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  • Broccoli Recall Considered Class I Due to ‘Deadly’ Listeria Risk, FDA Warns


    Broccoli is a great vegetable to have on hand for making delicious dishes like stir-fries, soups, and more. But if you have any broccoli in your freezer, check the label immediately as it may be the subject of a possibly deadly recall, per the U.S. Food and Drug Administration (FDA).

    On December 31, 2024, the FDA announced a recall of Braga Fresh’s washed and ready-to-eat 12-ounce bags of Marketside Broccoli Florets due to the possibility of Listeria monocytogenes contamination.

    In a notice published on January 27, 2025, the FDA labeled this a Class I recall, which is “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

    Listeria is a bacteria that can cause serious and sometimes fatal infections in young children, elderly people, and those with weakened immune systems. Symptoms of infection can include muscle aches, fatigue, fever, diarrhea, and vomiting, the Centers for Disease Control and Prevention (CDC) says.

    The recalled broccoli florets were sold at Walmart stores in 20 states including Alaska, Arkansas, Arizona, California, Colorado, Idaho, Illinois, Indiana, Kentucky, Louisiana, Michigan, Montana, Nevada, Ohio, Oklahoma, Oregon, Texas, Utah, Washington, and Wyoming.

    The product has a best-by date of December 10, 2024, UPC code of 6 81131 32884 5, and lot code of BFFG327A6. While the best-by date has passed, the FDA is concerned people may have the recalled product in their freezers. If you have the broccoli florets in your kitchen, throw them away immediately.



    The Food and Drug Administration (FDA) has issued a warning about a recent recall of broccoli due to the potential risk of listeria contamination. The recall is considered a Class I recall, which means there is a reasonable probability that consuming the product could cause serious health consequences or even death.

    Listeria is a bacteria that can cause serious and sometimes fatal infections in young children, frail or elderly people, and individuals with weakened immune systems. Symptoms of listeria infection include fever, muscle aches, diarrhea, and other gastrointestinal issues.

    Consumers are urged to check their refrigerators and freezers for any recalled broccoli products and to dispose of them immediately. It is important to thoroughly clean and sanitize any surfaces that may have come into contact with the contaminated products to prevent the spread of listeria.

    The FDA is working closely with the manufacturer to investigate the source of the contamination and to prevent any further outbreaks. In the meantime, consumers are advised to avoid consuming any broccoli products that may be affected by the recall.

    Stay tuned for more updates on this developing story as more information becomes available. Stay safe and always prioritize your health and well-being.

    Tags:

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    2. Class I recall
    3. Listeria risk
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    #Broccoli #Recall #Considered #Class #Due #Deadly #Listeria #Risk #FDA #Warns

  • FDA escalates Walmart broccoli recall


    Check out what’s clicking on FoxBusiness.com.

    A recall over Walmart-sold broccoli florets has been escalated to Class I, the highest threat level, as consumers are warned to discard the food products over potential contamination.

    Braga Fresh has been recalling some packages of its ready-to-eat 12oz Marketside Broccoli Florets since Dec. 27. The FDA announced the recall on Dec. 31 and recently upgraded its classification. 

    Class I recalls, which are the most serious category of FDA food recalls, refer to “situation[s] in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

    The recall only pertains to 12oz bags of Marketside Broccoli Florets sold at Walmart stores. The recalled products have a UPC code of “6 81131 32884 5” on the back of the bag, and a best-by date of Dec 10, 2024. The products also contain a a lot code of “BFFG327A6”.

    POPULAR FROZEN MEAL SOLD AT ALDI RECALLED ACROSS 31 STATES FOR METAL CONTAMINATION: ‘DISCARD IT IMMEDIATELY’

    Braga said sales of the broccoli florets occurred at Walmart stores in 20 states. (Food and Drug Administration)

    “All potentially affected products are past their expiration date and no longer for sale,” the Braga Foods statement read. “This voluntary advisory does not apply to any other Marketside or Braga Fresh produced products.”

