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FDA Approval of Nonsteroidal Treatment for Duchenne Muscular Dystrophy

Breaking news! FDA approves Duvyzat for Duchenne Muscular Dystrophy, a nonsteroidal treatment providing hope for patients and families. #DMD #FDAApproval

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Breaking news in the medical world! The U.S. Food and Drug Administration has just approved Duvyzat (givinostat), an oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is making history as the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. This is a significant milestone in the treatment of this devastating disease.

DMD, being the most common childhood form of muscular dystrophy, primarily affects males. It is a neurological disorder that leads to progressive muscle weakness due to a lack of dystrophin, a muscle protein. Over time, the muscles deteriorate, causing difficulties with walking, muscle strength, and eventually leading to breathing problems and early death. However, with advancements in treatment, the life expectancy for individuals with DMD has been steadily increasing, with some patients surviving beyond 30 years.

Duvyzat is a histone deacetylase (HDAC) inhibitor that targets pathogenic processes to reduce inflammation and loss of muscle in patients with DMD. Its efficacy for the treatment of DMD was evaluated in an 18-month phase 3 study involving a randomized, double-blind, placebo-controlled trial. The primary endpoint of the study was the change in muscle function, measured by the time it took patients to climb four stairs. Patients treated with Duvyzat showed a statistically significant reduction in the decline of muscle function compared to placebo.

Another measure of efficacy was the change in physical function assessed by the North Star Ambulatory Assessment (NSAA), a scale commonly used to rate motor function in boys with DMD who can still walk. Patients treated with Duvyzat experienced less worsening in their NSAA scores after 18 months, compared to those on placebo.

Like any medication, Duvyzat does come with some potential side effects. The most common ones reported were diarrhea, abdominal pain, a decrease in platelets, nausea/vomiting, an increase in triglycerides, and fever. It’s important for healthcare providers to evaluate a patient’s platelet counts and triglyceride levels before prescribing Duvyzat. Patients with low platelet counts should not take the drug. Monitoring of platelet counts and triglycerides throughout treatment will help determine if any dosage adjustments are needed.

Healthcare professionals should also be aware that Duvyzat may cause QTc prolongation, which can increase the risk of irregular heartbeats. It’s crucial for patients taking other medications known to cause QTc prolongation or with certain types of heart disease to avoid taking Duvyzat.

The recommended dosage of Duvyzat is determined by the patient’s body weight, and it should be taken orally twice daily with food.

The approval of Duvyzat was granted to Italfarmaco S.p.A., and it received priority review, fast-track designation, as well as orphan drug and rare pediatric disease designations from the FDA. This demonstrates the agency’s commitment to advancing the development of new therapies for DMD and its recognition of the urgent need for effective treatments.

This milestone approval represents hope and progress for individuals and families affected by DMD. It provides another treatment option to help reduce the burden of this progressive and debilitating disease, regardless of the specific genetic mutation. With continued advancements in medical research and the dedication of organizations like the FDA, we are moving closer to a future where individuals with DMD can lead healthier lives.

As always, it’s important to consult with healthcare professionals for more information and guidance regarding Duvyzat and its suitability for individual cases. Let’s celebrate this achievement in medical science and look forward to more groundbreaking developments in the treatment of Duchenne Muscular Dystrophy.

Source: FDA

Related Information

  • Duchenne muscular dystrophy – About the Disease – Genetic and Rare Diseases Information Center
  • The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Urgent Recall Notice: Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies

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Recall Notice


Recall Notice:

Recently, the FDA issued an urgent recall notice for Diamond Shruumz-Brand Chocolate Bars, Cones, and Gummies due to reports of severe illnesses associated with consuming these products. This blog post aims to provide you with essential information about the ongoing investigation and steps you can take to protect yourself and your loved ones.

Recall Details:
The FDA advises against eating, selling, or serving any flavor of Diamond Shruumz-Brand Chocolate Bars, Cones, and Gummies. These products have been linked to a range of severe symptoms including seizures, central nervous system depression, abnormal heart rates, and nausea. The recall affects all flavors of Diamond Shruumz-Brand products, including Microdosing Chocolate Bars, Infused Cones, and Micro-Dose/Mega-Dose Gummies.

Affected Stores:
The Diamond Shruumz-Brand products were previously available online and at various retail locations nationwide, including smoke/vape shops and stores selling hemp-derived products like CBD or delta-8 THC. If you have purchased any of these products, it’s crucial to stop consumption immediately.

Current Status:
The investigation is ongoing, with updates being provided as new information becomes available. It is essential to take proactive steps to ensure your safety and the safety of those around you.

Recommendations:

  • Do not consume any Diamond Shruumz-Brand products. Check your home for these items and either discard them or return them to the company for a refund.
  • Parents and caregivers should be vigilant as these products may appeal to children and teens. Educate them about the dangers and ensure that these items are not consumed.
  • Retailers are urged not to sell or distribute any Diamond Shruumz-Brand products and to follow the proper recall procedures.

