Sarepta's Elevidys Halted at Children's Hospital Los Angeles
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Children's Hospital Los Angeles paused the use of Sarepta Therapeutics Inc. 's gene therapy for Duchenne muscular dystrophy in the wake of rising safety concerns about liver toxicity, adding to mounting challenges for the drugmaker.
The leading children's hospital said it halted the treatments effective July 18, the same day the Food and Drug Administration requested that Sarepta stop distributing the drug, Elevidys. Sarepta has refused to stop shipments.
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Yahoo
4 minutes ago
- Yahoo
US health officials crack down on kratom-related products after complaints from supplement industry
WASHINGTON (AP) — U.S. health officials are warning Americans about the risks of an opioid-related ingredient increasingly added to energy drinks, gummies and supplements sold at gas stations and convenience stores, recommending a nationwide ban. The chemical, known as 7- hydroxymitragynine, is a component of kratom, a plant native to Southeast Asia that has gained popularity in the U.S. as an unapproved treatment for pain, anxiety and drug dependence. In recent months, dietary supplement companies that sell kratom have been urging the Food and Drug Administration to crack down on the products containing 7-OH, portraying it as a dangerously concentrated, synthetic form of the original ingredient. The FDA action 'is not focused on natural kratom leaf products," according to a statement Tuesday by the U.S. Department of Health and Human Services. The agency said it was releasing a report to educate about the risks of '7-OH and its distinction from the kratom plant leaf.' Regulators are also recommending that the ingredient be placed on the federal government's most restrictive list of illegal drugs, which includes LSD and heroin. '7-OH is an opioid that can be more potent than morphine," said FDA Commissioner Marty Makary. "We need regulation and public education to prevent another wave of the opioid epidemic.' The agency's recommendation will be reviewed by the Drug Enforcement Administration, which sets federal rules for high-risk drugs including prescription medicines and illicit substances. A national ban wouldn't take effect until the agency drafts and finalizes new rules governing the ingredient. Federal regulators have been scrutinizing kratom for about a decade after reports of addiction, injury and overdose. But users and distributors have long opposed efforts to regulate it, saying kratom could be a safer alternative to opioid painkillers that sparked the ongoing drug addiction epidemic. Last month, the FDA issued warning letters to seven companies selling drinks, gummies and powders infused with 7-OH. Regulators said the products violated FDA rules because they have not been evaluated for safety and, in some cases, claimed to treat medical conditions, including pain, arthritis and anxiety. Supplement executives quickly applauded the move. The FDA "demonstrated the exact kind of data-driven, proactive regulatory excellence needed to safeguard unwitting consumers across the U.S.,' said Ryan Niddel of Diversified Botanics, a Utah-based company that sells kratom supplements. An industry group, the American Kratom Association, has lobbied Congress for years against restrictions on the plant. Legislation supported by the group would prohibit the FDA from regulating kratom more strictly than food and dietary supplements. In recent years, the association has lobbied at the state level for bills that limit synthetic 7-OH products. On Tuesday, a rival group that supports the availability of 7-OH drugs criticized the government's move, pointing to the influence of kratom suppliers. 'Big kratom trade groups have spent years blaming 7-OH for harms caused by their own unregulated products, because it threatens their market share,' the Holistic Alternative Recovery Trust stated in an emailed message. Nearly a decade ago, the federal government came close to banning kratom. In 2016, the DEA announced plans to add it to the government's most restrictive schedule 1, reserved for drugs that have no medical use and a high potential for abuse. But the plan stalled after a flood of public complaints, including a letter signed by more than 60 members of Congress. The FDA then began studying the ingredient, concluding in 2018 that kratom contains many of the same chemicals as opioids, the addictive class of drugs that includes painkillers like OxyContin as well as heroin and fentanyl. Since then, FDA regulators have continued to issue warnings about cases of injury, addiction and death with kratom supplements, which are usually sold in capsules or powders. In recent months, the FDA has also issued warnings on other unapproved drugs sold as supplements or energy drinks, including the antidepressant tianeptine. Sometimes referred to collectively as 'gas station heroin,' the drugs have been restricted by several states, but they are not scheduled at the federal level. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. Matthew Perrone, The Associated Press
Yahoo
4 minutes ago
- Yahoo