    “This product is past its [best-by date] and is no longer in stores, but consumers may have frozen the item for later use,” the release added. “Consumers who have this product in their freezers should not consume and discard the product.”

    According to the statement, the recall was initiated “due to possibility of contamination with Listeria monocytogenes.” 

    “The potential for contamination was discovered during random sampling by Texas Health & Human Services from a Texas store location where one of multiple samples yielded a positive test result,” the statement read.

    The Walmart locations that received the potentially affected product are located in Alaska, Arkansas, Arizona, California, Colorado, Idaho, Illinois, Indiana, Kentucky, Louisiana, Michigan, Montana, Nevada, Ohio, Oklahoma, Oregon, Texas, Utah, Washington and Wyoming.

    MORE THAN 500,000 ELECTRIC SPACE HEATERS RECALLED DUE TO OVERHEATING CONCERNS

    A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland. (Sarah Silbiger/Getty Images / Getty Images)

    Though no illnesses have been reported in connection to the products, Listeria monocytogenes can lead to listeriosis, which is especially deadly to pregnant women, older adults and people with weakened immune systems.

    “Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women,” the FDA said in a statement.

    In a statement, Walmart told FOX Business that the health and safety of its customers is “always a top priority.” 

    “While the expiration date for the potentially impacted Marketside Broccoli Florets has past and the product is no longer in stores, we encourage customers who may still have this product in their homes, such as stored in freezers, to not consume and to discard the product,” the spokesperson explained. “At this time, there have been no reported illnesses associated with this advisory, and we are working with the supplier to investigate.”

    CLICK HERE TO READ MORE ON FOX BUSINESS

    A Walmart store in Secaucus, New Jersey, US, on Friday, Nov. 24, 2023. (Victor J. Blue/Bloomberg via Getty Images / Getty Images)

    FOX Business reached out to Braga Foods for comment.

    FOX Business’ Aislinn Murphy contributed to this report.



    The Food and Drug Administration (FDA) has escalated the recall of broccoli products sold at Walmart due to potential listeria contamination. The recall now includes all broccoli products sold at Walmart stores nationwide, urging consumers to check their refrigerators and freezers for any affected items.

    Listeria is a dangerous bacteria that can cause serious and sometimes fatal infections, especially in young children, elderly individuals, and those with weakened immune systems. Symptoms of listeria infection include fever, muscle aches, and gastrointestinal issues.

    Consumers who have purchased any broccoli products from Walmart are advised to immediately discard them or return them to the store for a refund. The FDA is working closely with Walmart to investigate the source of the contamination and prevent any further cases of illness.

    It is important to always follow food safety guidelines and properly store and handle produce to prevent the spread of harmful bacteria. Stay informed about product recalls and take action to protect yourself and your family from potential health risks.

    Tags:

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    2. Walmart broccoli
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    #FDA #escalates #Walmart #broccoli #recall

  • FDA elevates risk, what to know




    The Food and Drug Administration (FDA) has recently elevated the risk level on certain medications and products. It is important to stay informed and educated on these changes to ensure your safety and well-being.

    Here are some key things to know about the FDA’s recent risk elevation:

    1. Pay attention to any warnings or recalls issued by the FDA. If a product you are using has been deemed unsafe or high-risk, it is important to discontinue use immediately.

    2. Consult with your healthcare provider if you have any concerns about the medications or products you are using. They can provide guidance on alternative options or potential risks.

    3. Stay informed by regularly checking the FDA’s website or other reputable sources for updates on risk assessments and safety alerts.

    4. Be cautious when trying new medications or products, and always follow the recommended dosage and usage instructions.

    5. Report any adverse reactions or side effects to the FDA through their MedWatch program. Your feedback can help prevent harm to others and prompt further investigations.

    By staying vigilant and proactive, you can protect yourself from potential risks associated with FDA-elevated products. Stay informed, stay safe!

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  • Recalled broccoli sold at Walmart labeled potentially deadly by FDA amid listeria concerns


    The U.S. Food and Drug Administration has updated a previous voluntary recall of ready-to-eat broccoli florets sold across 20 states due to listeria concerns to reflect the agency’s highest classification.

