and prior skin lesions. Researchers said the study supports treating the disease as distinct from sun-driven melanomas that dominate public education campaigns.
For veterans, the research highlights the importance of examining less visible areas of the body, including the bottoms of the feet, between the toes and under the nails. Changes in nail color, dark streaks or unexplained spots on the palms or soles should be evaluated by a health care provider, especially for those with known Agent Orange exposure.
Researchers said the findings could help guide future screening strategies for higher-risk populations and encourage further study of why acral melanoma differs biologically from other skin cancers.
Find more information at curemelanoma.org.
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Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
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Progress, Not Perfection: How Healthy Habits Can Stack Up One Step at a Time
The article emphasizes that achieving better health relies on progress, not perfection. It advocates for realistic goals and highlights tools like My Life Check for personalized health assessments. Small, manageable changes in diet, exercise, sleep, and stress management can significantly impact overall well-being, making healthy habits more attainable and sustainable.
Progress, Not Perfection: How Healthy Habits Can Stack Up One Step at a Time
(Feature Impact) Despite the best of intentions, it’s common for plans to build healthier habits to fall flat. Often, the culprit isn’t a lack of motivation or discipline; rather, it’s unrealistic expectations.
Overhauling your lifestyle requires a level of commitment that isn’t always practical. Understanding your personal health needs and the challenges you need to overcome can help give you a more realistic roadmap toward better health.
Tools to Guide You
Every plan needs a starting point and there are many reputable sources that can help guide you toward a plan that addresses your personal health needs.
For example, the American Heart Association introduced My Life Check, a simple, free tool to help individuals understand their heart health and what’s driving it. Users answer simple questions about their daily habits and health factors to get a personalized Heart Health Score in minutes.
The results are private and downloadable, giving you full control of your information. The tool turns big goals into small, specific actions you can start right away. Knowing your numbers relative to your heart health (and where you are in comparison to target ranges for optimal health) can help you decide how to build a better map to get you where you want to be.
While the report is customized to each individual, no personal data is stored and answers are only used to calculate health scores and provide personalized recommendations and practical steps to improve your health, so you can use your results to focus on what matters most to you. Every small step you take, such as moving more, eating smarter, sleeping better or managing stress, can add up over time.
Finding Your Path
Once you’re armed with data and know where you stand on your heart health numbers, small steps become clearer and more manageable. That knowledge makes it easier to choose one area to focus on, such as getting more sleep, taking daily walks or adding more color to your meals.
Healthy changes don’t need to be expensive or complicated. The best habits are ones that fit real life when every action you take moves you closer to your goals.
Staying motivated and on track is also easier when you can check back in, see your progress and realize the steps you’re taking are making an impact. Checking in every few months to see how you can grow gives you the chance to celebrate your progress, learn from challenges and keep building lasting habits that feel good.
To get started with personalized tips to set your own health goals, visit heart.org/mylifecheck.
Healthy Habits for Everyday Life
Eat Smart
Choose foods that help you feel your best, one meal at a time. Add more color to your plate and focus on balance, not restriction. Simple, affordable swaps can make a real difference.
Smart Tip: Aim for an overall healthy eating pattern that includes whole foods, fruits and vegetables, lean protein, nuts, seeds and cooking in non-tropical oils such as olive and canola.
Move More
Find movement that fits your life, such as a walk, a stretch or dancing while you cook. Every bit of activity counts and it all supports your heart and mind. Move for joy, not just for results.
Smart Tip:Adults should get 150 minutes of moderate physical activity (or 75 minutes of vigorous activity) per week. Kids should aim for 60 minutes every day, including play and structured activities.
Sleep Well
Rest is a foundation of good health, not a reward. Protect your bedtime routine and give your body the recovery it deserves. Notice how good sleep makes everything else easier.
Smart Tip: Most adults need 7-9 hours of sleep each night. Children require more. Adequate sleep promotes healing, improves brain function and reduces the risk for chronic diseases.
Manage Stress
Check in with yourself regularly, both mentally and emotionally. Create simple moments to pause, breathe, laugh or step outside. Connection, kindness and calm all support a healthy heart.
Smart Tip:The first step to stress management is awareness. Step “away from yourself” for a moment. Objectively ask yourself, “Is my stress level too high?” If so, look at what might be causing that stress.
Ideas for Incremental Changes
- Dedicate 15 minutes at the beginning or end of the day to focus on self-care, whether it’s unwinding with some music, writing down your goals or reflecting on the highlights of the day.
