Latest news with #MartinMakary
Fox News
3 days ago
- Health
- Fox News
More than 20 GOP attorneys general call on RFK Jr, FDA to reinstate safeguards for abortion drugs
Print Close By Landon Mion Published August 13, 2025 EXCLUSIVE: More than 20 Republican attorneys general are demanding that the Trump administration reinstate safety protocols for the abortion drug mifepristone, saying it poses "serious risks to women." In a letter obtained by Fox News Digital, 22 attorneys general called on Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drugs Administration head Martin Makary to bring back safeguards for the pills that were scrapped by the Obama and Biden administrations. "Recent comprehensive studies of the real-world effects of the chemical abortion drug mifepristone report that serious adverse events occur 22 times more often than stated on the drug's label, while the drug is less than half as effective as claimed. These facts directly contradict the drug's primary marketing message of 'safe' and 'effective,'" the letter reads, citing studies published earlier this year by the Ethics and Public Policy Center (EPPA), a Washington, D.C.-based advocacy group. The EPPA report claims the pill presents harm to women, causing 1 in 10 patients to experience a "serious adverse event," including hemorrhage, emergency room visits and ectopic pregnancy. FDA CHIEF HAS 'NO PLANS' FOR ABORTION PILL POLICY CHANGES BUT CONTINUES SAFETY REVIEW The letter, led by Kansas Attorney General Kris Kobach, comes after Kennedy Jr. asked Makary to review the latest data on mifepristone and its safety. "Based on that review, the FDA should consider reinstating safety protocols that it identified as necessary as recently as 2011 in its issuance of a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, but which were removed by the Obama and Biden administrations," the letter reads, adding that the drug should be taken off the market if safeguards cannot be put in place. "Alternatively, in light of the serious risks to women who are presently being prescribed this drug without crucial safeguards, and in the event the FDA is unable to reinstate the 2011 safety protocols for mifepristone, the FDA should consider withdrawing mifepristone from the market until it completes its review and can decide on a course of action based on objective safety and efficacy criteria," the attorneys general wrote. Sen. Josh Hawley, R-Mo., also sent a letter to Kennedy Jr. last month urging him to take immediate action to reinstate safety guardrails on mifepristone following the secretary's commitment to conducting a safety review of the drug. Makary had previously said that he had no plans to modify policies surrounding mifepristone but that the FDA would act if the data suggested there was a safety issue. Mifepristone, which is taken with another drug called misoprostol to end an early pregnancy, was first approved by the FDA in 2000 after "a thorough and comprehensive review" found it was safe and effective, according to the agency's website, which noted that periodic reviews since its approval have not identified new safety concerns. Last year, the Supreme Court rejected a challenge targeting the drug's availability. The plaintiffs had sought to restrict access to mifepristone across the country, including in Democrat-led states where abortion remains legal. The court did not rule on whether the FDA acted lawfully when it moved during the Obama and Biden administrations to ease the rules for mifepristone's use that had been established during the Clinton administration. Medication abortions made up more than half of all abortions in the U.S. health care system in 2023, according to a study by the Guttmacher Institute. MEDICAL GROUPS URGE FDA, KENNEDY TO REEXAMINE BROAD APPROVAL OF ABORTION DRUGS CLICK HERE TO GET THE FOX NEWS APP "Currently, a woman can obtain a mifepristone abortion by participating in only one telehealth visit with any approved healthcare provider (not necessarily a physician), ordering the drugs through a mail-order pharmacy, and self-administering them," the attorneys general wrote. "And the prescriber is only required to report an adverse event if he or she becomes aware that the patient has died." "The FDA's removal of these crucial safety protocols in 2016 (and in 2023) that only five years before the FDA considered necessary begs the question of whether the removal was motivated by considerations other than the safety of patients … The current FDA's dedication to the health and wellbeing of all Americans is encouraging, as is the much-needed review of mifepristone that Secretary Kennedy has promised," the letter concludes. Print Close URL
Reuters
08-08-2025
- Health
- Reuters
US FDA says country's IV, injectable saline shortage is resolved
Aug 8 (Reuters) - A shortage of intravenous and injectable saline solutions in the United States has now been resolved, U.S. Food and Drug Administration commissioner Martin Makary said on Friday. The shortage partly stems from Baxter International's (BAX.N), opens new tab North Carolina plant getting damaged in Hurricane Helene last year. At that time, the Marion, North Carolina site was producing 60% of the nation's supply of IV fluids and peritoneal dialysis solutions, amounting to 1.5 million bags daily, according to the American Hospital Association. A shortage of IV fluids, which provide nutrients to the body or replenish fluids lost due to injury or illness, had forced hospitals to curtail elective procedures.