    Braga Fresh Foods initially issued a voluntary recall for one lot of its 12-ounce bags of Marketside Broccoli Florets on Dec. 27, 2024, according to the original company announcement shared by the FDA on Dec. 31, 2024.

    In an updated report posted Jan. 27, 2025, the FDA classified the recall under its “Class I” designation, the agency’s top risk level, which indicates a “reasonable probability” that “use of, or exposure to” the product in question “will cause serious adverse health consequences or death.”

    The California-based food manufacturer said in its Dec. 27 recall notice that the “potential for contamination was discovered during random sampling by Texas Health & Human Services from a Texas store location where one of multiple samples yielded a positive test result.”

    The company noted at the time that no illnesses had been reported in connection to the recalled food.

    The recalled bags of Marketside Broccoli Florets were sold at Walmart stores in 20 states, according to the original recall notice.

    Braga Fresh issued a voluntary recall of washed and ready-to-eat 12oz Marketside Broccoli Florets sold at some Walmart stores.

    FDA

    The bags feature a “best if used by” date of Dec. 10, 2024, and have a UPC code of 6 81131 32884 5 on the back and a lot code of BFFG327A6.

    Braga Fresh Foods noted in December that the recalled bags were no longer for sale at that time and were past their expiration date.

    If consumers are in possession of a recalled bag, they are urged to discard the bag and not to consume the product, according to the original recall notice.

    States where recalled broccoli was sold

    According to the FDA, recalled broccoli was sold at Walmart stores in the below states:

    Alaska
    Arkansas
    Arizona
    California
    Colorado
    Idaho
    Illinois
    Indiana
    Kentucky
    Louisiana
    Michigan
    Montana
    Nevada
    Ohio
    Oklahoma
    Oregon
    Texas
    Utah
    Washington
    Wyoming

    What to know about listeria and its symptoms

    Listeria monocytogenes is a bacteria that, when ingested, can cause an infection known as listeriosis, according to the U.S. Centers for Disease Control and Prevention.

    The condition is most dangerous for pregnant people, newborns, people with weakened immune systems and adults 65 or older, according to the CDC.

    For people who are pregnant, being infected by listeria can cause pregnancy loss or premature birth, the CDC notes.

    According to the CDC, an estimated 1,600 people get listeriosis annually in the U.S. and about 260 people die from it.

    The best way to avoid listeria, according to the CDC, is to avoid contaminated foods when possible and other high-risk foods such as unpasteurized dairy products, soft cheeses, raw or undercooked meats, and ready-to-eat deli meats unless they are reheated until steaming hot.

    People who may have been exposed to listeria can watch for symptoms anywhere from 24 hours to two weeks after eating contaminated food.

    Listeria can cause an intestinal illness that develops typically within 24 hours of eating contaminated food and usually lasts one to three days.

    Symptoms of intestinal listeriosis are typically mild and include diarrhea and vomiting, according to the CDC.

    A more severe type of listeriosis, known as invasive listeriosis, occurs when listeria spreads beyond the intestines, according to the CDC.

    Symptoms of invasive listeriosis typically start within two weeks after eating contaminated food, according to the CDC, and include a fever and flu-like symptoms including fatigue and muscle aches as well as headaches, confusion and loss of balance.

    The CDC recommends seeing a health care provider if you ate a food that has been recalled or linked to a listeria outbreak, and you experience symptoms of listeriosis such as a fever, fatigue and muscle aches.

    An earlier version of this story was published on Jan. 2, 2025.



    Attention Walmart shoppers: the Food and Drug Administration (FDA) has issued a warning about recalled broccoli sold at Walmart that may be potentially deadly due to listeria concerns.

    The recalled broccoli, which was sold under various brand names at Walmart stores, has been found to be contaminated with listeria, a harmful bacteria that can cause serious illness and even death in certain individuals.

    If you have purchased any broccoli from Walmart recently, please check the packaging for any of the following brand names: [list of brand names]. If you find that you have purchased recalled broccoli, do not consume it and return it to Walmart for a full refund.

