health and wellness

FDA Provides Update on Agency Response to Monkeypox Outbreak

Published

2 years ago

July 29, 2022

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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Author

Rod Washington

Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.
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Health

Sleep Apnea is More Than a Snore

Published

4 days ago

July 23, 2024

Daily News Staff

(Family Features) Snoring throughout the night. Gasping for air suddenly while sleeping. Feeling tired after a night of rest. These aren’t just signs of a poor night’s sleep – they could be symptoms of obstructive sleep apnea.

Sleep apnea is a serious sleep disorder characterized by a repetitive collapse of the airway during sleep. Most people with sleep apnea don’t even know they have it – in fact, 80% of people with sleep apnea in the United States are undiagnosed, according to research published in the “American Journal of Epidemiology.”

Experts from the American Academy of Sleep Medicine (AASM) recommend most adults get at least seven hours of sleep each night without waking frequently. If you have untreated sleep apnea, healthy, uninterrupted sleep can be hard to achieve. When the airway collapses or becomes blocked while you sleep, it causes you to wake briefly – maybe with a snore or gasp for air – to unblock the airway.

Untreated sleep apnea can contribute to long-term health problems, including hypertension (high blood pressure), heart disease, stroke, Type 2 diabetes and depression. Overall quality of life can also suffer. It can lead to a decline in mood, lower work productivity, difficulty concentrating and making decisions and an increased likelihood of getting into a traffic accident due to sleepiness.

The disorder may even affect your family and relationships; snoring or poor sleep due to sleep apnea can keep your family members up at night, affect your mood with others and impact your general decision-making. Consider this additional information about sleep apnea from Count on Sleep, a collaborative awareness program led by the AASM.

Signs and symptoms of OSA:

Snoring or noisy breathing
Stopping breathing while asleep
Waking up gasping or choking
Restless sleep or waking up tired and groggy after a full night’s sleep
Insomnia
Waking up frequently to use the bathroom
Having headaches in the morning
Feeling sleepy or falling asleep during the day
Having difficulty with memory or concentrating
Mood changes or irritability
Drowsy driving

Risk factors for OSA:

Overweight or obesity (BMI of more than 30)
High blood pressure
Neck size of more than 17 inches for men; 16 inches for women
Coronary artery disease (a type of heart disease) or heart attack
Atrial fibrillation or other heart rhythm problems
Congestive heart failure
Type 2 diabetes
Stroke
Daytime sleepiness

If you think you may have undiagnosed sleep apnea, talk to your doctor about your signs, symptoms, risk factors and concerns. If friends or family members exhibit these symptoms, urge them to talk to a doctor.

Your doctor may screen or test you for sleep apnea, which could include an at-home sleep test or sleep study at an accredited sleep center. If diagnosed, treatment options include continuous positive airway pressure (CPAP) therapy, oral appliance, surgery or lifestyle changes.

Learn more about how sleep apnea affects health and take a short quiz to see if you may be at risk at countonsleep.org.

Sleep Apnea Treatments

When followed properly, sleep apnea treatment improves breathing, sleepiness and quality of life. Some people may find the disorder improves through lifestyle changes such as losing weight, sleeping on their side or quitting smoking or drinking alcohol. Most of the time, however, other treatment options are necessary, such as:

CPAP
The most common and recognized treatment for sleep apnea, a CPAP machine provides a steady stream of air to keep your airway open throughout the night.

Oral appliance therapy
Similar to a mouthguard, an oral appliance can be worn at night to prevent the airway from collapsing by moving the jaw forward.

Surgery
If lifestyle changes, CPAP or oral appliance therapy don’t work, there are surgical options to treat sleep apnea. They include upper airway stimulation, which uses an implanted device to stimulate a nerve that controls the tongue, moving it forward while you sleep.

Photos courtesy of Shutterstock

SOURCE:
American Academy of Sleep Medicine

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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Lifestyle

Important Recall Alert: Expanded Produce Recall Due to Listeria Concerns

Published

4 days ago

July 23, 2024

Charles Elliot, Daily News Staff

In a significant public health alert, the Ohio Department of Agriculture (ODA) has announced an expanded recall of fresh produce supplied by Wiers Farm Inc., based in Huron County. This comes amidst growing concerns about potential listeria contamination, prompting vigilance among consumers shopping at select retailers, including Walmart, Aldi, and Kroger stores across Ohio and several other states.

people at supermarket. recall — Photo by Sebastián Mera Jaramillo on Pexels.com

What You Need to Know

On July 22, 2024, Wiers Farm Inc. expanded its voluntary recall to include additional produce items that were packed between July 5 and July 12. While there have been no reported illnesses or consumer complaints to date, the ODA is taking proactive measures to ensure public safety.

Affected Products

The recall includes a variety of retail packaged items and bulk produce sold at various grocery chains. Here’s a comprehensive list of the impacted products:

Retail Packaged Items

Sold at select Walmart stores in multiple states:

Wiers Farm Bagged Poblano – UPC 073064202581 – 16 oz bag
Wiers Farm Bagged Cubanelle – UPC 073064201836 – 16 oz bag
Wiers Farm Bagged Green Beans – UPC 073064200846 – variable weight bag
Wiers Farm Bagged Salad Cucumber – UPC 073064459619 – 2 lb. bag
Wiers Farm Bagged Serrano – UPC 073064201829 – 4 oz bag
Wiers Farm Organic Bell Pepper – UPC 073064201416 – 2 count tray
Wiers Farm Organic Cucumber – UPC 073064201423 – 2 count tray
Wiers Farm Organic Yellow Squash – UPC 073064201447 – 2 count tray
Wiers Farm Organic Zucchini Squash – UPC 073064201430 – 2 count tray

Sold at Aldi stores in Ohio and nearby states:

Freshire Farms Bagged Green Beans – 16 oz bag
Freshire Farms Bagged Jalapenos – 8 oz bag

Bulk Retail Items (sold individually or by the pound)

Anaheim peppers
Cilantro (sold in bunches)
Cubanelle peppers
Whole cucumbers
Green beans
Green Bell Pepper
Habanero peppers
Hungarian Wax peppers
Jalapeno peppers
Mustard Greens (sold in bunches)
Poblano peppers
Serrano peppers
Tomatillos

In Ohio, these bulk items were distributed to Walmart, Kroger, Save-a-Lot, and local food banks in Cleveland and Youngstown.

