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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.

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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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Food and Beverage

Cinnamon, spice and ‘everything nice’ – why lead-tainted cinnamon products have turned up on shelves, and what questions consumers should ask

A Consumer Reports investigation revealed alarming lead levels in ground cinnamon, prompting concerns over safety, especially for children and pregnant women.

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It’s important to buy cinnamon from reputable dealers. Anjelika Gretskaia/Moment via Getty Images

Katarzyna Kordas, University at Buffalo

Spices bring up feelings of comfort, cultural belonging and holidays. They can make our homes smell amazing and our food taste delicious. They can satisfy our cravings, expand our culinary horizons and help us eat things that we might normally dislike. Spices have health-enhancing properties and, in medicine, have been used to heal people since the ancient times.

Recently, however, spices have been getting a bad rep.

In September 2024, Consumer Reports, a nonprofit organization created to inform consumers about products sold in the U.S., investigated more than three dozen ground cinnamon products and found that 1 in 3 contained lead levels above 1 part per million, enough to trigger a recall in New York, one U.S. state that has published guidelines for heavy metals in spices.

The Food and Drug Administration issued three alerts throughout 2024, warning consumers about lead in certain brands of cinnamon products. Such notices rightfully put consumers on alert and have people wondering if the spice products they buy are safe – or not. https://www.youtube.com/embed/QxAwznMht8M?wmode=transparent&start=0 A Consumer Reports investigation of more than three dozen ground cinnamon products found that 1 in 3 contain lead levels above 1 part per million.

As an environmental epidemiologist with training in nutritional sciences, I have investigated the relationship between nutritional status, diets and heavy metal exposures in children.

There are several things consumers should be thinking about when it comes to lead – and other heavy metals – in cinnamon.

Why is lead found in cinnamon?

Most people are familiar with cinnamon in two forms – sticks and ground spice. Both come from the dried inner bark of the cinnamon tree, which is harvested after a few years of cultivation. For the U.S. market, cinnamon is largely imported from Indonesia, Vietnam, Sri Lanka, India and China.

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One way that lead could accumulate in cinnamon tree bark is when trees are cultivated in contaminated soil. Lead can also be introduced in cinnamon products during processing, such as grinding.

When ground cinnamon is prepared, some producers may add lead compounds intentionally to enhance the weight or color of the product and, thus, fetch a higher sale price. This is known as “food adulteration,” and products with known or suspected adulteration are refused entry into the U.S.

However, in the fall of 2023, approximately 600 cases of elevated blood lead levels in the U.S., defined as levels equal to or above 3.5 micrograms per deciliter – mostly among children – were linked to the consumption of certain brands of cinnamon apple sauce. The levels of lead in cinnamon used to manufacture those products ranged from 2,270 to 5,110 parts per million, indicating food adulteration. The manufacturing plant was investigated by the FDA.

Horizontal photo of cinnamon trees, with trunks in foreground.
Cinnamon trees in Zanzibar, Tanzania. Zanzibar is known the world over as the ‘spice islands.’ Dong Jianghui/Xinhua via Getty Images

More broadly, spices purchased from vendors in the U.S. have lower lead levels than those sold abroad.

There is some evidence that cinnamon sticks have lower lead levels than ground spice. Lead levels in ground cinnamon sold in the U.S. and analyzed by Consumer Reports ranged from 0.02 to 3.52 parts per million. These levels were at least 1,500 times lower than in the adulterated cinnamon.

There are no federal guidelines for lead or other heavy metals in spices. New York state has proposed even stricter guidelines than its current level of 1 part per million, which would allow the New York Department of Agriculture and Markets to remove products from commerce if lead levels exceed 0.21 parts per million.

What does it mean that ‘the dose makes the poison’?

The current FDA guideline on daily intake of lead from diets overall is to limit lead intake to 2.2 micrograms per day for children. For women of reproductive age, this value is 8.8 micrograms.

The lead dose we are exposed to from foods depends on the level of lead in the food and how much of that food we eat. Higher doses mean more potential harm. The frequency with which we consume foods – meaning daily versus occasionally – also matters.

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For spices like cinnamon, the amount and frequency of consumption depends on cultural traditions and personal preference. For many, cinnamon is a seasonal spice; others use it year-round in savory dishes or sauces.

Cinnamon is beloved in baked goods. Take a cinnamon roll recipe calling for 1.5 tablespoons (slightly less than 12 grams) of the spice. If a recipe yields 12 rolls, each will have around 1 gram of cinnamon. In the Consumer Reports investigation, some cinnamon products were classified as “okay to use” or “best to use.”