    It is important to take this warning seriously, as listeria can be especially dangerous for pregnant women, young children, the elderly, and individuals with weakened immune systems. If you have consumed the recalled broccoli and are experiencing symptoms such as fever, muscle aches, nausea, or diarrhea, please seek medical attention immediately.

    Your health and safety are our top priority, and we apologize for any inconvenience this may cause. Thank you for your attention to this important matter.

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  • FDA upgrades recall of Lay’s potato chips to most serious level : NPR


    The FDA has upgraded a recall of over 6,000 bags of Frito-Lay Lay’s Classic Potato Chips to a Class I recall, the agency's highest level of severity

    The FDA has upgraded a recall of over 6,000 bags of Frito-Lay Lay’s Classic Potato Chips to a Class I recall, the agency’s highest level of severity.

    Justin Sullivan/Getty Images


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    Justin Sullivan/Getty Images

    An FDA recall on Lay’s potato chips originally issued in December has been upgraded by the agency to its highest risk level.

    Three things to know

    1. The original recall was issued mid-December, with more than 6,000 bags of Lay’s 13 oz. bags of classic chips removed from shelves in Washington and Oregon.
    2. The problem ingredient identified was “undeclared milk” which poses a risk to those with severe sensitivities or allergies.
    3. On Jan. 27th, the FDA upgraded the recall to “Class I,” their most severe, meaning that, “the use of, or exposure to, a violative product will cause serious adverse health consequences or death,” according to their website.

    Want the latest stories on the science of healthy living? Subscribe to the Health newsletter.

    What other recalls have happened recently?

    It appears that eggs can’t stay out of the headlines as a recall on Kirkland Brand eggs, sold at Costco, received the same designation in late December after the FDA first issued a voluntary recall in November.

    The recall covered 10,800 packages of 24-count eggs, sold under the Kirkland Signature brand name and described as organic and pasture-raised.

    Dive deeper with NPR

    • No, it’s not just you; food recalls have been increasing lately. Read here to find out why.
    • From A to Zika, get the latest global health and development news, sent weekly to your inbox, with the Goats and Soda newsletter.



    FDA Upgrades Recall of Lay’s Potato Chips to Most Serious Level: NPR

    In a recent development, the Food and Drug Administration has upgraded the recall of Lay’s potato chips to the most serious level. This decision comes after reports of potential contamination with harmful bacteria that could pose a serious health risk to consumers.

    According to NPR, the FDA has issued a warning to consumers to immediately stop consuming Lay’s potato chips and to return any affected products to the store for a full refund. The agency is working closely with the manufacturer to investigate the source of the contamination and ensure that all potentially affected products are removed from shelves.

    This news is concerning for potato chip lovers across the country, as Lay’s is a popular and widely consumed brand. The FDA is urging consumers to check their pantry for any bags of Lay’s potato chips and to dispose of them if they are part of the recall.

    Stay tuned for further updates on this developing story as the FDA continues to investigate the situation. In the meantime, it is important to prioritize food safety and follow the FDA’s guidance to protect yourself and your family from potential harm.

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    #FDA #upgrades #recall #Lays #potato #chips #level #NPR

  • FDA gives some products highest risk level


    A California snack company recalled chocolate and other products last month. Now, the U.S. Food & Drug Administration has given some of those products a Class I classification which is the agency’s highest risk level.

    The products were recalled due to undeclared milk, soy, wheat, sesame, synthetic dye, and almonds that could lead to allergic reactions, according to an announcement the company shared through the FDA.

    While no illnesses have been reported, the manufacturer, Cal Yee Farm LLC of Suisun Valley, California, is recalling chocolate and yogurt-covered products such as Dark Chocolate Walnuts, Dark Chocolate Raisins, Dark Chocolate Almonds, and more.

    “People who have an allergy or severe sensitivity to milk, soy, wheat, sesame, FD&C #6 (synthetic dye), and almonds run the risk of serious or life-threatening allergic reaction if they consume these products,” the company said.



