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FDA approves opioid-free pain medication with 'no sign of addiction'

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FDA approves opioid-free pain medication with 'no sign of addiction'

A new opioid-free pain medication was approved by the U.S. Food and Drug Administration (FDA) on Thursday, marking a non-addictive alternative for patients.

Journavx (suzetrigine), made by Vertex, is the “first and only approved non-opioid oral pain signal inhibitor,” according to a press release from the Massachusetts-based company.

The new drug is intended for treatment of moderate to severe acute pain in adults. 

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Importance of a non-opioid alternative

Patients with acute pain after surgery or due to a broken bone or an injury are often prescribed opioid medications, according to Julie Pilitsis, MD, PhD, a neurosurgeon at Banner – University Medicine and chair of the Department of Neurosurgery at the University of Arizona College of Medicine in Tucson.

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A new opioid-free pain medication was approved by the FDA on Thursday, marking a non-addictive alternative for patients. (iStock)

“This is the first time many patients receive opioids, and a subset of patients are known to go on to become dependent or addicted to the medications,” she told Fox News Digital.

“Patients with pain have had very few options to treat their pain with medications that don’t have addictive properties or side effects they can’t tolerate.”

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The main reason traditional pain relievers have addictive properties or intolerable side effects is that they work by modifying receptors in the brain, Pilitsis noted.

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“This medication — which is a drug that inhibits sodium channels — works outside the brain on pain receptors,” she noted.

“To have a non-opioid option to prescribe in these cases is exciting — and this is the first time in nearly two decades that we have something new to offer patients for acute pain.”

‘Major unmet need’

Acute pain — sudden or urgent pain that results from injury, trauma or surgery — affects more than 80 million Americans annually and is the most common reason for emergency department visits, according to statistics.

Around half of these will be prescribed an opioid, and 10% of those will have “prolonged opioid use.”

Acute pain — sudden or urgent pain that results from injury, trauma or surgery — affects more than 80 million Americans annually and is the most common reason for emergency department visits. (iStock)

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In 2023, more than five million Americans 12 and older reported a “prescription use disorder” within the past year, according to the Centers for Disease Control and Prevention (CDC).

Approximately 294,000 people died from prescription opioid overdoses between 1999 and 2022, the above source stated.

By managing acute pain effectively, suzetrigine may help prevent it from developing into chronic pain without the danger of dependency, meeting a “major unmet need,” noted Jianguo Cheng, MD, PhD, a pain management specialist at Cleveland Clinic.

“This is the first time in nearly two decades that we have something new to offer patients for acute pain.”

“Many current therapies rely on opioids, contributing to dependency and misuse,” he told Fox News Digital. “Suzetrigine’s non-opioid mechanism eliminates risks of misuse, addiction and respiratory depression, making it a safer alternative for acute pain management.”

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In addition to acute pain, suzetrigine may also be a solution for neuropathic (nerve) pain, depending on the results of further studies, the doctor added.

In addition to acute pain, suzetrigine may also be a solution for neuropathic (nerve) pain, depending on the results of further studies, a doctor noted. (iStock)

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Health and Fox News senior medical analyst, also applauded the approval of suzetrigine.

      

“It has no sign of addiction, which makes it a hugely important new tool as we fight the opioid epidemic,” he told Fox News Digital.

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In clinical trials, the non-opioid medication received high patient satisfaction ratings, with 83% reporting “good” to “excellent” pain relief in real-world applications, Cheng noted.

“This drug is a big step forward and has been well-studied.”

Siegel noted that the drug has shown to decrease pain by about half, which he described as “excellent.”

“This drug is a big step forward and has been well-studied,” he added.

Access and side effects

Suzetrigine has become available for patients with acute pain, noted Pilitsis. 

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“It will be important to find physicians who are comfortable prescribing pain medications and to check with your insurance company to ensure that it is covered,” she advised.

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The medication is expected to fall under the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, effective January 2025, which provides Medicare coverage for FDA-approved non-opioid pain therapies, according to Cheng. 

“This policy aims to improve access and affordability, ensuring suzetrigine’s inclusion in outpatient and surgical settings while reducing reliance on opioids,” he said. 

In 2023, more than five million Americans 12 and older reported a “prescription use disorder” within the past year, per the CDC. (iStock)

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The most common side effects of Journavx, according to the company’s website, include itching, muscle spasms, rash, and increased levels of an enzyme called creatine phosphokinase in the blood, among others.

The drug may also cause temporary fertility challenges.

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Certain medications can increase the risk of side effects and affect the drug’s effectiveness, the company cautioned, as can food or drink containing grapefruit.

Patients should see their doctor if any side effects become bothersome or do not go away.

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Fox News Digital reached out to Vertex for additional comment.

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The Latest on Natural Ozempic Alternatives: How To Lose Weight Without GLP-1s

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The Latest on Natural Ozempic Alternatives: How To Lose Weight Without GLP-1s


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Punch the monkey, viral star, experiences dramatic breakthrough among zoo mates

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Punch the monkey, viral star, experiences dramatic breakthrough among zoo mates

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In a dramatic turn of events that’s captured the attention of animal lovers worldwide, Punch — the young macaque at a zoo in Japan famous for his inseparable bond with a stuffed orangutan toy — has reached a major milestone in his journey toward social integration.