Daily Mail
07-08-2025
- Health
- Daily Mail
Hidden addiction sweeping US as Americans hooked on substance being slipped into popular drinks
Doctors are warning Americans about the health effects of an increasingly popular supplement added to 'health' drinks and pills linked to a spate of deaths. Kratom first became popular in the US as an opioid withdrawal treatment, but more recently has gained ground as a wellness supplement for anxiety and stress. But the plant leaf extract - slipped into popular drinks and tablets sold in wellness stores and gas stations - has been linked to a range of serious side effects, including seizures, hallucinations and addiction. Several deaths from taking the supplement have also been reported. kratom is the name for the entire plant, and 7-Hydroxymitragynine, often abbreviated as 7-OH, is the chemical byproduct of the substance. While some products use the entire kratom plant, others are specifically made with high concentrations of 7-OH, which can be extremely dangerous. The Mayo Clinic has reported that studies have found some kratom sellers add more of the active ingredient to products than it naturally has. And recently, the FDA has requested that the Drug Enforcement Agency classify 7-OH products as illegal substances due to their potential for abuse, toxicity, and severe health consequences. And during a July press conference, FDA commissioner Martin Makary reiterated plans to initiate the sanction. Because kratom products lack clear labels, health experts warn that it's not possible to know how much kratom and 7-OH people who use it take. In April 2022, Jordan McKibban collapsed in his bathroom and never woke up after taking kratom powder mixed with lemonade. The 37-year-old purchased the supplement from an organic food store believing it to be an all-natural alternative to pain medications and other prescriptions. However, a coroner's report showed he later died of the 'toxic effects of mitragynine (Kratom)'. His mother, Pam Mauldin, is now pursuing a wrongful death lawsuit. The lawsuit points to a growing number of death certificates across the US in which kratom is formally identified as the cause of death. It also cites 2023 research finding kratom 63 times more deadly than other natural products sold to consumers. Similarly in 2021, Matthew Torres from Oregon died from severe seizures after taking the herbal substance. The 39-year-old carpenter was living in Beavercreek with his longtime girlfriend Meghan Gates and enjoyed creating hand-crafted décor items he would share with family and friends. Torres was found 'foaming at the mouth' by Gates in the wealthy Clackamas County area. She performed CPR on Torres until emergency responders arrived, but he was declared dead on May 27, 2021, one month before his 40th birthday. The coroner determined Torres' cause of death as 'toxic effects of mitragynine (7-OH)'. His mother, Mary Torres, sued the smoke shop that sold it to him and is seeking $10million in damages. He had been using kratom to manage his 'his pain and muscular ailments', the lawsuit said, as he thought it was not addictive and had fewer side effects than opioids. The supplement is made from the leaves of the South East Asian rainforest tree of the same name, and has been in use in cultures in Cambodia, Thailand and elsewhere since at least the 19th century. It can be boiled into a tea, smoked, chewed, mixed into drinks or placed into capsules, with many taking Kratom daily to help them quit opioids. The FDA warns against taking the supplement, saying it has not been approved for any use in the US. But data suggests that use of the supplement — which has also been called a 'legal opioid' and 'legal high' online — is continuing to increase. Data from the United States National Poison Data System showed there were just 11 poisonings with Kratom reported in 2011. But in the first seven months of 2018 alone, this figure had spiraled to 357 cases. A study in 2021 estimated that 1.7million Americans were taking the supplement - partially to help ease opioid addictions. Drugs including methadone and naltrexone are used to treat opioid addiction, but these can have side-effects like constipation, headaches, sweating and insomnia - prompting many to seek alternatives. Doctors have also warned that kratom can alter the hue of a patients' skin. They say this color change can persist for months, even when someone stops taking the supplement. Dr Heather Woolery-Lloyd, a dermatologist at the University of Miami, said in an interview with Medscape: 'This is something we will see more and more. 'Many of our patients think Kratom is a safe, herbal supplement, but often don't know it can have several side effects and can be addictive.' It isn't clear why Kratom may turn someone's skin blue, but scientists have previously suggested it may be linked to the supplement raising dopamine levels, which can boost melanin production - which may cause thicker patches of color to appear. It could also be linked to the supplement causing deposits around blood vessels, which may cause the blue patches - or any impurities in the supplement. The blue skin has only appeared on areas exposed to sunlight, which also has a link to increased melanin production. In a case revealed in February 2023 involving a 30-year-old man who came to doctors in Kansas, the patient said he started using Kratom to help with an opioid addiction. He took Kratom for four-and-a-half years before the discoloration occurred, telling doctors that it had appeared rapidly. He started to take Kratom for an opioid addiction, and did not have any other medical conditions and did not take any other drugs or supplements that could have caused the blue skin to emerge. In another case from 2022, a 54-year-old man who came to doctors in Washington state also revealed his skin had turned blue while taking Kratom. He said the color had appeared slowly on both his arms and face in areas exposed to sunlight. He had also been taking Kratom with orange juice three to four times a day for five years to help with his opioid addiction. The Drug Enforcement Administration (DEA) suggested banning Kratom in 2017 and listing it as a Schedule I substance alongside heroin, marijuana and LSD. But these plans were later abandoned following widespread protests over the move in many US cities. An estimated 2.1million Americans are currently struggling with an opioid addiction.