    The Food and Drug Administration (FDA) has recently classified certain products as having the highest risk level, indicating potential dangers to consumers. These products include certain medical devices, prescription drugs, and food items that pose serious health risks if not used properly.

    This classification serves as a warning to consumers to exercise caution when using these products and to follow all instructions and warnings provided by the manufacturer. The FDA is working to ensure that these products are properly regulated and that measures are in place to protect the public from potential harm.

    It is important for consumers to be aware of these high-risk products and to report any adverse effects or concerns to the FDA. By staying informed and taking necessary precautions, we can help to prevent unnecessary harm and ensure the safety of all consumers.

    Tags:

    FDA, highest risk level, FDA regulations, product safety, FDA approval, health risks, product classification, FDA guidelines, product labeling, product testing, consumer safety, FDA compliance, product recalls, product liability, product safety standards

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  • FDA approves Vertex non-opioid painkiller drug Journavx


    A sign hangs in front of the world headquarters of Vertex Pharmaceuticals in Boston.

    Brian Snyder | Reuters

    The Food and Drug Administration on Thursday approved Vertex Pharmaceuticals‘ non-opioid painkiller pill, a new alternative for pain relief that comes without the risk of addiction. 

    Vertex is now the first drugmaker in decades to gain U.S. approval for a new type of pain medicine. It’s a milestone after a long history of mostly unsuccessful efforts to develop painkillers without the destructive dependency of cheap and widely available opioids, which have caused a horrific epidemic of abuse and overdose in the U.S.

    Vertex’s drug, Journavx, is specifically approved for the treatment of moderate-to-severe acute pain, which is usually caused by injury, surgery, illness, trauma or painful medical procedures and likely eases with time. Around 80 million patients are prescribed a medicine for their moderate-to-severe acute pain every year in the U.S., according to Vertex. 

    Wall Street analysts have said that the medication could become a blockbuster drug if it wins approval from regulators, estimating its annual sales could exceed $1 billion. 

    The experience of pain starts in a nerve ending, and the body detects the pressure and sends a signal to the spinal cord and then the brain. Vertex’s treatment works by blocking pain signals at their origin before they reach the brain. That’s different from opioids, which act directly on the brain to block pain, triggering the brain’s rewards centers in a way that can feed addiction.

    The approval underscores the “FDA’s commitment to approving safe and effective alternatives to opioids for pain management,” said Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, in a release.

    Vertex’s painkiller was more effective than placebo at reducing the intensity of pain after 48 hours in two late-stage studies on more than 1,000 patients who had abdominoplasties, also known as “tummy tucks,” and roughly another thousand in people who had bunion surgery. Those two procedures are commonly used in studies of people with acute pain.

    The painkiller, however, failed to meet the secondary goal in both trials of reducing pain when compared to a combination of the opioid drug hydrocodone, which is frequently abused, and acetaminophen, the basis for popular pain medications such as Tylenol.

    In both trials, rates of adverse side effects were lower in those who received Vertex’s drug compared to people who took a placebo. The most commonly reported adverse events among people who received Journavx were itching, muscle spasms and rash, among others, according to the FDA.

    In a separate phase three study, more than 83% of patients said in a survey that the drug was good, very good or excellent at easing pain. Those people had undergone various surgical or non-surgical procedures.

    The bigger opportunity for Vertex may be to win FDA approval in chronic pain. That’s an area where the risk of addiction to prescription opioids can be greater, according to the Centers for Disease Control and Prevention. 

    In 2023, the company’s painkiller produced positive results in a mid-stage trial in diabetes patients suffering from a chronic nerve condition.



    The FDA has just approved a groundbreaking new non-opioid painkiller drug called Journavx, developed by Vertex Pharmaceuticals. This is a major milestone in the fight against the opioid epidemic, as Journavx offers a much-needed alternative for pain management without the risk of addiction or overdose.