What Should Consumers Do?

The ODA is urging consumers who may have purchased any of the listed products to discard them immediately. It’s crucial to stay informed, as listeria monocytogenes can lead to serious health issues, particularly in vulnerable populations such as pregnant women, the elderly, and those with weakened immune systems. Symptoms of listeriosis can include fever, muscle aches, and gastrointestinal distress—anyone experiencing these symptoms after consuming the recalled products should seek medical attention promptly.

Commitment to Safety

Wiers Farm Inc. has expressed its dedication to resolving this situation and ensuring the safety of its products. The ODA is actively investigating the matter, a response initiated after potential contamination was flagged during routine testing by the Michigan Department of Agriculture and Rural Development.

Stay Informed

For further inquiries or concerns, consumers can reach out to Wiers Farm at 419-933-2161. It’s essential to stay updated on recalls and food safety alerts to protect your health and the health of your loved ones.

As we navigate through these recalls, let’s remain vigilant and prioritize food safety to ensure a healthy dining experience for everyone. Remember, when in doubt, it’s better to be safe than sorry—check your pantry and fridge today!

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fitness

Canada’s largest fitness conference brings together global health & fitness experts August 9 & 10

Published

4 days ago

July 23, 2024

Daily News Staff

TORONTO /CNW/ – The biggest names in fitness and wellness will gather in downtown Toronto this summer for the canfitpro Global Conference and Trade Show August 9 and 10. Hundreds of fitness experts, professionals and consumers will take part in the largest fitness conference and trade show in Canada to learn the latest nutrition, wellness and exercise trends.

Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9271551-canadas-largest-fitness-conference-canfitpro-global-august-2024/

Check out canfitpro Global Conference & Trade Show Aug 9-10, 2024

This year’s conference will include topical sessions on training for athletes of all ages, accessible fitness for different abilities, managing mindset and mental outlook, nutrition for better quality of life, fitness trends and therapeutic approaches to physical activity. Participants can watch the Pickleball Ontario Championships on site, join their favourite classes as part of the Les Mills Experience fitness festival, and tour booths from 100+ leading companies showcasing the latest wellness technology, nutrition, apparel and equipment. Anyone can attend.

Click here for a full schedule of in-person and online sessions. Some session highlights include:

Friday, August 9
Opening ceremonies
Hamza Khan, global expert in the future of work and people-first leadership.
Learn how to adapt and thrive in today’s fragmented work environment. Hamza Khan will share his ideas on purposeful productivity, transcend burnout culture, and embrace constant change.

Training styles for neurodivergent athletes
Christine Conti, fitness coach and educator, chronic disease specialist.
As a personal trainer and triathlon/Iron Man guide for athletes with autism, Down syndrome and other neurodivergent disorders, Christine Conti champions advanced visual, tactile and auditory coaching techniques that suit every learning style, helping all athletes reach their peak performance.

Food over 40: Men’s guide to boosting testosterone, muscle and confidence
Funk Roberts, nutrition and fitness expert for men over 40, owner of Funk Roberts Fitness
Nutrition for men over 40 is not about calories, macros or any restrictive fad diet. Funk Roberts teaches men how to implement an effective and sustainable nutrition system that naturally increases testosterone, boosts metabolism, builds muscle and increases energy.

Saturday, August 10
Hormone toxicity: Taking back control during perimenopause and menopause
Kelly Nolan, pharmacist, women’s health expert
Major shifts in body chemistry during perimenopause and menopause can wreak havoc emotionally and physically with a dramatic shift in body image and unexpected symptoms from ongoing anxiety to high fatigue and brain fog affecting our work performance. Kelly Nolan will explore how to detoxify to balance hormones naturally with the goal of optimal health, weight release and disease prevention.

Four generations, one passion for fitness
Sal Pellegrino, international fitness expert and presenter
For the first time, four generations are actively working out in the gym at one time. But not all generations want the same thing. From in-gym social centres to outdoor fitness to tranquil recovery spaces, Sal Pellegrino will share his research into what motivates each generation and what we’ll see in our neighbourhood gyms in the months and years to come.

Photo opportunities:

Watch fast-paced matches and learn Pickleball basics from Ontario’s best players
Join hundreds of fitness enthusiasts for a giant workout led by New Zealand superstar instructors at the Les Mills Experience
Learn boxing moves from George Foreman III or try Face Yoga for a natural facelift with Sophia Ha
Take a cold plunge, enjoy a Cryo Lounge chair and sweat through the latest workouts including Joga, Warrior Combat, Socacize….even a step class with R&B soul singer Jully Black.

About canfitpro
canfitpro is the largest provider of education in the Canadian fitness industry. Founded in 1993, canfitpro delivers accessible, quality education, certifications, conferences, trade shows, and membership services. canfitpro’s 60,000 members include some of the world’s finest fitness professionals, health club operators, industry suppliers and fitness consumers. (canfitpro.com)

SOURCE canfitpro