- Aim to add an extra serving of fruits or veggies each day, such as creating a savory veggie omelet or exploring new smoothie blends that let you pack in the produce on the go.
- Give your cabinets a quick update and put the smaller plates front and center. When you use a smaller plate, you can fill it while still sticking to recommended serving sizes.
- If you’re not a fan of the gym, think about how your hobbies can play a role in your physical activity. Even gardening counts as physical activity, so get creative to get moving with an activity you truly enjoy.
- Establish a bedtime routine that allows you to ease into sleep more easily. Once you feel the impact of better-quality rest, you may find yourself more motivated to make a regular bedtime a priority.
Photos courtesy of Shutterstock
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4 Tips to Maximize Nutritional Goals While On a GLP-1
GLP-1 medications for weight loss have gained popularity, with new research emphasizing the importance of nutrition and lifestyle. Prioritizing protein and fiber can combat common side effects like nausea and constipation, while staying hydrated and eating smaller meals enhances tolerance. Adopting these habits may improve weight loss results for GLP-1 users.
(Feature Impact) The first GLP-1 (Glucagon-Like Peptide-1) medication was approved for weight loss use more than a decade ago with new more effective versions being approved by the FDA over the past few years. As the use of these medications continues to rise, new research highlights the important role nutrition and lifestyle habits can play in supporting muscle, metabolism and long-term weight loss when using the medication.
Whether you’re new to GLP‑1s or navigating the next phase of your journey, small nutrition shifts powered by protein, fiber and hydration can help you feel strong, confident and supported.
Common side effects experienced by GLP-1 users are often digestive and include nausea, constipation, stomach pain, bloating and more. A pilot clinical trial by Atkins suggests pairing GLP‑1 use with targeted macronutrients, especially protein and fiber, may support healthier body composition and a lower-carb diet with higher protein and fiber intake is well tolerated.
Feast On Fiber
Digestive slow‑downs, including constipation, are among the most common GLP‑1 side effects. Prioritizing fiber not only helps food move comfortably through the body, it supports your gut health and steady energy. Many fibers are prebiotics, meaning they promote the growth of beneficial gut bacteria. Prioritize foods like apples, melon, berries, cruciferous vegetables and leafy greens to boost fiber intake.
Prioritize Protein
When your appetite changes, structure helps. Anchoring your day with reliable protein sources helps make nutrition easy. Prioritizing protein may help prevent lean muscle loss, and nutrient dense protein sources can help you get enough essential nutrients to support overall health. Supporting a protein- and fiber-rich diet can start with a solution like Atkins High Protein Shakes, which are packed with 30 grams of protein and 7 grams of prebiotic fiber and provide more than 20 essential vitamins and minerals.
Designed to be an ally for your nutritional goals, they’re gluten-free, low-glycemic and keto-friendly with 3 grams of net carbs and 1 gram of sugar per serving. Experts recommend making sure you’re consuming enough protein to help limit lean muscle loss when using a GLP-1 to lose weight.
Hydrate to Help Prevent Side Effects
GLP-1 users in particular are encouraged to prioritize fluids. Staying hydrated can help with both constipation and nausea, two common side effects. Drinking water helps support kidney and liver function, which are vital for weight loss and overall health. Adequate fluids help food move through your body, combat fatigue and replenish losses from potential nausea or constipation, preventing complications and improving tolerance to GLP-1s.
Eat Small, Frequent Meals
Large meals can feel uncomfortable when digestion slows. Instead, focus on smaller, more frequent eating moments that give your body a steady supply of nutrients without overwhelming your system.
For an easy, GLP‑1‑friendly option, try Atkins High Protein Bars, which are high in protein and fiber while minimizing net carbs. Available in flavors like Cookie Fusion, Chocolate Peanut Butter and Brownie Delight, they’re a satisfying way to stay fueled between meals and a simple solution when appetite cues are muted. The snacks are designed to take the guesswork out of choosing high‑protein, low‑carb options that support your goals.
Living well on a GLP‑1 is about support, confidence and clarity. Consuming adequate amounts of protein and fiber, staying hydrated and maintaining daily structure can help you feel energized and empowered every step of the way. By following nutritional guidelines and making mindful lifestyle choices, GLP-1 users can experience better outcomes on their weight loss journeys.
To explore products that prioritize protein and fiber that can be a part of anyone’s daily diet, visit Atkins.com.
Photo courtesy of Shutterstock
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Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
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