    Journavx works by targeting specific receptors in the brain that are involved in the perception of pain, providing effective relief without the side effects commonly associated with traditional opioid medications. Clinical trials have shown promising results, with patients reporting significant reductions in pain levels and improved quality of life.

    The approval of Journavx represents a significant step forward in the development of safer and more effective pain management options. This new drug has the potential to revolutionize the way we treat pain, offering hope for millions of patients who struggle with chronic pain on a daily basis.

    Vertex Pharmaceuticals is committed to bringing innovative solutions to market, and Journavx is a prime example of their dedication to improving patient care. With the FDA’s stamp of approval, this new non-opioid painkiller is set to make a positive impact on the lives of countless individuals.

    Tags:

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    2. Vertex Pharmaceuticals
    3. Non-opioid
    4. Painkiller
    5. Drug approval
    6. Journavx
    7. Pain management
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    #FDA #approves #Vertex #nonopioid #painkiller #drug #Journavx

  • FDA approves first new type of pain medication in 25 years




    CNN
     — 

    The US Food and Drug Administration signed off Thursday on the first new type of pain reliever to be approved in more than two decades.

    The drug, suzetrigine, is a 50-milligram prescription pill that’s taken every 12 hours after a larger starter dose. It will be sold under the brand name Journavx.

    “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option,” Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, said in a news release. “This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”

    Government surveys show that analgesics, or medications that control pain, are the most commonly prescribed type of drug in hospitals.

    About 80 million Americans fill prescriptions each year for medications to treat new instances of moderate to severe pain, according to a study by Vertex Pharmaceuticals, the company that developed the new drug; about half those prescriptions are written for opioid medications, which can lead to dependence and addiction.

    Suzetrigine is the first new painkiller approved in the US since Celebrex, a type of nonsteroidal anti-inflammatory drug called a Cox-2 inhibitor, which was approved in 1998.

    Multiple parts of the body are involved in the sensation of pain, explains Dr. Sergio Bergese, an anesthesiologist at Stony Brook University’s Renaissance School of Medicine. Nerve cells carry an electrical signal from the site of tissue damage up to the brain, which perceives the signal as pain.

    Unlike opioid medications, which dull the sensation of pain in the brain, suzetrigine works by preventing pain-signaling nerves around the body from firing in the first place.

    “This drug, what it is doing is interrupting that path, so even though the tissue injury exists, the brain doesn’t know,” Bergese said.

    And crucially, suzetrigine creates no euphoria or high like opioids sometimes can, so doctors believe there’s no potential for it to create addition or dependence in people who use it.

    The medication was discovered after researchers learned about a family of fire walkers in Pakistan and discovered that they lacked a gene allowing pain signals fire in their skin. Members of this family could walk over hot coals without flinching.

    “They knew that they were on something hot; they knew they could feel the coals. So it’s not impacting the nerves that do heat and touch and stuff like that. It is just these pain-conducting nerves,” said Stuart Arbuckle, chief operating officer of Vertex Pharmaceuticals. “They were, in every other way, normal.”

    Still, it took scientists 25 years to figure out how to exploit that pain-conducting mechanism to develop a medication.

    “Neurons talk to each other by producing series of nerve impulses, like a Morse code,” said Dr. Stephen Waxman, who directs the Center for Neuroscience and Regeneration Research at the Yale School of Medicine. “And nerve impulses are produced by tiny molecular batteries within the membranes of neurons. The molecular batteries are called sodium channels.”

    Suzetrigine works by closing one sodium channel that conducts only pain signals.

    There have been many false starts along the way to finding a drug that could block one specific sodium channel. Suzetrigine’s approval means other drugs that could work even better are likely to follow, Waxman said.

    “It is an important step forward, because it provides proof of concept that a [sodium-channel blocker] can reduce pain in humans,” said Waxman, who has no financial ties to the new drug. “That opens up the door to a second generation of even more effective [medications].”

    Suzetrigine is a pill that’s given in two dosages. In studies, participants got an initial dose of 100 milligrams, followed by 50 milligrams every 12 hours.

    Doctors stress that it may not be the right drug for everyone or for every type of pain.