The highest value of lead in cinnamon products in the “okay to use” category was 0.87 parts per million, and in the “best to use” category, it was 0.15 parts per million. A child would have to consume 2.5 or more rolls made with the “okay to use” cinnamon to exceed the FDA guideline on limiting lead intake from foods to 2.2 micrograms per day, assuming that no other food contained lead. To exceed this guideline with “best to use” cinnamon, a child would have to eat 15 or more rolls.

Stick cinnamon and cinnamon powder on rustic wooden table.
Research suggests that ground cinnamon contains higher lead levels than cinnamon sticks. Helen Camacaro/Moment via Getty Images

Can cinnamon contribute to elevated blood lead levels?

Because of lead’s effects on development in early life, the greatest concern is for exposure in young children and pregnant women. Lead is absorbed in the small intestine, where it can latch onto cellular receptors that evolved to carry iron and other metals.

The impact of a contaminated spice on a person’s blood lead level depends on the dose of exposure and the proportion of lead available for intestinal absorption. For several spices, the proportion of available lead was 49%, which means that about half of the lead that is ingested will be absorbed.

Lead absorption is higher after a fast of three hours or more, and skipping breakfast may contribute to higher blood lead levels in children.

People who have nutritional deficiencies, such as iron deficiency, also tend to absorb more lead and have higher blood lead levels. This is because our bodies compensate for the deficiency by producing more receptors to capture iron from foods. Lead takes advantage of the additional receptors to enter the body. Young children and pregnant women are at higher risk for developing iron deficiency, so there is good reason for vigilance about lead in the foods they consume.

Studies show that among children with lead poisoning in the U.S., contaminated spices were one of several sources of lead exposure. Studies that estimate blood lead levels from statistical models suggest that consuming 5 micrograms of lead or more from spices daily could substantially contribute to elevated blood lead levels.

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For occasional or seasonal consumption, or lower levels of contamination, more research is needed to understand how lead in spices would affect lead levels in the blood.

For people who have other sources of lead in their homes, jobs or hobbies, additional lead from foods or spices may matter more because it adds to the cumulative dose from multiple exposure sources.

How to test for elevated blood lead levels

The Centers for Disease Control and Prevention recommends that children at risk for lead exposure get a blood lead test at 1 and 2 years of age. Older children can also get tested. Finger-prick screening tests are often available in pediatric offices, but results may need to be confirmed in venous blood if the screening result was elevated.

Adults in the U.S. are not routinely tested for lead exposure, but concerned couples who plan on having children should talk to their health care providers.

What to consider when using or buying cinnamon or other spices

If the product is on an FDA Alert or the Consumer Reports “don’t use” list, discard it.

Other questions to consider are:

  • Does your household use spices frequently and in large amounts?
  • Do young children or pregnant women in your household consume spices?
  • Do you typically consume spices on breakfast foods or beverages?

If the answer to any of these questions is yes, then buy good-quality products, from large, reputable sellers. Think about using cinnamon sticks if possible.

And continue to enjoy spices!

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Katarzyna Kordas, Associate Professor of Epidemiology and Environmental Health, University at Buffalo

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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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FDA CDC News

Seafood Recall: Important Information on Hannaford Seafood Salads

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seafood based dish served on white plate
Photo by Valeria Boltneva on Pexels.com

In early November, the U.S. Food and Drug Administration (FDA) announced a Class II recall concerning Hannaford Seafood Salads, affecting over 1,600 units across five states: Maine, New Hampshire, Vermont, Massachusetts, and New York. The recall, initiated on October 31, was due to a mislabeling incident that poses a significant risk to consumers with soy allergies.

Understanding the Class II Risk Level

The FDA has classified this recall as a Class II risk, indicating that exposure to the affected products may cause “temporary or medically reversible adverse health consequences.” However, the risk of experiencing serious health consequences remains “remote.” Despite this classification, consumers with an allergy or severe sensitivity to soy must take this recall seriously, as they could face life-threatening allergic reactions if they consume the mislabeled salads.

What Happened?

The problem arose when the printer responsible for the salad labels provided Elevation Foods, the manufacturer of the salads, with labels that did not accurately reflect the current product formulation. Instead of the correct labels, the printer mistakenly issued labels meant for an upcoming formulation change. As a result, the affected salads may contain undeclared hydrolyzed soy protein, a known allergen that must be clearly stated on product labels to protect consumer safety.

Product Details

The implicated Hannaford Seafood Salads were distributed between October 25 and 29, and they feature use-by dates of November 13 and 14. Consumers can find these dates printed on the lid of the containers. Following the recall announcement, all affected products were promptly removed from store shelves.

