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Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications like Vicodin and OxyContin.The U.S. Food and Drug Administration said it approved Vertex Pharmaceuticals’ Journavx for short-term pain that often follows surgery or injuries.It’s the first new pharmaceutical approach to treating pain in more than 20 years, offering an alternative to both opioids and over-the-counter medications like ibuprofen and acetaminophen. But the medication’s modest effectiveness and lengthy development process underscore the challenges of finding new ways to manage pain.Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertex’s drug provided more relief than a dummy pill but didn’t outperform a common opioid-acetaminophen combination pill.“It’s not a slam dunk on effectiveness,” said Michael Schuh of the Mayo Clinic, a pharmacist and pain medicine expert who was not involved in the research. “But it is a slam dunk in that it’s a very different pathway and mechanism of action. So, I think that shows a lot promise.”The new drug will carry a list price of $15.50 per pill, making it many times more expensive than comparable opioids, which are often available as generics for $1 or less.Vertex began researching the drug in the 2000s, when overdoses were rocketing upward, principally driven by mass prescribing of opioid painkillers for common ailments like arthritis and back pain. Prescriptions have fallen sharply in the past decade and the current wave of the opioid epidemic is mainly due to illicit fentanyl, not pharmaceutical medicines.Opioids reduce pain by binding to receptors in the brain that receive nerve signals from different parts of the body. Those chemical interactions also give rise to opioids’ addictive effects.Vertex’s drug works differently, blocking proteins that trigger pain signals that are later sent to the brain.“In trying to develop medicines that don’t have the addictive risks of opioid medicines, a key factor is working to block pain signaling before it gets to the brain,” Vertex’s Dr. David Altshuler, told the Associated Press last year.Commonly reported side effects with the drug were nausea, constipation, itching, rash, and headache.“The new medication has side effect profiles that are inherently, not only different, but don’t involve the risk of substance abuse and other key side effects associated with opioids,” said Dr. Charles Argoff of the Albany Medical Center, who consulted for Vertex on the drug’s development.The initial concept to focus on pain-signaling proteins came out of research involving people with a rare hereditary condition that causes insensitivity to pain.Vertex has attracted interest from Wall Street for its ambitious drug pipeline that involves winning FDA approval for multiple drugs across several forms of chronic pain, which generally represents a bigger financial opportunity than acute pain.But the Boston drugmaker’s share price plummeted in December when Vertex reported disappointing mid-stage results in a study of patients with chronic nerve pain affecting the lower back and legs. The drug didn’t perform significantly better than placebo, the research found.“We believe the data reflect a near worst-case scenario for this key pipeline program,” biotechnology analyst Brian Abrahams said in a research note to investors, adding that the results jeopardized estimates that Vertex’s pipeline could be worth billions across multiple forms of pain.Still, Vertex executives said they plan to move forward with a new, late-stage study of the drug, theorizing that a different trial design could yield better results and pave the way for FDA approval in chronic pain. AP video journalist Mary Conlon contributed to this story from New York. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. Matthew Perrone, AP Health Writer
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If you enjoy snacking on chocolate-covered pretzels, you’ll want to make sure you dont have a specific variety of the tasty snacks from Fresh Direct in your possession. Thats because the chocolate-covered pretzels in question contain an undeclared milk allergen that could cause life-threatening health consequences in some people, up to and including death. Heres what you need to know about the recall. Whats happened? Food distributor United Natural Trading LLC of Edison, New Jersey, has announced a recall of one of its Fresh Direct Dark Chocolate Covered Pretzels products after it was found to contain an undeclared milk allergen. As a result, the company decided to issue a voluntary recall. What product is being recalled? The voluntary recall only includes one product, according to the recall notice posted on the website of the Food And Drug Administration (FDA). The details of the product involved in the recall, which has an undeclared milk allergen, are as follows: Description: Fresh Direct Dark Chocolate Covered Pretzels Lot Number: 24353 Best By Date: 06/30/2025 UPC#: 811102026276 Images of the