Yahoo
03-08-2025
- Health
- Yahoo
Products with opioid-like effects sold at gas stations may be banned as illicit substances
The Food and Drug Administration (FDA) is recommending banning a compound found in unregulated tablets, gummies and drink mixes sold online and at gas stations and convenience stores, the Trump administration announced this week. The substance, known as 7-OH, will be scheduled as an illicit drug if the Drug Enforcement Administration − a branch of the US Justice Department responsible for classifying drugs as controlled substances − approves the sanction after a review. "Dark innovations in chemistry have exacerbated the addiction crisis in this country," US Department of Health and Human Services Deputy Secretary Jim O'Neil told reporters during a Tuesday, July 29, press conference in Washington DC. "Synthetic opioids like carfentanill and the substance we're here to take action on today: 7-Hydroxymitragynine." O'Neil said 7-hydroxymitragynine, 7-OH, is deliberately addictive and a powerful opioid agonist many times more potent than morphine. Calling it "a recipe for public health disaster," O'Neill, said 7-OH products are often sold without warnings or controls. "We've seen a disturbing rise in reports of overdoses, poisonings and emergency room visits linked to products containing 7-OH,' O'Neil said. "These substances are often sold online or in convenience stores with no quality control, no dosage control and no warnings." 'They've killed thousands and thousands' During the press conference, FDA commissioner Martin Makary spoke alongside US Health and Human Services Secretary Robert F. Kennedy, Jr., as they announced they planned to send warning letters to companies for illegally marketing products containing 7-OH in an effort to combat the country's opioid addiction problem. 'We have a history in public health of being asleep at the wheel,' Makary said. 'Public health is supposed to prevent disasters, not just clean them up after they've killed thousands and thousands of people.' Which states felt tsunami waves? See list of where it hit after Russia earthquake What is 7-OH? The compound 7-OH is a naturally occurring substance in the kratom plant (Mitragyna speciosa), according to the FDA, but only a minor component comprising less than 2% of the alkaloid content in natural kratom leaves. "However, 7-OH demonstrates substantially greater mu-opioid receptor potency than kratom's primary alkaloid constituent mitragynine, as well as other classical opioids such as morphine," the FDA wrote in its findings. Mu-opioid receptors, found in the brain and spinal cord, are primarily responsible for pain relief and other opioid effects like euphoria and respiratory depression, according to research published on the National Institutes of Health's National Library of Medicine. Contributing: Adrianna Rodriguez Natalie Neysa Alund is a senior reporter for USA TODAY. Reach her at nalund@ and follow her on X @nataliealund. (This story was updated to include video.) This article originally appeared on USA TODAY: What is 7-OH? Opioid-like product may get banned by FDA Solve the daily Crossword
Yahoo
23-07-2025
- Health
- Yahoo
Talc Is Suddenly in the Spotlight. Is it Bad for You?