Health Risks Associated with Soy Allergies

For individuals with soy allergies, the immune system mistakenly identifies soy proteins as harmful invaders, leading to a range of symptoms that can vary in severity. Common reactions include stomach issues, coughing, itching, wheezing, vomiting, hives, and difficulty breathing. In severe cases, these reactions can escalate to life-threatening conditions, such as anaphylaxis.

To mitigate risks, those with soy allergies are advised to carry an epinephrine injection (Epi-Pen) to counteract severe allergic reactions swiftly.

What Should Consumers Do?

Customers who purchased Hannaford Seafood Salads before the recall are urged not to consume the products. Instead, they can return them to the store where they made the purchase for a full refund. Elevation Foods has not reported any known cases of illness related to these salads, but consumer safety remains a top priority.

Conclusion

This seafood salad recall serves as a crucial reminder about the importance of accurate labeling, especially when it comes to potential allergens. Consumers should remain vigilant and informed about the products they purchase, particularly if they have food allergies. Stay safe and always check your labels!

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Related Links:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/elevation-foods-issues-recall-due-undeclared-soy-hannaford-seafood-salad

https://www.newsweek.com/seafood-salad-recall-update-fda-risk-level-hannaford-1992294

At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.

Visit our Food & Drink section to get the latest on Foodie News and recipes, offering a delightful blend of culinary inspiration and gastronomic trends to elevate your dining experience.

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Urgent Dog Treat Recall: Carolina Prime Pet Issues Warning Due to Salmonella Risk

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tan and white short coat dog laying down in a brown wooden floor. Dog treat recall
Photo by Bruno Cervera on Pexels.com

Dog Treat Recall

In a recent announcement that has concerned dog owners across the Southeastern, Midwestern, and Mid-Atlantic regions of the United States, the FDA has reported a recall of “Hollywood Feed Carolina Made Chicken Chips” dog treats manufactured by Carolina Prime Pet, Inc. of Lenoir, North Carolina. This recall, affecting approximately 400 bags of these popular dog treats, is attributed to the potential risk of Salmonella contamination.

Why Is This Recall Important?

While there have been no reported illnesses linked to the consumption of these chicken chips, the safety of pets—and by extension, their human companions—is paramount. Salmonella, a bacteria that can cause severe gastrointestinal distress in animals and humans alike, can be particularly dangerous for pets, leading to symptoms such as vomiting, diarrhea, and lethargy. For individuals, Salmonella can also result in serious health complications, especially in young children, elderly adults, or those with weakened immune systems.

@stmblog

🚨🍖 Important: Carolina Prime Pet is recalling dog treats due to Salmonella risk! Check your pantry and stay safe! 🐾 #DogSafety #Recall ♬ original sound – STMDailyNews

Details of the Recall

The recall specifically pertains to 16-ounce bags of “Hollywood Feed Carolina Made Chicken Chips” that carry the lot number 20051324L2 and an expiration date of 11/13/25. Consumers can easily identify the affected product by checking the back of the packaging, which features a distinctive purple-and-black design. The recall extends to retail locations across 19 states, including:

  • Alabama
  • Arkansas
  • Florida
  • Georgia
  • Illinois
  • Indiana
  • Kansas
  • Kentucky
  • Louisiana
  • Michigan
  • Mississippi
  • Missouri
  • North Carolina
  • Ohio
  • Oklahoma
  • Pennsylvania
  • South Carolina
  • Tennessee
  • Texas

For those who purchased the treats online, they were also available on the company’s website at www.hollywoodfeed.com.

What Should Consumers Do?

Carolina Prime Pet, Inc. has advised consumers to check their homes for the affected product. If your dog treats match the recalled lot number and expiration date, it is crucial not to feed them to your pet. Instead, return the products to the place of purchase for a full refund. For those who have questions or need more information, the company encourages contacting their customer service.

Final Thoughts

As pet owners, it is our responsibility to stay informed about the products we give our furry friends. The safety of our pets is essential, and recalls like these serve as a reminder to always check product packaging and stay updated on food safety announcements. If you have any concerns about your pet’s health or have noticed any unusual symptoms after consuming potentially contaminated food, it is advisable to consult with a veterinarian immediately.

Stay alert, stay informed, and together we can ensure the safety and well-being of our beloved pets.

Related links:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/carolina-prime-pet-inc-recalls-hollywood-feed-carolina-made-chicken-chips-because-possible

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https://www.hollywoodfeed.com

STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world. https://stmdailynews.com/


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