Health Warning:
If you or someone you know experiences symptoms after consuming Diamond Shruumz-Brand products, contact a healthcare provider immediately. You can also reach out to the Poison Help Line at 1-800-222-1222 for assistance.

Case Updates:
As of July 1, 2024, a total of 48 illnesses have been reported in 24 states, with 27 individuals requiring hospitalization and one potentially associated death under investigation. It is crucial to stay informed and take necessary precautions to avoid any further health risks.

Recall Notice


Your health and safety are of utmost importance. By following the FDA’s recall notice and taking appropriate actions, you can help prevent further illnesses related to Diamond Shruumz-Brand Chocolate Bars, Cones, and Gummies. Stay informed, stay safe, and prioritize your well-being and that of your community.

Remember, if you have any concerns or experience symptoms, do not hesitate to seek medical help promptly. Together, we can navigate through this challenging situation and protect each other from potential harm.

Who to Contact

Consumers who have symptoms should contact their health care provider to report their symptoms and/or the Poison Help line to receive care.

To report a complaint or adverse event (illness or serious allergic reaction), you can

Submit Questions/Get Assistance

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Source: FDA

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Health Alert: Classic Delight Sandwiches May Pose a Risk of Contamination

Potential contamination alert: Classic Delight sandwiches recalled due to Listeria monocytogenes risk. Take necessary precautions.

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Classic Delight sandwich recall due to Listeria monocytogenes contamination risk
Fresh sub sandwich on white and wheat hoagies.(Adobe Stock)


In a recent public health alert, Classic Delight LLC, a food company based in St. Mary’s, Ohio, has announced a voluntary recall of certain individually wrapped sandwiches due to potential contamination with Listeria monocytogenes. This organism can result in severe infections, especially among vulnerable individuals. While no illness or adverse reactions have been reported thus far, the company is taking proactive measures to ensure consumer safety.

Details of the Recall:
The affected products, produced between May 11, 2023, and June 6, 2024, were distributed to several states, including Arkansas, California, Maryland, Missouri, Ohio, Pennsylvania, and Texas. These sandwiches may have made their way into food service distribution, convenience stores, and vending machines. To assist in identifying the recalled items, here is a list of the specific products:

  • 7060 Classic Delight Twin Chili Cheese Dog
  • 514713 Wakefield Charbroiled Cheeseburger
  • 311 Classic Delight Turkey Ham and Cheese Sub
  • 551697 Wakefield Ham Cheddar Pretzel Croissant
  • 314 Classic Delight Turkey Cheese Sub
  • 648899 Wakefield Chorizo Egg Ciabatta
  • 6731 Classic Delight Turkey Cheese Round
  • 806604 Wakefield Ham Egg Cheese Muffin
  • 6757 Classic Delight Twin Breaded Chicken Sliders
  • 806612 Wakefield Ham Egg Cheese Croissant
  • 7626 Classic Delight Breaded Chicken Waffle
  • 806620 Wakefield Bacon Egg and Cheese Bagel
  • 73131 Nutrisystem Turkey Sausage and Egg Muffin
  • 806638 Wakefield Sausage Egg and Cheese Biscuit
  • 176586 Wakefield Pretzel Bacon Angus Cheeseburger
  • 806646 Wakefield Sausage Egg and Cheese Muffin
  • 176594 Wakefield Southern Chicken Biscuit
  • 806653 Wakefield Bacon Cheeseburger
  • 195263 Wakefield Spicy Hawaiian Sliders
  • 806661 Wakefield Blazin Chicken
  • 514711 Wakefield Bacon Egg and Cheese Bagel
  • 806679 Wakefield Charbroiled Cheeseburger
  • 514712 Wakefield Sausage Egg and Cheese Biscuit
  • 806687 Wakefield Chicken and Cheese
  • 942821 Wakefield Sausage Egg Pancake

Reasons for Recall:
Classic Delight initiated the recall after routine environmental testing revealed the presence of Listeria monocytogenes. The company is actively collaborating with the U.S. Food & Drug Administration (FDA) to investigate the origin of the issue. As a precautionary measure, production of the affected products has been halted until the source of contamination is identified and resolved.

Action Steps for Consumers:
If you have purchased any of the recalled Classic Delight sandwiches, it is crucial to take immediate action to safeguard your health and well-being. Here’s what you need to do:

  1. Discard the affected products if they are still in your possession.
  2. For a full refund, return the recalled items to the place of purchase.
  3. Any concerns or queries can be directed to the Classic Delight Consumer Hotline at (419)-300-3202, Monday through Friday, 8:00 am to 3:00 pm Pacific Time. Alternatively, you may contact them via email at info@classicdelight.com.

Health and Safety Measures:
While there have been no reported cases of illness linked to these products thus far, it’s important to remain vigilant. Should you experience any symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, or diarrhea after consuming these sandwiches, contact your healthcare provider immediately.