Credit - Photo-Illustration by TIME (Source Images: Liudmila Chernetska—Getty Images, LanaSweet/Getty Images) Federal health officials are scrutinizing a mineral—added to some makeup, medications, and foods—that many people have never thought twice about: talc. In a recent viewpoint article called 'Priorities for a New FDA,' published in the medical journal JAMA, Dr. Martin Makary, commissioner of the U.S. Food and Drug Administration (FDA), and Dr. Vinay Prasad, the FDA's Chief Medical and Scientific Officer, wrote that the FDA conducted an expert panel on talc in May. They also noted that some companies have removed talc from baby powder because it's a carcinogen. Johnson & Johnson, for example, stopped using talc in 2023 following more than 60,000 legal claims from ovarian cancer patients. The JAMA article added that talc remains common, since people still 'ingest it regularly' as an ingredient in various medications and foods. Despite the lawsuits, though, research hasn't confirmed whether talc causes cancer, especially when consumed through food. Meanwhile, companies continue to use talc in powders and cosmetics. Here's how people get exposed to talc, the potential health risks, and what to do about them. Talc and asbestos A naturally occurring mineral, talc consists of several elements like magnesium and silicon. When ground into fine particles, talc becomes talcum powder, which works to absorb moisture and soothe the skin. People have used cosmetics and powders with talc for more than a century. Before talc is mined by companies from deep within the earth, it mixes with another mineral, asbestos. This often results in talc's contamination with asbestos, which is proven to cause cancer. Talc, when laced with asbestos, is a carcinogen, especially when it's inhaled. Less clear is the cancer-causing potential of talc when it's not contaminated. In theory, talc on its own could drive cancer because its particles create inflammation when inhaled or migrating into the body after talc is applied to skin, according to Joellen Schildkraut, professor of epidemiology at Emory University. 'Inflammation can promote cancer,' Schildkraut says. 'Many studies have shown an association.' Some research shows that asbestos-free talc leads to tumors in animals, but animals reveal little about ovarian cancer in humans, Schildkraut says. Read More: The Race to Explain Why More Young Adults Are Getting Cancer Regardless, it's impossible for consumers to learn if products with talc are contaminated. Since the 1970s, companies have tested talc voluntarily, but the methods aren't sensitive enough to detect asbestos in their products—and the FDA doesn't require proof that they're asbestos-free. 'This means a lot of contaminated talc likely went through without anybody detecting the asbestos,' Schildkraut says. Using better tests, researchers have spot-checked whether cosmetics are asbestos-laced. From 1948 to 2017, two-thirds of these tests (conducted as part of litigation) came up positive for asbestos, typically in trace amounts. In 2020, the nonprofit Environmental Working Group found asbestos contaminated 15% of makeup samples with talc. In 2023, the FDA detected no asbestos in 50 talc-containing cosmetics. (The agency didn't reply to TIME's request for comment.) However, conclusions can't be drawn about the entire market from these checks because they involved small sample sizes, says Kaley Beins, a senior scientist at the Environmental Working Group. Later this year, the FDA is expected to finalize a new rule aimed at improving companies' testing methods. Ovarian cancer risk Some data show links between cancer of the ovaries and a specific type of talc exposure: the use of baby powder in intimate areas for personal hygiene. But the findings have been mixed. In a June letter to Makary, several talc researchers—some with ties to companies that make products with talc—criticized the recent FDA roundtable on talc's health impacts. The roundtable discussions, the authors wrote, were skewed because they 'included several paid plaintiff-side experts in talc-related litigation' without any defense-side experts. The letter says that studies involving several different groups of women have found only very weak associations with ovarian cancer. Schildkraut—an expert participant in the May roundtable without any ties to the lawsuits—notes that some of these studies involved relatively few women diagnosed with ovarian cancer. It's possible there simply wasn't enough data to yield stronger evidence. However, in 2020, scientists pooled together data from groups studied previously and still found no significant link. Read More: Scientists Are Finding Out Just How Toxic Your Stuff Is An important factor is that 'people may not be good at reporting their personal talc use,' says Katie O'Brien, a staff scientist at the National Institute of Environmental Health Studies and lead author of the 2020 research. In another study last year, she tried to correct for reporting errors while reanalyzing data from over 50,000 women and found that frequent users of talcum powder did have higher risk of ovarian cancer. 'This type of research doesn't determine causation,' says Schildkraut, who emphasized the same point during the public roundtable. 'But we do see a consistent relationship.' The self-report issue noted by O'Brien could extend to powder use for babies. 