Your complete guide to getting menopause help online
Menopause is having a moment. Celebrities are speaking up, the menopause wellness industry is booming and there's a good chance your Insta feed is overflowing with #menobelly content. But there's still one place where "menopause" remains something of a whisper: the doctor's office. Scratch that — more often than not, it's your brick-and-mortar doctor's office where menopause is still treated like a side note, if it's addressed at all. Enter the age of menopause telehealth — where online clinics are reshaping how women access midlife care, one video visit at a time. Roughly 42% of women now use telemedicine, according to the latest data from the Centers for Disease Control and Prevention. And specialized menopause clinics — like Midi Health, MenopauseRX and others — have exploded onto the scene in response, with multiple startups launching in just the past few years. As Dr. Sherry Ross, ob-gyn at Providence Saint John's Health Center in Santa Monica, Calif. and author of She-ology, puts it, "This surge in virtual menopause care solves many of the ongoing problems with our current health care system." But are online menopause clinics sacrificing quality for convenience? Here's what you need to know: Why you might need a menopause specialist — not just your regular doctor You have a doctor. You trust them. Maybe they delivered your baby, got you through your annual Pap with nary a wince or called in your UTI scripts approximately a zillion times. But when it comes to perimenopause and menopause? Even the most dependable physician might not be up to speed. Carolyn G. from Napa, Calif., didn't even bother reaching out to her regular doctor when her menopausal symptoms flared. "A health coach recommended Midi, a telehealth option, and that's where I found what I needed — someone who specialized specifically in menopause care." Her story isn't unusual. A 2025 survey of 1,000 women aged 45 to 60 found that nearly 71% said their doctor didn't adequately prepare them for menopause — or offer a thorough discussion of treatment options. Another 1,000 person survey found that 50% of women who have discussed menopause with their provider said they were the ones who initiated the conversation — not their physician. Part of the problem? Most medical training barely touches menopause. According to a 2019 Mayo Clinic report, only 7% of medical residents said they felt prepared to manage it. To put it simply, "there's an urgent need for appropriate menopause care, and telehealth platforms can fulfill some of this need," says Dr. Robin Noble, a gynecologist in Portland, Maine, and the chief medical adviser at Let's Talk Menopause, a nonprofit working to improve menopause care. How menopause telehealth works — and when it's worth it Before the pandemic, nearly every woman — 92% — wanted to see their menopause provider face-to-face. By 2022, that number slid to 71%, according to a report in the journal Patient Related Outcome Measures, reflecting a clear trend: Women are becoming more comfortable turning to screens for symptom relief, answers and evidence-based support. And providers get it. "Same-day care in the comfort of your home, affordable and flexible scheduling and easy access to knowledgeable providers — that's a big win when you need life-changing guidance through the hormonal chaos of menopause," says Ross. But it's not just about convenience. Telehealth allows health care providers to reach women in menopause in underserved areas where there's a paucity of certified menopause specialists, as noted in a video released by the Menopause Society. That accessibility — and focus — is a major part of the appeal. "Theoretically, most menopausal symptoms can be managed virtually," says Dr. Stephanie Faubion, medical director of the Menopause Society. Those include many of the most common struggles, such as: Hot flashes Night sweats Sleep problems Mood changes Weight gain Low libido Vaginal dryness (in some cases) For many women, virtual care has been a turning point. Two years after Carolyn G. started her menopause telehealth journey, she reports that the care she's received has been "nothing short of transformative." When virtual menopause care can fall short Still, not every woman going through menopause can — or should — turn to online clinics for guidance and treatment. According to an editorial in the journal Climacteric, many women with co-morbidities don't fit in the menopause-only telehealth model. Telemedicine simply can't replace regular clinical examinations and in-depth screenings. It's nearly impossible for a virtual menopause visit to properly address acute clinical problems such as vaginal discharge, unexpected bleeding or breast lumps. Noble agrees, says that "abnormal bleeding, postmenopausal bleeding, vaginal discharge and breast masses are symptoms that should always be managed in person." These symptoms can point to more serious issues that require a physical exam or additional testing. Even vaginal dryness, which is often addressed virtually, has its limitations. "Symptoms like vulvar dryness or irritation may be caused by other conditions — such as vulvar