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
https://stmdailynews.com/category/lifestyle/health-and-wellness
Lifestyle
Strong at Every Age: How Women Can Help Combat Muscle Loss
Combat Muscle Loss: Aging is inevitable, but losing muscle and mobility doesn’t have to be. Consider these tips to help women protect their muscle health.
Strong at Every Age: How Women Can Help Combat Muscle Loss
(Feature Impact) Aging is inevitable, but losing muscle and mobility doesn’t have to be. For many women, maintaining strength, independence, energy and mobility are top priorities as they get older, particularly as they deal with the mental and physical responsibilities that come with working, caregiving, keeping up with friends, hobbies and enjoying an active lifestyle.
In fact, 58% of women in the United States are actively focused on staying healthy as they age, according to a recent survey commissioned by Viactiv, a line of award-winning supplements for women known for their unique formats and flavors. However, 73% of respondents weren’t aware of sarcopenia, or age-related muscle loss. According to the “International Journal of Women’s Health,” age-related muscle loss often begins between ages 30-35, with women losing 3-8% of their muscle mass per decade and increasing to 5-10% loss per decade after age 60.
Hormonal changes, decreased activity levels, stress, poor sleep and inadequate nutrition can all contribute to the decline in muscle, which can also negatively impact balance, bone health, metabolism, posture and everyday mobility.
Yet, despite 70% of women reporting some level of concern about muscle loss, 54% are unsure how to protect their muscle health.
“Women want to stay strong, active and independent as they age, but many are getting mixed messages about what actually supports long-term muscle health,” said Dr. Tania Elliott, a dual board-certified physician in internal medicine. “A lot of women are already making healthy choices like walking and staying active, which is a great start. However, maintaining muscle health really requires a more complete approach, and one that starts earlier than most women think, which is in your 30s.”
Prioritize Strength Training
Many women report barriers such as lack of time (15%), feeling overwhelmed (23%) or simply not enjoying exercise (23%). The key is finding realistic, sustainable habits. While walking and cardio exercise aid in heart health, which 58% of survey respondents report already engaging in, strength training is one of the most effective ways to preserve and build muscle as you age. Still, just 34% of women report doing strength or resistance training.
You don’t need an intense fitness regimen to support healthy aging. Aiming for at least two strength-focused workouts a week – lifting weights, using resistance bands, practicing weight-bearing yoga or doing bodyweight exercises like squats and pushups – that target major muscle groups can help maintain muscle health. The goal is to fatigue your muscles during sets so they build.
Fuel Muscles with Proper Nutrition
Exercise is only part of the equation. Muscles also need proper nutrition to recover and stay strong. Protein plays a critical role in maintaining muscle mass, especially as women age. Incorporating high-quality protein throughout the day, such as eggs, Greek yogurt, fish, lean meats, beans, lentils, nuts and seeds, may help support muscle repair and overall strength.
Support Healthy Aging with Supplements
In addition to a balanced diet and exercise, some women may consider supplements that support healthy aging and energy production, including CoQ10, which is a naturally occurring antioxidant that helps cells produce energy. According to research published in “The Journal of Nutrition, Health and Aging,” because muscles require significant energy to function, CoQ10 shows potential for managing sarcopenia by improving mitochondrial function and reducing oxidative stress.
An option like Viactiv CoQ10 Cardio Complete, available in a tasty fruit-flavored chew, can help support heart health, muscles, nerve function and daily energy. Enhanced with vitamins D3 and K2, it provides daily essential nutrition for women without the need to swallow a large pill.
Practice Healthy Habits
Muscle health is influenced by more than workouts. Sleep, stress management and daily movement all play important roles. Adopting some simple habits, including prioritizing quality sleep, stretching regularly, staying properly hydrated, reducing sedentary time throughout the day and practicing stress-management techniques, like yoga, meditation or deep breathing, can help aid in healthy aging, including maintaining muscle.
The earlier women begin prioritizing muscle health, the better positioned they may be to maintain strength and mobility as they age. Visit Viactiv.com for more information and resources to help combat muscle loss.
Photo courtesy of Shutterstock
SOURCE:
Viactiv
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(Family Features) Food insecurity isn’t a new problem in the United States, but the economic upheaval created by the COVID-19 pandemic accelerated the problem.
During the pandemic, households in the United States with children experienced an increase in food insecurity, despite overall rates of food insecurity staying the same. In 2019, 13.6% of households with children were food insecure, but by 2020, that number increased to 14.8%, according to data from the U.S. Department of Agriculture.
In general, child food insecurity rates are higher than overall food insecurity rates, according to the annual Map the Meal Gap study conducted by Feeding America, a nationwide nonprofit network of food banks. According to data from the Children’s Defense Fund, this is particularly prevalent among low-income families, single mother households and Black and Hispanic households.
What Food Insecurity Means for Children
Food insecurity and hunger are closely related but not quite the same. People who are food insecure don’t have reliable, ongoing access to an adequate supply of affordable, nutritious food. Hunger is a physical condition; food insecurity reflects barriers to obtaining food such as finances, physical location and transportation.
Infants and toddlers are particularly vulnerable to nutrient deficiencies because their nutrient needs are high, especially in relation to the size of their stomachs and appetites. Caregivers in food-insecure households may have little choice but to settle for cheaper, energy-dense but nutrient-poor foods. As a result, food-insecure infants and toddlers are not receiving adequate nutrition even when they may be receiving enough calories to satisfy hunger.
Even if a child isn’t physically starving, inadequate nutrition can negatively affect health in numerous ways, including immune system function, low weight, learning and developmental delays, vitamin deficiencies and more.