'People may not know whether baby powder was used on them,' O'Brien explains. Meanwhile, some laboratory research shows that human ovarian cancer cells, when exposed to talc, have more inflammation and cellular growth, mechanisms that can fuel cancer. Read More: Inflammation May Be the Culprit Behind Our Deadliest Diseases But Jennifer Permuth, an epidemiologist at the Moffitt Cancer Center who has served as an expert witness for J&J and signed the letter to Makary, questions how talc would migrate from where it's applied to cause cancer in the ovaries—without causing cancer in other organs along the way, such as the cervix. 'We would expect cancer to also develop in those other organs,' but studies find only weak links to these cancers, says Permuth. In a 2024 review, the World Health Organization found that, overall, evidence doesn't prove talc causes cancer, but it's 'probably carcinogenic.' The review focused on ovarian cancer 'because that's where the most evidence was' compared to other cancers, says Schildkraut, who served on the review committee. Meanwhile, the American Cancer Society states that, if there's an increased cancer risk, it's 'likely to be very small.' The E.U. has designated talc as a carcinogen, and it's expected to ban talc from cosmetics in 2027. Other potential health issues There's less research on other health issues related to talc. Some studies suggest that when miners repeatedly inhale talc, even if it's asbestos-free, their risk of lung cancer increases—but evidence on inhaling baby powder is more limited. In addition, a deadly cancer called mesothelioma is closely linked to asbestos exposure, though links to talc are less clear (partly because mesothelioma is extremely rare). Read More: What to Expect at a Mammogram Karen Selby, a patient advocate for the Mesothelioma Center at team of advocates, doctors, and attorneys supporting people with mesothelioma—works with patients who developed the disease decades after early-life exposure to cosmetics, she says. Every Christmas as a kid, Selby got a new box of cosmetic powder to play with. She'd cover herself and act like Casper the Friendly Ghost. She doesn't have mesothelioma, but recalling the haze of talc dust, she sometimes thinks, 'Holy cow, what was I doing to myself?' These makeup kits often have cheaper ingredients like asbestos-contaminated talc, despite that 'children are a susceptible group in environmental health,' says Beins, the Environmental Working Group scientist. 'I would try to keep talc away from them.' Safety precautions As researchers continue to study talc, Beins recommends using products with talc substitutes like cornstarch. (That's what J&J now uses instead of talc.) 'We can acknowledge the uncertainty and use safer alternatives,' Beins says. The Environmental Working Group has a database called Skin Deep that tracks which cosmetics contain ingredients like talc. Currently, the database lists about 150,000 products, and 8,000 have talc, Beins estimates. 'I wouldn't use talc personally,' Schildkraut says. 'It's not worth the risk because you don't need much exposure to asbestos to develop cancer.' Read More: 6 Things to Eat to Reduce Your Cancer Risk If possible, try passing on baby powders in general. Even if they lack talc, 'there may be other chemicals of concern,' such as ones added for fragrance or texture, O'Brien notes. If you've been exposed to talc for decades—whether through personal product use or occupations that often involve talc, like those in hair care—share this information with your doctors. They may recommend screening for ovarian cancer and other conditions, O'Brien says. What about food and medicine? Talc is commonly added to several foods like chewing gum and candy to keep them from sticking to wrappers and caking together. However, relatively few foods have talc. 'It's there and present sometimes, but it's not in a ton of food,' Beins says. To find which foods contain talc, you can search EWG's Food Scores, which tracks ingredients. Out of 80,000 products in the database, only 39 are currently listed to contain talc. In addition, the Environmental Working Group's Verified program certifies brands that meet its strictest health standards. To be certified, brands must disclose their ingredients, provide testing data, and avoid ingredients of concern. Products with talc can't be certified. Read More: Why Food Chemicals Are a Problem—And How to Reduce Your Exposure Talc is also added to some pill coatings because it helps pills travel smoothly through manufacturing equipment during production. But very little is known about cancer risk from talc in either food or pills. 'There's some thought that gastrointestinal issues might happen due to food exposure, because it's pro-inflammatory,' Beins says. However, this effect is mostly theoretical at this point. 'For the sake of public health, we shouldn't raise false alarms and make people scared of their food and medications,' says Permuth, who researches gastrointestinal cancer. 'Frequent users of talc-based personal care products or cosmetics are at the highest risk,' O'Brien says, adding that there's no medical reason for using these products. Whereas other established environmental risks like air pollution may be hard to avoid, O'Brien notes that for the most part, the 'use of talc products is something that individuals can control.' Contact us at letters@ Solve the daily Crossword