dermatoses — that can't be properly diagnosed without an in-person visit," says Faubion. Ross adds that when symptoms are complex or unclear, it's safest to see someone face-to-face. Not sure when to see someone in person? Here's when it matters most: Irregular or postmenopausal bleeding Painful intercourse Vaginal irritation or discharge Urinary issues Breast or skin changes Dizziness or vertigo Persistent headaches Unexplained fatigue How to find the best menopause telehealth provider for you While dutifully typing "how to find a menopause telehealth provider" into your search engine is certainly one way to start looking, it may not be the best strategy. Here's how to skip the digital noise and find care that actually fits. Contact your insurance provider. Not appealing, we know! But knowing what's covered and what's not is a great starting point. Aetna, for example, covers virtual visits to both Midi and Gennev, but you'll still need to double-check your own benefits because coverage varies wildly. Also ask whether lab work and prescription therapies are included. Look beyond teleclinics: While it's no doubt a struggle to locate an in-person menopause specialist, many traditional providers offer telehealth appointments. In fact, the CDC reports that nearly 60% of medical specialists now use telemedicine for at least a quarter of their patient visits — and a solid 1 in 4 use it for half or more. That means your local gynecologist — or meno rock star, if you're lucky — might already offer virtual care. Even Faubion, who's also director of the Mayo Clinic Center for Women's Health in Jacksonville, Fla., offers video visits for her patients with menopause. Find a certified specialist. "At a minimum, your provider needs to have a medical license, and ideally they should be certified in menopause management by the Menopause Society, known as a Menopause Society Certified Practitioner (MSCP)," says Faubion. To locate a care provider who fits the bill, search the Menopause Society directory. It's not exhaustive, but it's one of the best places to start. Check for smart safeguards. "Telehealth companies should have clear policies on data privacy and storage, security measures for patient-doctor communication, secure login protocols, compliance with the Health Insurance Portability and Accountability Act (HIPAA) and easy customer support access," says Ross. Ask around. Look beyond the homepage hype — real users will tell you how responsive the care team is, whether prescriptions were personalized and if the costs were what they expected. Start by asking friends, family and even colleagues if you're comfortable. Then, of course, Google the platform name plus 'reviews,' checking resources like Trustpilot and Reddit. Red flags to watch for in online menopause clinics Online menopause care can be convenient and effective — but not every clinic is created equal. Here's what to watch for. Rushing through your medical history: "From what I've seen, most online platforms don't take a good medical history," says Faubion. Quality menopause care starts with understanding your complete health picture, including a comprehensive review of your physical and mental health history, current symptoms and any medications you're taking. Dropping the ball with follow-ups: "These platforms can help with access, but they don't always deliver ongoing follow-up — and that's a problem," says Noble. Proper care requires regular monitoring of your progress as well as communication with your broader care team when needed. Lacking teamwork: "My biggest concern is not the online model itself — it's the lack of integration with a patient's other medical care that's troubling," says Faubion. Coordinated care matters, especially for patients managing other health issues alongside menopause. Without it, important context can be missed — and that can affect treatment safety and outcomes. Pushing unnecessary testing: Here's something that might surprise you: hormone testing is neither required nor recommended before starting hormone therapy, according to experts. That's because there's no ideal targeted hormone level that determines safe and effective HRT dosage. In most cases, symptoms — not lab results — should guide treatment. Always ask how a test will inform your treatment. Pressuring you to buy their products: "The emphasis should always be on patient care, education and treatment management — not on selling supplements or in-house products," says Ross. "If you feel pressured to buy in-house products over receiving quality care, you may not be using the right company for your medical needs." Instead, look for companies that send prescriptions to independent pharmacies — it's a good sign that the provider is prioritizing your health over their sales. How to prepare for a menopause telehealth visit Telehealth works best when you're prepared. Before your appointment, make notes about: Bothersome symptoms Medical and family history Current medications Any recent test results that might be relevant At the same time, "think about your goals and preferences — are you open to hormone therapy? Do you want lifestyle-focused recommendations?" says Noble. "Having