On Thursday, visitors and staff at the Ichikawa Zoological and Botanical Garden witnessed a breakthrough: Punch was seen cuddling with and hitching a ride on the back of a fellow macaque.

Punch’s story began with hardship. He was abandoned by his mother shortly after his birth in July 2025 — and to ensure his survival, zookeepers stepped in to hand-rear the primate.

On Jan. 19, 2026, the zoo officially began the process of reintegrating Punch into the “monkey mountain” enclosure.

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The transition was initially fraught with tension. 

Punch’s story began with hardship when he was abandoned by his mother shortly after he was born. To help him, zookeepers gave him a stuffed toy that he began dragging around everywhere he went.  (David Mareuil/Anadolu via Getty Images)

As a hand-reared infant, Punch was bullied and ignored by the established group of monkeys.

He was often seen huddled alone with his orange plush companion while the rest of the troop interacted.

BABY MONKEY CARRIES FAITHFUL STUFFED COMPANION EVERYWHERE HE GOES, DRAWING CROWDS AT ZOO

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In an official statement released Feb. 27, the Ichikawa Zoological and Botanical Garden detailed the meticulous care behind this process.

Previous viral videos showed Punch bullied by the rest of the troop, running to his plushy toy for comfort. (David Mareuil/Anadolu via Getty Images)

“From an animal welfare perspective, our primary goal is to reintegrate Punch with the troop,” the zoo said. 

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The strategy involved nursing Punch within the enclosure, so the troop could recognize him as one of their own, and pairing him with a gentle young female macaque prior to his full release to build his confidence.

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The latest footage, captured by X user @tate_gf, suggested the zoo’s patience is paying off. 

The video shows Punch seeking physical contact not from his toy, but from another monkey — eventually climbing onto its back for a vital social behavior for young macaques: the “piggyback ride.”

The zoo’s strategy appears to be paying off: Punch, shown at far left, was recently seen riding on the back of a fellow macaque. (David Mareuil/Anadolu via Getty Images)

While Punch still carries his stuffed toy for comfort during moments of perceived danger, the zoo remains optimistic about his progress. 

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The organization cited the successful 2009 case of Otome, another hand-reared macaque who eventually outgrew her stuffed toy, successfully integrated — and went on to raise four offspring of her own.

The zoo has had crowds coming to see Punch, with hundreds of people lining up to get inside to see the young star, according to reports. 

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“I’m hoping Punch has a good life like everybody else does, and think he’s a cute little guy,” one person commented online. 

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“Such a precious baby,” another person wrote. 

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ChatGPT could miss your serious medical emergency, new study suggests

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ChatGPT could miss your serious medical emergency, new study suggests

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This story discusses suicide. If you or someone you know is having thoughts of suicide, please contact the Suicide & Crisis Lifeline at 988 or 1-800-273-TALK (8255).

Artificial intelligence has been touted as a boon to healthcare, but a new study has revealed its potential shortcomings when it comes to giving medical advice.

In January, OpenAI launched ChatGPT Health, the medical-focused version of the popular chatbot tool. 

The company introduced the tool as “a dedicated experience that securely brings your health information and ChatGPT’s intelligence together, to help you feel more informed, prepared and confident navigating your health.”

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But researchers at the Icahn School of Medicine at Mount Sinai have found that the tool failed to recommend emergency care for a “significant number” of serious medical cases.

The study, published in the journal Nature Medicine on Feb. 23, aimed to explore how ChatGPT Health — which is reported to have about 40 million users daily — handles situations where people are asking whether to seek emergency care.

Artificial intelligence has been touted as a boon to healthcare, but a new study has revealed its potential shortcomings when it comes to giving medical advice. (iStock)

“Right now, no independent body evaluates these products before they reach the public,” lead author Ashwin Ramaswamy, M.D., instructor of urology at the Icahn School of Medicine at Mount Sinai in New York City, told Fox News Digital.

“We wouldn’t accept that for a medication or a medical device, and we shouldn’t accept it for a product that tens of millions of people are using to make health decisions.”

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Emergency scenarios

The team created 60 clinical scenarios across 21 medical specialties, ranging from minor conditions to true medical emergencies.

Three independent physicians then assigned an appropriate level of urgency for each case, based on published clinical practice guidelines in 56 medical societies.

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The researchers conducted 960 interactions with ChatGPT Health to see how the tool responded, taking into account gender, race, barriers to care and “social dynamics.”

While “clear-cut emergencies” — such as stroke or severe allergy — were generally handled well, the researchers found that the tool “under-triaged” many urgent medical issues.  

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The team created 60 clinical scenarios across 21 medical specialties, ranging from minor conditions to true medical emergencies. (iStock)

For example, in one asthma scenario, the system acknowledged that the patient was showing early signs of respiratory failure — but still recommended waiting instead of seeking emergency care.

“ChatGPT Health performs well in medium-severity cases, but fails at both ends of the spectrum — the cases where getting it right matters most,” Ramaswamy told Fox News Digital. “It under-triaged over half of genuine emergencies and over-triaged roughly two-thirds of mild cases that clinical guidelines say should be managed at home.”

