health and wellness
FDA Provides Update on Agency Response to Monkeypox Outbreak
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
5 strategies to combat stressful triggers
(Family Features) Stress, the physical or mental response to external causes like overwhelming work assignments or difficult life moments, can add unnecessary pressure to your day to day. While everyone feels stress from time to time, when left untreated or unrecognized, it can begin to wreak havoc in the form of anxiety.
In honor of National Stress Awareness Month, consider these strategies to combat stress from the National Institutes of Mental Health.
Learn Your Triggers
Different events and situations cause stress for different people. Knowing what triggers your stress to kick in – mounds of office paperwork, important financial decisions or hectic mornings, for example – can help you plan and prepare for stress-inducing moments.
Exercise and Eat Right
Maintaining physical health can be beneficial for mental health, too. Find time to do exercises you enjoy like walking, jogging, yoga or playing a sport. Identifying activities that bring you joy can make it easier to fit 30-60-minute workouts into your schedule without adding even more stress. Complement your workout routine with nutritional meals that help you stay on track with your fitness goals.
Practice Relaxation
Whether you find inner peace through journaling, breathing exercises, reading or some other form of slowing down, find what works for you and prioritize fitting it into your daily schedule. Relaxing activities help you slow down the pace of life, providing a chance to reset by doing something you enjoy.
Get Enough Sleep
A lack of quality sleep can add to stress. Creating a bedtime routine can increase your sleep habits and help you achieve the expert-recommended 7-9 hours per night. Put away electronics, which can interfere with your ability to calm your mind, and find an activity that puts you at ease like reading a book or listening to relaxing music. Ensure your bedroom is optimized for comfort by making it cool, dark and quiet.
Create a Network of Support
Everyone experiences stress. Reach out to family members and close friends you can lean on in stressful and frustrating moments. Share your feelings and encourage others to do the same, which can increase trust and help everyone in your circle cope in a positive way.
Find more ways to combat stress and care for your mental health at eLivingtoday.com.
Photo courtesy of Unsplash
SOURCE:
eLivingtoday.com
(Family Features) For those with asthma, understanding what can trigger symptoms is a part of getting the condition under control. Some of the same things that cause allergies can worsen symptoms, but not every allergen is a trigger for everyone with asthma. The places where you live, learn, work and play can expose you to common asthma triggers like pet dander, dust mites, pests like rodents and cockroaches, mold, cigarette smoke, pollen, air pollution and more. Managing triggers is just one part of controlling asthma, however. Work with your health care provider to make an asthma action plan and keep track of your symptoms and where you are when they occur. Learn more at nhlbi.nih.gov/BreatheBetter.
Food and Beverage
The 10 Best Healthiest Seafood Options: Nutrient-Rich and Sustainable Choices
“From sardines to salmon, discover the top 10 healthiest and sustainable seafood options for a nutrient-rich diet. 🐟🌱 #Seafood”
Seafood is a treasure trove of essential nutrients and beneficial compounds that can significantly contribute to a healthy diet. From the omega-3 fatty acids that promote heart health to the abundance of vitamins and minerals, incorporating seafood into your meals can have a positive impact on your overall well-being. In this blog post, we will delve into the ten best healthiest seafood options, considering their nutritional content, sustainability, and potential contaminants.
- Sardines:
These small fish are incredibly nutritious, packed with omega-3 fatty acids, vitamin B12, vitamin D, and calcium. Sardines are also low in contaminants and are considered one of the most sustainable seafood options available. - Salmon:
Salmon is well-known for its impressive omega-3 content. It also provides high-quality protein, vitamin D, vitamin B12, and selenium. Opt for wild-caught Alaskan salmon for the best nutritional benefits and sustainability. - Oysters:
Oysters are a true nutritional powerhouse, rich in vitamins B12, D, and zinc. They are a sustainable choice and an excellent source of lean protein. Including oysters in your diet not only benefits your health but also supports local marine ecosystems due to their ability to filter water. - Mackerel:
Mackerel is another fish that boasts high levels of omega-3 fatty acids, along with vitamin D, vitamin B12, and selenium. This flavorful fish is considered a sustainable choice and offers numerous health benefits. - Rainbow Trout:
Rainbow trout is a deliciously mild-flavored fish that is packed with omega-3 fatty acids, protein, vitamin B12, and iron. It is a sustainable choice, particularly when sourced from responsible fish farms. - Clams:
Clams are an excellent source of protein, vitamin B12, iron, and selenium. They are sustainable, low in contaminants, and make a versatile addition to dishes like pasta, chowders, and stir-fries. - Herring:
Herring is an oily fish that delivers a healthy dose of omega-3 fatty acids, vitamin D, and vitamin B12. It is an eco-friendly choice and can be enjoyed smoked, pickled, or grilled. - Cod:
Cod is a lean white fish that provides protein, vitamin B12, selenium, and phosphorus. It is known for its mild flavor and versatility in cooking methods. - Shrimp:
Shrimp is low in calories and rich in protein, vitamin D, and selenium. Choose sustainably sourced shrimp to minimize environmental impact and ensure a healthier choice. - Anchovies:
Anchovies may be small in size, but they are big in nutritional value. These tiny fish deliver omega-3 fatty acids, calcium, and vitamins D and E. They are also a sustainable choice when sourced responsibly.
When it comes to the healthiest seafood options, there is an abundance of choices that offer an array of essential nutrients while also being environmentally responsible. Sardines, salmon, oysters, mackerel, rainbow trout, clams, herring, cod, shrimp, and anchovies are all fantastic choices to boost your overall health while supporting sustainable fishing practices. Incorporate these nutrient powerhouses into your diet and savor the benefits they provide for your well-being and the planet.
What are the Risks of Eating Seafood?
Although seafood is a nutritious option to fulfill dietary nutrient gaps, there are some environmental and health concerns related to its consumption.
Seafood may contain toxins, viruses, parasites, and bacteria that can be harmful if consumed. To avoid getting sick, it is essential to cook fish and shellfish thoroughly. As per the USDA guidelines, most seafood should be cooked to an internal temperature of 145 degrees Fahrenheit.
Contaminants, including Mercury and Others
Overconsumption of certain seafood varieties can have negative health effects due to the presence of contaminants. For instance, specific fish species contain high levels of mercury, a heavy metal that can be easily absorbed by the body. Mercury accumulation is more common in larger fish, as they consume smaller fish that have ingested mercury-rich plankton. Consequently, larger and older fish are typically the most mercury-contaminated.
Regularly consuming foods high in mercury can result in mercury accumulation in the body, leading to health problems like high blood pressure, heart attack, and developmental delay in offspring. Mercury is toxic and can have detrimental effects on the body.
Mercury can have a greater impact on certain groups, such as pregnant and breastfeeding women, as well as children, who are more susceptible to its effects.
To reduce the amount of mercury in your diet, avoid consuming seafood like shark, certain types of tuna, swordfish, tilefish, and king mackerel as they have high mercury levels. Instead, opt for low-mercury options such as trout, cod, oysters, clams, herring, salmon, and sardines.
Recommendations for Incorporating Seafood into Your Eating Plan
Eating seafood can boost the quality of your diet and support and protect your health. However, it’s important to consider the nutrition and environmental impact of seafood when narrowing down options to add to your diet.
Adding seafood to your diet can boost its nutritional quality and promote your overall health. However, it is essential to consider the nutritional composition and environmental impact of various seafood options before including them in your meals.
Read the article in Health titled Healthiest Seafood Options, Ranked for further insight into the topic. https://www.health.com/healthiest-seafood-8630471
https://stmdailynews.com/category/food-and-beverage/
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