Classic Delight’s voluntary recall underscores their commitment to ensuring the safety of consumers. By swiftly addressing the potential risk of Listeria monocytogenes contamination, Classic Delight is taking proactive steps to protect public health. Remember to check your refrigerators or storage areas for the listed products and follow the recommended actions to minimize any potential harm. Always prioritize your well-being and stay informed about food recalls to make educated choices about the food you consume.

Company Contact Information

Consumers:Classic Delight Consumer Hotline (419)-300-3202 info@classicdelight.com

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Press Release: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/classic-delight-llc-issues-public-health-alert-due-possible-health-risk

https://stmdailynews.com/category/lifestyle/health-and-wellness

About the FDA?

The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health by overseeing food safety, tobacco products, caffeine products, dietary supplements, pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products.

The FDA primarily enforces the Federal Food, Drug, and Cosmetic Act (FD&C) but also enforces other laws like Section 361 of the Public Health Service Act. This includes regulating lasers, cellular phones, and condoms, and controlling diseases in household pets and human sperm for assisted reproduction.

The FDA is led by the Commissioner of Food and Drugs, appointed by the President and confirmed by the Senate, reporting to the Secretary of Health and Human Services. Robert Califf is the current Commissioner as of 17 February 2022.

The FDA’s headquarters is in White Oak, Maryland, with 223 field offices and 13 laboratories across the US, including the Virgin Islands and Puerto Rico. Since 2008, the FDA has posted employees to various foreign countries like China, India, Costa Rica, Chile, Belgium, and the United Kingdom. (Wikipedia)

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Soft Drinks Recall: Undeclared Ingredients Pose Health Hazards

Recalled soft drinks by Charles Boggini Company contain undeclared ingredients, posing health hazards. Stay informed for a safer choice!

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In a recent development, the Food and Drug Administration (FDA) has issued a recall on three soft drink products produced by Charles Boggini Company. The recall was initiated by the company due to undeclared ingredients in their Pink Lemonade, Cola Flavoring Base, and Yellow Lemonade and Yellow Lemonade X. These undisclosed components have now been classified by their risk level, helping consumers make informed decisions regarding their health and wellbeing.

Understanding the Risk Levels:
The FDA classifies health hazards into three levels: Class I, Class II, and Class III. Class I indicates the most severe risk, where the product has the potential to cause “serious adverse health consequences or death.” Class II signifies that exposure or use of the product might result in temporary or medically reversible adverse health consequences. Class III denotes a situation where the product is unlikely to cause adverse health consequences.

Recall Details:
The recalled soft drinks include 28 gallons of Pink Lemonade, 2,723 gallons of the Cola Flavoring Base, and 112 gallons of Yellow Lemonade and Yellow Lemonade X. The Pink Lemonade and Cola Flavoring Base were classified as Class II health hazards, while the Yellow Lemonade and Yellow Lemonade X products received a Class III categorization. It’s important to note that these recalls were voluntary and initiated by Charles Boggini Company in March this year.

Undisclosed Ingredients:
The Pink Lemonade was found to contain undeclared FD&C Red No. 40, the Cola Flavoring Base contained undisclosed sulfites, and the Yellow Lemonade and Yellow Lemonade X contained undeclared FD&C Yellow No. 5.

FD&C Red No. 40:
FD&C Red No. 40, also known as E129, is a red dye used in a wide range of products worldwide. While various organizations agree that dietary exposure to this dye is generally not a health concern, some studies have suggested potential links to allergies, migraines, and mental disorders, particularly ADHD in children. Consequently, the FDA mandates that any product containing this dye must declare it as an ingredient. Failure to comply can lead to product recalls.

Sulfites:
Sulfites, commonly used as preservatives in food products, were found in the Cola Flavoring Base. Although the FDA requires sulfites to be declared in food products with a level over 10 ppm (parts per million), some individuals may have sensitivities to sulfites. These sensitivities can manifest as skin reactions, digestive issues, or respiratory problems.

FD&C Yellow No. 5:
The Yellow Lemonade and Yellow Lemonade X were found to contain FD&C Yellow No. 5, also called tartrazine or E102. This synthetic food dye is commonly used in soda, colored candy, and pastries. For individuals with asthma or an aspirin intolerance, allergic and intolerance reactions may occur.


Customer safety and well-being are of utmost importance, and the voluntary recall by Charles Boggini Company, along with FDA classifications of the health hazards posed by undeclared ingredients, demonstrates their commitment to consumer protection. By being aware of the potential risks associated with undisclosed ingredients, individuals can make informed choices and support a culture of transparency in the food and beverage industry.

Check out the article in Newsweek.

https://www.newsweek.com/fda-food-recall-soda-food-dye-sulfites-1907882

https://stmdailynews.com/category/food-and-beverage

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