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Under-triage can be life-threatening, the doctor noted, while over-triage can overwhelm emergency departments and delay care for those in real need.

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Researchers also identified inconsistencies in suicide risk alerts. In some cases, it directed users to the 988 Suicide and Crisis Lifeline in lower-risk scenarios, and in others, it failed to offer that recommendation even when a person discussed suicidal ideations.

“ChatGPT Health performs well in medium-severity cases, but fails at both ends of the spectrum.”

“The suicide guardrail failure was the most alarming,” study co-author Girish N. Nadkarni, M.D., chief AI officer of the Mount Sinai Health System, told Fox News Digital.

ChatGPT Health is designed to show a crisis intervention banner when someone describes thoughts of self-harm, the researcher noted.

OpenAI launched ChatGPT Health, the medical-focused version of the popular chatbot tool, in January 2026. (Gabby Jones/Bloomberg via Getty Images)

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“We tested it with a 27-year-old patient who said he’d been thinking about taking a lot of pills,” Nadkarni said. “When he described his symptoms alone, the banner appeared 100% of the time. Then we added normal lab results — same patient, same words, same severity — and the banner vanished.” 

“A safety feature that works perfectly in one context and completely fails in a nearly identical context … is a fundamental safety problem.”

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The researchers were also surprised by the social influence aspect.

“When a family member in the scenario said ‘it’s nothing serious’ — which happens all the time in real life — the system became nearly 12 times more likely to downplay the patient’s symptoms,” Nadkarni said. “Everyone has a spouse or parent who tells them they’re overreacting. The AI shouldn’t be agreeing with them during a potential emergency.”

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Fox News Digital reached out to Open AI, creator of ChatGPT, requesting comment.

Physicians react

Dr. Marc Siegel, Fox News senior medical analyst, called the new study “important.” 

“It underlines the principle that while large language models can triage clear-cut emergencies, they have much more trouble with nuanced situations,” Siegel, who was not involved in the study, told Fox News Digital. 

ChatGPT and other LLMs can be helpful tools, a doctor said, but they “should not be used to give medical direction.” (iStock)

“This is where doctors and clinical judgment come in — knowing the nuances of a patient’s history and how they report symptoms and their approach to health.”

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ChatGPT and other LLMs can be helpful tools, Siegel said, but they “should not be used to give medical direction.”

“Machine learning and continued input of data can help, but will never compensate for the essential problem – human judgment is needed to decide whether something is a true emergency or not.”

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Dr. Harvey Castro, an emergency physician and AI expert in Texas, echoed the importance of the study, calling it “exactly the kind of independent safety evaluation we need.”

“Innovation moves fast. Oversight has to move just as fast,” Castro, who also did not work on the study, told Fox News Digital. “In healthcare, the most dangerous mistakes happen at the extremes, when something looks mild but is actually catastrophic. That’s where clinical judgment matters most, and where AI must be stress-tested.”

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Study limitations

The researchers acknowledged some potential limitations in the study design.

“We used physician-written clinical scenarios rather than real patient conversations, and we tested at a single point in time — these systems update frequently, so performance may change,” Ramaswamy told Fox News Digital.

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Additionally, most of the missed emergencies happened in situations where the danger depended on how the condition was changing over time. It’s not clear whether the same problem would happen with acute medical emergencies.

Because the system had to choose just one fixed urgency category, the test may not reflect the more nuanced advice it might give in a back-and-forth conversation, the researchers noted. 

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ChatGPT Health is designed to show a crisis intervention banner when someone describes thoughts of self-harm. (iStock)

Also, the study wasn’t large enough to confidently detect small differences in how recommendations might vary by race or gender.

“We need continuous auditing, not one-time studies,” Castro noted. “These systems update frequently, so evaluation must be ongoing.”

‘Don’t wait’

The researchers emphasized the importance of seeking immediate care for serious issues.

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“If something feels seriously wrong — chest pain, difficulty breathing, a severe allergic reaction, thoughts of self-harm — go to the emergency department or call 988,” Ramaswamy advised. “Don’t wait for an AI to tell you it’s OK.”

The researchers noted that they support the use of AI to improve healthcare access, and that they didn’t conduct the study to “tear down the technology.”

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“These tools can be genuinely useful for the right things — understanding a diagnosis you’ve already received, looking up what your medications do and their side effects, or getting answers to questions that didn’t get fully addressed in a short doctor’s visit,” Ramaswamy said. 

“That’s a very different use case from deciding whether you need emergency care. Treat them as a complement to your doctor, not a replacement.”

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“This study doesn’t mean we abandon AI in healthcare.”

Castro agreed that the benefits of AI health tools should be weighed against the risks.

“AI health tools can increase access, reduce unnecessary visits and empower patients with information,” he said. “They are not inherently unsafe, but they are not yet substitutes for clinical judgment.”

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“This study doesn’t mean we abandon AI in healthcare,” he went on. “It means we mature it. Independent testing and stronger guardrails will determine whether AI becomes a safety net or a liability.”

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