    In two clinical trials that included almost 600 participants, suzetrigine controlled pain after abdominal and foot surgeries better than an inactive placebo pill. About as many people said suzetrigine reduced their pain by at least half after surgery as those who took Vicodin, which is a combination of acetaminophen and the opioid hydrocodone. The research wasn’t designed to directly compare suzetrigine to Vicodin, however, so it’s hard to know whether one worked better than the other.

    On a well-known rating scale that runs from 0 to 10, the study participants started with pain of about seven, on average, and suzetrigine reduced it roughly 3.5 points.

    “It’s not like eliminating all pain,” Arbuckle said. “It’s reducing pain by about 50%.”

    In a third study, of people who had back pain caused by sciatica, suzetrigine reduced pain by about 2 points, the same amount reported by people taking a placebo, suggesting that this drug might not be a standout for chronic pain.

    Vertex disagrees, saying that it has tested the drug in different types of chronic pain and that it seems to work for long-term pain, too. The company is continuing to test it in people who have diabetic neuropathy, in which high blood sugar levels damage nerves over time, leading to symptoms such as numbness, tingling, pain and muscle weakness.

    The sciatica study was smaller than the others, with about 100 people in the suzetrigine arm and in the placebo group, so there may not have been enough participants to show clear differences between the groups. Placebos tend to have large effects in pain studies too, which complicates their interpretation.

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    “In our opinion, the drug did what we expected to do in terms of the amount of pain relief,” Arbuckle said. “But unfortunately, as often happens in studies in pain, there is quite a large placebo response.”

    Doctors who help people manage pain said they were excited to have a new option.

    “The more options we have, the better we’re able to treat each and every patient,” said Dr. Kimberley Mauer, an anesthesiologist at Oregon Health and Science University.

    Mauer said cost might be a big factor in how the drug is used. Vertex said that it has set a wholesale cost of $15.50 per 50-mg pill but that patient assistance programs would be available.

    Mauer said doctors and patients would have to wait to learn what insurance companies might do in terms of coverage.

    “It might limit some patients getting it. So we just have to kind of see, and it’s hard to tell until it kind of gets out on the market,” she said.



    Exciting News: FDA Approves First New Type of Pain Medication in 25 Years!

    In a groundbreaking decision, the Food and Drug Administration (FDA) has approved a new type of pain medication for the first time in a quarter of a century. This innovative drug offers hope for millions of individuals suffering from chronic pain, providing a much-needed alternative to traditional pain management options.

    The approval of this new medication marks a significant milestone in the field of pain management, as researchers have been working tirelessly to develop new and more effective treatments for those in need. With the opioid epidemic still looming large, the introduction of this non-opioid pain medication is a much-welcomed development.

    While the specifics of the new medication have not been disclosed, its approval signals a new era in pain relief and a step forward in addressing the diverse needs of patients. This groundbreaking achievement will undoubtedly pave the way for further advancements in pain management and improve the quality of life for countless individuals.

    Stay tuned for more updates on this exciting development and the potential impact it may have on the field of pain management. The approval of this new type of pain medication is a promising step towards a safer and more effective future for those struggling with chronic pain.

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    8. FDA regulations
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    10. pain medication development

    #FDA #approves #type #pain #medication #years

  • FDA Recalls Lay’s Potato Chips—Here’s What You Need To Know


    The list of recalled food products being elevated to Class I (the highest recall level) by the U.S. Food and Drug Administration (FDA) is continuing to grow. This time, the organization has updated its Lay’s Classic Potato Chips recall to Class I. The potato chips were previously recalled last December due to an undeclared milk allergen.

    “Frito-Lay today issued a recall of a limited number of 13 oz. bags of Lay’s Classic Potato Chips that may contain undeclared milk, after being alerted through a consumer contact. Those with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the recalled product,” read an announcement made by the FDA on December 16.

    The affected bags of chips, which are no longer on store shelves, were distributed to certain retail stores and e-commerce distributors in Oregon and Washington. They have a “Guaranteed Fresh” date of Feb. 11, 2025 and one of the two following manufacturing codes: 6462307xx or 6463307xx.

