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FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use

FDA issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status.

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Agency Continues to Encourage Sponsor Applications for Over-the-Counter Naloxone Products

Agency Continues to Encourage Sponsor Applications for Over-the-Counter Naloxone Products 

Today, the U.S. Food and Drug Administration issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status. Naloxone is a medicine that can help reduce opioid overdose deaths and when administered timely, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects.

“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Robert M. Califf, M.D. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”

The Federal Register notice includes a preliminary assessment that certain naloxone drug products–up to 4 milligrams (mg) nasal spray and up to 2 mg autoinjector for intramuscular (IM) or subcutaneous (SC) use–may be approvable as safe and effective for nonprescription use. This preliminary assessment is intended to facilitate development and approval of nonprescription naloxone products; however, it is not a final determination that certain naloxone drug products are safe and effective for nonprescription use, and it does not mandate an immediately effective switch to nonprescription/over-the-counter (OTC) availability for naloxone.

To make its final determination, the FDA needs additional data, such as product-specific data on the nonprescription user interface design, including packaging and labeling. These data would usually be submitted to the agency in an application for a proposed nonprescription naloxone product.

By issuing this notice, the FDA is making application holders of certain prescription naloxone drug products aware of the preliminary assessment and the possibility that the agency may make a conclusive determination, through approval of a nonprescription naloxone drug product, that such products are safe and effective for use without a prescription. 

The notice does not cover all naloxone products, as more data are needed on the safety and efficacy for nonprescription use of higher dose naloxone products and naloxone supplied in other presentations (including vials, ampules or syringes without integrated needles) before a preliminary assessment with respect to those products can be reached. The notice requests comments from the public on whether there is data to support safe and effective nonprescription use of higher dose naloxone products and on potential consequences of a switch from prescription to nonprescription status.

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Over the last several years, the FDA has taken a number of steps to improve access to naloxone products. In September, the agency issued an immediately in effect guidance to clarify that certain Drug Supply Chain Security Act requirements do not apply to distribution of naloxone to harm reduction programs during the Opioid Public Health Emergency. Additional efforts include development of a model Drug Facts Label, which is required for OTC drug products, with easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products; requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to add new recommendations about naloxone to their prescribing information; and extending the shelf life of naloxone nasal spray from 24 months to 36 months. 

The FDA continues to make progress implementing the new FDA Overdose Prevention Framework – our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths. The agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose, and death in the U.S. through the four priorities of the framework, including: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

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Popular Nasal Decongestant Falls Short: FDA Advisers Question Efficacy

FDA questions effectiveness of popular nasal decongestant phenylephrine, raising concerns about congestion relief.

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decongestant


In a surprising turn of events, government experts have cast doubt on the effectiveness of the leading decongestant found in popular over-the-counter medications like Sudafed and Dayquil. A recent review conducted by the Food and Drug Administration (FDA) found that the main drug ingredient, phenylephrine, offers no significant relief from nasal congestion. This revelation raises concerns among millions of Americans who rely on these medications for congestion relief.

Phenylephrine became the primary ingredient in over-the-counter decongestants after pseudoephedrine, an older ingredient, was moved behind pharmacy counters due to its potential for illegal drug processing. However, the FDA’s outside advisers unanimously voted against the efficacy of phenylephrine, prompting a reevaluation of its effectiveness. Despite phenylephrine-based versions dominating the market, accounting for four-fifths of the $2.2 billion oral decongestant market, the FDA’s conclusions suggest a need to reconsider their availability.

The FDA review identified significant flaws in the original studies that supported phenylephrine’s approval. These studies, conducted in the 1960s and 1970s, were deemed inadequate by modern standards. Furthermore, three recent, well-conducted studies by reputable pharmaceutical companies found no discernible difference between phenylephrine medications and placebos in relieving congestion. This raises concerns about the effectiveness of phenylephrine, which has relied on outdated research.

The FDA’s advisory panel’s unanimous vote against phenylephrine’s effectiveness could lead to regulatory action requiring drugmakers like Johnson & Johnson and Bayer to withdraw their phenylephrine-based oral decongestants from store shelves. This move may force consumers to opt for behind-the-counter pseudoephedrine products or phenylephrine-based nasal sprays and drops. However, it would necessitate extensive education efforts by the FDA, pharmacists, and drugstores to inform consumers about alternative options for treating congestion.

The Consumer Healthcare Products Association, representing nonprescription drugmakers, argued that the recent studies have limitations and advocated for continued “easy access” to phenylephrine. However, the FDA review highlighted the shortcomings of the original studies and the lack of modern scientific evidence supporting phenylephrine’s efficacy. Balancing public health concerns and consumer access will be a crucial challenge for regulators moving forward.

The FDA’s recent review has cast doubt on the effectiveness of phenylephrine, the key ingredient in popular nasal decongestants. This finding prompts a reevaluation of treatment options for nasal congestion and calls for further research to provide effective relief for individuals in need.

Check out the article from the Associated Press: https://apnews.com/article/sudafed-decongestants-phenylephrine-pseudoephedrine-fda-0f140bafae9a500c5fba05fe764ecb66

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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Important Recall Alert – Listeria Contamination in Meal Kits

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mouthwatering tacos in macro shot photography. Listeria
Photo by Jeswin Thomas on Pexels.com

In recent news, Reser’s Fine Foods has issued a recall on several of its popular meal kits due to potential contamination with Listeria monocytogenes, a harmful bacteria known to cause food poisoning. This recall was prompted by the inclusion of chicken from their ingredient supplier, BrucePac, which has also been recalled due to contamination concerns.