clarity going in makes the visit far more productive." Once you're on, ask what to expect from treatment, what to do if side effects come up and whether follow-ups are built in. "Patients should ask whether the provider will monitor for effectiveness and communicate with their existing care team," says Faubion. "Also ask if they'll review or order routine screenings like mammograms and Pap smears, and follow up on the results if needed." The more you bring to the table, the more useful and personalized your virtual visit will be. Best menopause telehealth clinics to consider There are a lot of online menopause clinics out there so finding the right one takes some effort. While this is in no way a complete list, here are a handful that we think are worth looking into: Midi Health Midi earns an impressive "Excellent" rating from Trustpilot and is staffed by clinicians trained specifically in menopause and midlife health. They accept insurance (including Medicare in some states), offer built-in follow-up and care coordination and allow prescriptions to be filled at the pharmacy of your choice. Plus, Midi is available in all 50 states. While most reviewers praise Midi's care and service — including Carolyn, above — one Trustpilot user noted it may be better suited for those seeking hormone therapy. "I have a special circumstance of a blood clot disorder, so unfortunately HRT isn't helpful for me," she wrote. "I felt they really focused on pushing hormones." MyMenopauseRx While not as wide-reaching as Midi, MyMenopauseRX (available in 29 states) offers appointments with certified menopause specialists, they accept insurance and allow patients to fill prescriptions at their preferred pharmacy. The fact that "Rx" is in the name is a little off-putting — and some reviewers do feel like HRT is being heavily promoted — however, most of their Google reviews are positive, with one noting: "The level of compassion and care was impeccable. I wasn't treated like a number." Gennev Available in all 50 states and accepted by insurance, Gennev offers virtual visits with board-certified, menopause-trained doctors who. if needed, can recommend follow-up care with menopause-trained dietitians or mental health specialists. And prescriptions be filled by outside pharmacies. While they do sell some branded wellness products, this isn't central to their operation. Gennev's limited Trustpilot reviews leave a lot to be desired, but feedback in Real Patient Reviews is stellar. Maven Clinic Maven Clinic is not quite like the others. While it does deliver online menopause care, it's through your employer and health plan benefits. That means you can't sign up directly unless it's offered through your job. But if it is, you get access to menopause-trained ob-gyns, NPs, therapists, pelvic floor physical therapists, nutritionists and more. Right now, Maven's menopause program is offered by around 40 employers (including Amazon, BuzzFeed and, yes, Yahoo). If it's part of your benefits, it's a strong option to consider. As one Reddit user noted: "My Maven doctor was the first doctor to actually listen to me!" Menopause telehealth: What to keep in mind moving forward Samantha S. of Studio City, Calif., started her HRT journey with Midi Health after a colleague referral turned into a symptom breakthrough: "I don't think I would have addressed my symptoms or started HRT if I hadn't discovered Midi," she says. "They educated me, enabled me to jump in, figure out what I needed and get started with treatment ASAP." Telehealth got her in the door — but after a couple of years, she made the switch to in-person care with a gynecologist. "I ultimately just felt like she had more experience and knowledge, and preferred working with an MD who had a higher level of training," Samantha S. says. Her doctor helped fine-tune her treatment, adjusting dosage and delivery to better suit her needs. Noble isn't totally surprised. "Forming a trusted partnership between patient and healthcare provider is extremely important in an area of medicine like menopausal care, that is truly so nuanced and individualized," she says. "And it's simply more challenging to build that trust via telemedicine — but that doesn't mean it can't work." In the end, virtual menopause care can be a powerful starting point — one that gets you answers faster and helps you feel seen. But staying open to in-person expertise — especially as your care evolves — can make all the difference to your long-term results and experience as you navigate this phase of life. Meet the experts Stephanie Faubion, MD, director of the Mayo Clinic Center for Women's Health in Jacksonville, Fla., and medical director of the Menopause Society Sherry Ross, MD, ob-gyn at Providence Saint John's Health Center in Santa Monica, Calif., and author of She-ology: The Definitive Guide to Women's Intimate Health. Period. Robin Noble, MD, a gynecologist in Portland, Maine, and chief medical adviser at Let's Talk Menopause, a nonprofit working to improve menopause care Our health content is for informational purposes only and is not intended as professional medical advice. Consult a medical professional on questions about your health.