    In the initial recall, consumers who have an allergy or sensitivity to milk were informed not to consume the product and discard it immediately.

    Several other products have been elevated to Class I from the FDA this month. Those products include Costco’s Kirkland Signature Smoked Salmon and Walmart’s Marketside Broccoli Florets.

    Class I is the highest risk level assigned by the FDA and one that means there’s a very serious risk of death. According to the organization’s website, Class I is described as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

    Lettermark

    Danielle Harling is an Atlanta-based freelance writer with a love for colorfully designed-spaces, craft cocktails and online window shopping (usually for budget-shattering designer heels). Her past work has appeared on Fodor’s, Forbes, MyDomaine, Architectural Digest and more. 



    The Food and Drug Administration (FDA) has issued a recall for certain varieties of Lay’s potato chips due to potential contamination. Here’s what you need to know:

    The affected products include Lay’s Lightly Salted Barbecue Flavored Potato Chips in 7 3/4 oz. bags with a “Guaranteed Fresh” date of August 27, 2021. The recall was initiated after a routine inspection found that these chips may contain an undeclared allergen (milk) not listed on the packaging.

    Consumers who have purchased these Lay’s potato chips are advised to check the expiration date on the packaging and to not consume the product if it matches the specified date. Instead, they should return the product to the place of purchase for a full refund.

    There have been no reported illnesses or adverse reactions related to this recall, but it is always better to err on the side of caution when it comes to potential allergen exposure.

    For more information on the Lay’s potato chip recall, consumers can visit the FDA’s website or contact Lay’s customer service at 1-800-352-4477.

    Stay informed and stay safe!

    Tags:

    FDA recalls, Lay’s Potato Chips, potato chip recall, food safety, FDA news, food recall, product recall, snack recall, potato chip safety, Lay’s chips, consumer alert, food warning

    #FDA #Recalls #Lays #Potato #ChipsHeres

  • FDA issues Class 1 recall for salmon sold at popular retail chain


    CINCINNATI (WKRC) – An FDA recall of smoked salmon from a popular chain of retail stores was recently reclassified as a Class 1 recall, the highest risk level available.

    The Food and Drug Administration issued a recall for Kirkland Signature brand smoked salmon, sold at Costco, for possible Listeria Monocytogenes contamination in October of 2024, but the recall was recently readjusted to Class 1, the highest risk level, which the FDA defines on its website as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

    The recall specifically affects 111 cases of Kirkland Signature Smoked Salmon in twin 12 ounce packages, UPC 0 96619 25697 6, Lot 8512801270 with the best by date of 11/13/2024.

    The product had not been on shelves for some time, but it is possible that some customers still have it in their freezer for later use.

    Those who purchased the product should throw it away or return it to Costco for a refund.

    More information can be found on the FDA’s website.



    The Food and Drug Administration (FDA) has issued a Class 1 recall for salmon sold at a popular retail chain due to potential health risks.

    Customers who have purchased salmon from this retail chain are advised to check the packaging for specific lot numbers and expiration dates provided by the FDA. The recall was issued after routine testing found potential contamination that could lead to serious illness if consumed.

    It is important for consumers to check their refrigerators and freezers for any salmon that matches the recalled products and to immediately return them to the store for a full refund.

    The FDA urges anyone who has consumed the recalled salmon and is experiencing symptoms such as nausea, vomiting, diarrhea, or fever to seek medical attention immediately.

    Stay informed and stay safe by following updates from the FDA and the retail chain regarding this salmon recall. Your health is of utmost importance.

    Tags:

    • FDA Class 1 recall
    • Salmon recall
    • Retail chain recall
    • Food and Drug Administration recall
    • FDA salmon recall
    • Popular retail chain salmon recall
    • Food safety recall
    • Salmon product recall
    • FDA Class 1 recall alert
    • Retail chain salmon product recall

    #FDA #issues #Class #recall #salmon #sold #popular #retail #chain

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