What Products Are Affected?

The affected meal kits include a variety of delicious options that many consumers may have purchased. These products consist of:

  • Taco Meal Kits
  • Enchilada Meal Kits
  • Quesadilla Meal Kits
  • Stir Fry Meal Kits
  • Salad Meal Kits

All of these products have been classified under a Class II recall by the U.S. Food and Drug Administration (FDA), indicating that while exposure may lead to temporary or medically reversible health consequences, the probability of serious adverse health effects is remote.

Understanding Listeria

Listeria monocytogenes is a bacterium that can lead to listeriosis, a serious infection typically caused by eating contaminated food. Symptoms can include fever, muscle aches, and gastrointestinal issues. Pregnant women, newborns, older adults, and individuals with weakened immune systems are particularly vulnerable to severe outcomes from listeriosis.

What Should Consumers Do?

If you have purchased any of the affected meal kits, it is crucial to check the packaging for any recall notices. Consumers should discard any recalled products or return them to the place of purchase for a refund. It is also advisable to stay informed by checking official announcements from the FDA and Reser’s Fine Foods regarding the recall.

Stay Informed

For the latest updates and more detailed information about this recall, visit the following resources:

Stay vigilant and prioritize your health by being aware of food recalls and potential safety issues. Your safety is paramount, so always make sure to stay informed about the food products you consume.

Related link:

https://www.newsweek.com/taco-meal-kit-recall-30-states-fda-1978552

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.

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Is There an E. Coli Outbreak at McDonald’s? What You Need to Know

McDonald’s faces an E. coli outbreak linked to Quarter Pounders, with 75 cases reported. The company is investigating potential onion contamination and prioritizing customer safety.

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E. coli outbreak


In the fast-paced world of fast food, health and safety are paramount. Recently, McDonald’s has been at the center of an alarming E. coli outbreak linked to their popular Quarter Pounders. With at least 75 reported cases across 13 states, including serious hospitalization and even a death, many consumers are understandably concerned. Let’s break down the situation, what officials are saying, and how McDonald’s is responding to the crisis.

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🚨 E. coli outbreak linked to McDonald’s Quarter Pounders! Stay safe & report any symptoms. Food safety is a top priority. 🍔 FoodSafety #ecolioutbreak2024 https://stmdailynews.com ♬ original sound – STMDailyNews – STMDailyNews

The Details of the Outbreak

Reports have confirmed that this E. coli outbreak is associated with Quarter Pounders sold across various McDonald’s locations. As of now, Colorado and Montana have recorded the highest number of illnesses, causing health officials to raise the alarm. The symptoms of E. coli infection can be severe and include stomach cramps, diarrhea, and vomiting, which can lead to life-threatening complications, especially in vulnerable populations.

AdobeStock 629889305 1

Possible Cause: Onions?

Amidst this distressing news, McDonald’s has identified a potential link to onions used in their Quarter Pounder recipe. While investigations are ongoing, the company is taking proactive measures by gradually reintroducing the Quarter Pounder to their menu without the traditional onions. This decision reflects their commitment to ensuring customer safety while addressing supply issues that may have arisen from the outbreak.

McDonald’s Response

In light of the ongoing investigation, McDonald’s has expressed its dedication to maintaining high food safety standards. They have collaborated closely with health officials, including the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), to trace the source of the contamination and prevent further incidents.

As they navigate this situation, the fast-food giant is emphasizing transparency with their customers. They have urged people to stay informed through official communication channels and monitor updates about the progress of the outbreak and safety measures being undertaken.

Consumer Safety: What Can You Do?

As the situation unfolds, it is essential for consumers to remain vigilant about their food choices:

  1. Stay Updated: Follow news reports and health advisories to keep track of the latest developments regarding this outbreak and any additional safety alerts.
  2. Practice Good Hygiene: Always wash your hands before eating, and keep an eye on cleanliness when dining out.
  3. Consider Menu Options: If you’re concerned about the outbreak, consider ordering items that do not contain ingredients linked to health risks or opt for menu items that have been specifically noted as safe.
  4. Know the Symptoms: Familiarize yourself with the signs of E. coli infection, and if you or someone you know experiences severe symptoms following a visit to McDonald’s, seek medical attention immediately.

The recent E. coli outbreak tied to McDonald’s Quarter Pounders has undoubtedly raised concerns among consumers, but the company is actively working to address the situation and safeguard the health of its patrons. While it’s human nature to worry about food safety, especially with such a concerning issue at hand, it’s also important to empower ourselves with knowledge and the right precautions.

As McDonald’s rolls out their menu changes, we hope that they can swiftly resolve this situation, ensuring that everyone can enjoy their meals with renewed confidence. Let’s all take a moment to prioritize food safety in our daily dining habits, and keep the conversation going around this crucial topic. Always stay informed, stay safe, and enjoy your meals wisely!

Read the release from McDonald’s corporate news site https://corporate.mcdonalds.com/corpmcd/our-stories/article/always-putting-food-safety-first.html

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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.

https://stmdailynews.com/food-and-drink/

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