Ways to Help Promote Better Nutrition
Support good nutrition during infancy and toddlerhood for your own children and others in the community with these practical tips:
- Participate in (or introduce those in need to) aid programs. Government nutrition assistance programs help provide essential nutrition needs during infant and toddler years. One example is the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), which provides a variety of resources including food and health care referrals to support mothers and young children at nutritional risk, including pregnant, breastfeeding and post-partum women, as well as infants and children up to age 5.
Another example is the Supplemental Nutrition Assistance Program (SNAP), which provides benefits low-income families can use to purchase nutritious foods. For children and adults who are enrolled in certain care programs, the Child and Adult Care Food Program (CACFP) helps ensure they have access to nutritious meals and snacks. - Make purchases that work extra hard. In addition to producing foods that encourage better nutrition for children, some brands also make contributions that help offset food insecurity. For example, for every box of Plum Organics Super Smoothies purchased, the company donates a pouch to a child in need through its “The Full Effect” program. The smoothie is a specially formulated blend of fruits, vegetables, legumes and grains with no added sugars designed to fight malnutrition and help fortify the diets of children who don’t have access to regular, healthy meals.
- Act as a role model for healthy choices. Children learn by example, so be sure your little ones see you enjoying nutritious snacks, filling your plate with appropriate portions and preparing well-rounded meals. When kids are exposed to a wide range of healthy options early in life, those food choices become the norm as they grow older.
- Volunteer at a food bank. Getting hands-on by donating your time at a local food bank can help you understand the complexity of food insecurity. Many nutritious selections are perishable, and transporting and storing perishable goods is costly. Volunteers help offset a food bank’s operational expenses by contributing labor to sort donated items, prepare deliveries and more.
To find more information about foods that provide infants and toddlers the nutrients they need, visit plumorganics.com. Photos courtesy of Getty Images
SOURCE:
Plum Organics
https://stmdailynews.com/category/food-and-drink/
Last Updated on July 17, 2026 by Daily News Staff
(Family Features) Most people think of heart attacks as debilitating pain in the chest. However, that’s not always the case, especially for women, and missing the signs can be a matter of life and death.
Although heart disease is the leading cause of death among American women, according to the American Heart Association, symptoms are often overlooked or explained away as less worrisome conditions.
“Men and women experience many aspects of life differently, and heart disease is no exception,” said LeAnne Bloedon, MS, RD, vice president of clinical development, Esperion Therapeutics. “Symptoms of a heart attack aren’t as obvious as many women think, and failing to recognize the danger and get help can have catastrophic results.”
One heart disease risk factor, for example, is high LDL cholesterol. Often referred to as a “silent killer,” it doesn’t always present noticeable symptoms. In fact, data suggests women with high LDL cholesterol are not diagnosed or treated as early or aggressively as men, which can put women at an increased risk for cardiovascular events. Understanding how men’s and women’s risk and symptoms differ may help identify and treat a serious heart health problem before it causes lasting damage.
Anatomy Differences
Some differences between men and women are present in the body’s internal systems, including the cardiovascular system. Women generally have smaller hearts and narrower blood vessels.
This can affect heart health in numerous ways, including less efficient stress responses and greater risk of widespread plaque buildup, especially in smaller vessels, called microvasculature, which can pose treatment challenges.
Cholesterol Buildup
Hormones influence aspects of the body’s function, including cholesterol levels. Estrogen, a female sex hormone, raises HDL (good) cholesterol levels. This may be why women tend to have more HDL cholesterol and lower LDL (bad) cholesterol than men, especially before they reach menopause, though inherited high cholesterol can affect women of all ages.
“It’s critical to raise awareness about the importance of measuring LDL cholesterol, diagnosing high cholesterol and treating elevated LDL cholesterol per guidelines and individual patient needs,” Bloedon said.
Risk Factors
While there are shared risk factors for heart disease among men and women (such as obesity, high blood pressure and diabetes), some risk factors disproportionately affect women. For example, uncontrolled cholesterol in women, particularly after menopause, can increase the risk of heart disease and stroke.
Care and Treatment
“While you may not be able to fully prevent heart disease, you can understand the risks and take proactive steps,” Bloedon said. “Commit to a healthy, smoke-free lifestyle. Exercise regularly and eat a well-balanced diet with limits on processed foods, sugar, sodium and alcohol. Take any medications as directed by your health care provider.”
Statins, which reduce the production of cholesterol in the liver and lower cholesterol levels in the bloodstream, are the medications most often prescribed to help manage high LDL cholesterol. While generally well-tolerated, statin intolerance (the inability to take a statin at any dose or the recommended dose) does occur in some patients and is more common in women.
Talk with your doctor about other steps you can take to manage elevated LDL cholesterol levels and learn more about women’s heart health at goredforwomen.org.
Symptoms of Heart Attacks in Women
Women’s experiences with heart disease may be quite different from men.
For example, according to the Heart Disease Foundation, women are likely to be older when they experience a heart attack. They may also attribute symptoms to other conditions, such as diabetes or arthritis.
Further complicating matters, several diseases mimic heart attacks so getting to the root of the problem can be tricky. Women are more apt than men to experience a coronary spasm, coronary dissection or broken heart syndrome.
What to Watch For:
- Like men, women experiencing a heart attack may notice prolonged or reoccurring chest pain or pressure.
- In women, that pain may extend to the arms, back, neck, jaw and stomach.
- Some women experience shortness of breath with no chest pain at all.
- Other symptoms women are more likely to report can be easily mistaken for other conditions. Some of these signs include unexplained fatigue, disruptions to normal sleep patterns, lightheadedness, nausea and cold sweats.
Photo courtesy of Shutterstock
SOURCE:
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