product can be found here. Where was the recalled product sold? According to the notice on the FDAs website, the above product was sold online via a third-party vendor site. The products were shipped to Connecticut, New Jersey, and New York. What is a milk allergen? A food allergen is a type of food that causes an adverse reaction in the person who consumes it. According to the FDA, there are nine major food allergens. The first one the FDA lists is the milk allergen, which is the reason for this recall. Milk allergens can cause a number of uncomfortable reactions in the body as well as lead to an acute reaction called anaphylaxis, which can be deadly. What are the symptoms of a milk allergy? Milk allergy symptoms are wide-ranging and can differ based on the individual, according to the Mayo Clinic. Symptoms can present within a few minutes to a few hours of consuming the milk product. Immediate symptoms usually include: Hives Wheezing Itching or tingling feeling around the lips or mouth Swelling of the lips, tongue, or throat Coughing or shortness of breath Vomiting The Mayo Clinic says the following symptoms may take more time to appear: Loose stools or diarrhea, which may contain blood Abdominal cramps Runny nose Watery eyes Colic, in babies However, the greatest threat from a milk allergen comes from its ability to cause anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that can lead to the person being unable to breathe. Anaphylaxis is a medical emergency that requires immediate treatment as it can lead to death. The Mayo Clinic says signs of anaphylaxis include: Constriction of airways, including a swollen throat that makes it difficult to breathe Facial flushing Itching Shock, with a marked drop in blood pressure What do I do if I have the recalled Fresh Direct pretzels? Do not consume them. Instead, dispose of them. According to the FDA notice, consumers can also retain the packaging for the recalled pretzels and its online receipt or other proof of purchase so they may receive a refund. Consumers can contact United Natural Trading LLC for more information at 732-650-9905 between 9 a.m. and 5 p.m. EST, Monday to Friday.
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Worried about getting canceled? Theres now insurance policy for that. Insurance agency Samphire Risk is rolling out cancel culture insurance for celebrities and execs afraid of social media backlash, according to a report from the Financial Times. London-based Samphire already insures high-value clients against extortion, kidnap, hostage-crises, terrorism and travel to dangerous countries. Now, it’s adding cancellation to the list. The policy, called Preempt and also available to businesses, gives crisis management communications services designed to help the canceled minimize the damage done. For 60 days, a team will go to battle against any negative press across social media and traditional media. Theres also a 24/7 hotline, perfect for when you fire off a rogue tweet at 2 a.m. and need emergency damage control. Additionally, the policy provides a team of researchers and analysts who will help flag potential reputational risks before they blow up in your face. Sharing or liking a tweet can bring the whole world down on you, Mark Borkowski, a veteran PR boss who designed the policy alongside risk partner RepuTitan, told the FT. There are a lot of anxious people. The cancel button is the new guillotine [and] one mistake is your epitaph. Its too easy to take a position on things ... without being thoughtful. What’s your good reputation worth? The policy isnt just about PR crises; it also covers modern digital threats like misinformation, deepfakes, extortion, blackmail, and even family-related risks. Borkowski said the policy was not designed for people who had broken the law or who were guilty of wrongdoing, but for those worried that their words could be twisted or taken out of context. Premiums are calculated based on wealth, annual earnings, and a deep dive into a clients past behavior and social media activity. In other words, the more controversial your digital footprint, the higher the price tag. In the age of cancel culture, the appeal is understandable. Just days ago, Selena Gomez deleted a tearful video about President Trumps ICE deportations after being hit with social media backlash. Meanwhile, Justin Baldoni is currently is currently fighting for his reputation online over Blake Livelys It Ends With Us lawsuit and damning allegations about his on-set behavior. At the same time, the pendulum seems to be swinging back to a time where online, anything goes. Elon Musk has turned X into a megaphone for his far-right politics, while Meta is currently undoing content moderation across Facebook and Instagram. For those who remain cautious, the chance at some extra protection against keyboard warriors may seem like a savvy investment. Orsome free adviceif you have nothing nice to say, just dont say anything.
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