Gizmodo
6 minutes ago
- Gizmodo
A Rare Flu Complication Is Killing More U.S. Children
A rare, life-threatening complication caused by the flu seems to be surging among kids. Research out today finds that dozens of children developed influenza-associated acute necrotizing encephalopathy (ANE) over the past two years, a third of whom died as a result. Researchers at Stanford Medicine led the study, published Thursday in JAMA. Collecting reports from other doctors and hospitals across the country, they identified 41 cases of ANE since 2023, along with 11 deaths. The researchers argue that the condition should be systemically tracked in the U.S. from now on. Flu Cases Are Surging—Here's Why This Season Is So Unusual 'ANE occurs when the body's immune response to influenza triggers widespread brain inflammation, particularly targeting the thalamus—a critical brain region that controls consciousness and many vital functions,' study author Keith Van Haren, a pediatric neurologist at Stanford Medicine, told Gizmodo. 'Children are disproportionately affected, possibly due to their developing immune systems and genetic factors.' ANE is typically very rare, with Van Haren and his colleagues usually only seeing a single case every few years. But earlier this January, they came across several at their center. They also heard reports of increased cases from nearby pediatric centers in the state. Curious, the team issued a nationwide call to infectious disease and flu specialists for any and all recent reports of ANE. All told, they documented cases from 23 hospitals dating back to October 2023. This spike is likely tied to the circulation of more severe flu strains seen during that time. 'While we can't definitively prove an increase in ANE cases, the clustering of reports and severe flu season designation suggest this may represent a genuine rise,' Van Haren said. The median age of these cases is five years, with most involving children who had no preexisting health conditions. In addition to the 11 deaths, roughly two-thirds of children developed moderate to severe disability that was still present 90 days later. Notably, only 16% of victims were vaccinated against the flu. The Centers for Disease Control and Prevention also received a glut of ANE reports during the recent 2024-2025 flu season. But in a February paper that examined historical data going back 15 years, CDC scientists couldn't conclusively determine whether this past season represented a real spike in cases. Both the CDC report and the current study authors note that influenza-associated encephalopathy in general (ANE being the most severe form) isn't a nationally notifiable condition, meaning doctors aren't obligated to report cases to health departments. So if nothing else, Van Haren and his team are pushing for that to change, since better tracking would make it easier to spot rising cases moving forward. 'Typically, the U.S. CDC is best situated to undertake these efforts, which involve a high degree of collaboration across hospitals and public systems around the country,' Van Haren said. Unfortunately, that might be easier said than done for the time being. The current Trump administration has hollowed out its public health agencies, with the CDC in particular having shed nearly one-quarter of its staff this year. RFK Jr.'s Baseless Purge of CDC Vaccine Panel Alarms Public Health Experts Van Haren is hopeful that clinical trials in the future will figure out which immunotherapies work best for ANE, since there's no clearly established optimal treatment as of yet. And dire as the overall public health situation is, there is something we can all do to further lower the rare danger of ANE: Get the seasonal flu vaccine. 'The most important message is prevention: seasonal influenza vaccination significantly reduces the risk of severe complications like ANE,' Van Haren said. 'Parents should ensure their children receive annual flu vaccines and seek immediate medical attention for any child with flu symptoms who develops altered mental status, seizures, or severe neurological changes.' For now, at least, the White House hasn't directly gone after the flu shot, though Health Secretary RFK Jr. did recently sign off on removing a small minority of flu vaccines containing thimerosal, an ingredient antivaxxers have long and wrongly blamed for causing autism.
