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The U.S. Food and Drug Administration has uncovered counterfeit Ozempic shots in the legitimate U.S. drug supply chain, and is warning patients to be on their guard. The FDA said Thursday that it has seized thousands of counterfeit doses of Ozempic, the weight-loss drug manufactured by Novo Nordisk, but warned that more might still be available for purchase. Patients, practitioners and pharmacies are specifically warned not to sell or use Ozempic 1-milligram (mg) injections labeled with lot number NAR0074 and serial number 430834149057, the FDA said. People in possession of Ozempic doses meeting that description can report the counterfeit product directly to the FDA’s Office of Criminal Investigations, the agency said. The agency and the drugmaker are testing the seized products, but don’t have any information yet about the fake drugs’ identity, quality or safety. Five people have gotten sick from injections of the counterfeit Ozempic, but no cases have been serious, the FDA said. The sickened patients all suffered side effects consistent with legitimate Ozempic, like nausea, vomiting, diarrhea, abdominal pain and constipation. The rest of the Ozempic injection package is also counterfeit, including the needles, the injection pen label, the carton and the accompanying doctor and patient information, the FDA said. Because the needles are counterfeit, their sterility can’t be guaranteed and an injection presents an infection risk to anyone using the fake… read on > read on >

People are being maimed by unauthorized fat-dissolving injections meant to tighten up double chins and dissipate flab along the arms, thighs and stomach, the U.S. Food and Drug Administration warns. The shots are supposed to break down fat cells and reduce fat deposits in the areas around the injection sites. But adverse reactions from the unapproved injections are causing scarring, skin deformities, cysts, painful knots, and serious infections, the FDA said in an agency news release. The unapproved injections are being marketed under brand names like Aqualyx, Lipodissolve, Lipo Lab and Kabelline, the FDA said. Common ingredients in the injections include phosphatidylcholine (PPC) and sodium deoxycholate (DC). These ingredients have been used alone or together, and are sometimes referred to as “PCDC injections.” The FDA has received reports of consumers harmed by injections they received at clinics or med spas from attendants who might not have been properly licensed to give the shots. The agency also has heard from some consumers who bought the unapproved shots online and injected the drugs themselves. The FDA has approved only one injectable drug for dissolving fat, a prescription medication called Kybella, the agency said. The drug, which is deozycholic acid, is FDA-approved to treat double chins in adults. Deozycholic acid is a bile acid naturally produced by intestinal bacteria to help break down fats during digestion. The FDA… read on > read on >

Chances are you know at least one person who’s given up eating gluten. Maybe you’ve even given it up yourself. But who can really benefit from a gluten-free diet? “Gluten is one of the main proteins found in wheat, barley and rye,” said Dr. Joseph Levy, a pediatric gastroenterologist at Hassenfeld Children’s Hospital at NYU Langone, in New York City. “It’s actually a group of proteins and not a single component, but gluten is the general term.” In baking, it plays a key role. “Gluten is responsible for the way dough is able to rise when you put yeast in it,” Levy explained. “It’s the structure of gluten that makes baked goods light and crispy. If you try to cook with gluten-free flour it won’t have the same airiness. The dough is heavier, and the finished product will be flat and heavy.” But though gluten might make for a flaky croissant, it can cause a number of problems for certain people. New York City-based nutritionist Rachel Begun said that three types of people may not be able to eat products containing gluten: people with celiac disease, people with gluten sensitivity or intolerance and people with a wheat allergy. “Celiac disease is an autoimmune disorder, and when gluten is eaten, the body triggers an attack on the intestines,” Begun said. “Damage occurs over time, and nutrients… read on > read on >

At least 205 cases of lead poisoning linked to contaminated fruit puree pouches have now been reported in the United States, federal health officials report. That’s up from 125 cases in the last weekly tally, with 33 states now reporting poisonings, the U.S. Centers of Disease Control and Prevention said in its latest update. States reporting new cases to CDC include Alabama, Arkansas, Georgia, Maine, Michigan, Missouri, Montana, North Dakota, Pennsylvania, Virginia and Washington. How many cases have been reported in each state is unclear because the CDC has withheld state-specific counts, pointing to patient privacy, CBS News reported. The median age for cases in the investigation “is nearly 2 years old,” a CDC spokesperson told CBS News, though reports have come in for children as old as 9. Federal officials have urged state health departments to seek out cases of lead poisoning, which could be missed if children who ate the lead-tainted applesauce don’t get blood tests from their doctor for the toxic metal. AustroFoods, which makes the now-recalled WanaBana, Weis and Schnucks brand cinnamon-flavored applesauce pouches, said Monday it will reimburse customers for up to $150 for lead tests. Meanwhile, the FDA reported this week that cinnamon samples gathered at a facility in Ecuador linked to the tainted fruit puree pouches were found to contain levels of toxic lead that were 2,000 times… read on > read on >

A new treatment appears to reduce food allergies in children and teens, according to interim clinical trial results. A lab-made monoclonal antibody called omalizumab (Xolair) significantly increased the amounts of common foods that children could eat without sparking an allergic reaction, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) reported. The U.S. Food and Drug Administration is now reviewing an application for omalizumab to treat food allergies, based on these interim results. The data was collected on 165 children ages 17 and younger who have an allergy to peanut and at least two other foods, NIAID said in a news release. Those who received omalizumab injections could consume more peanut, egg, milk and cashew products without allergic reactions than those who received a placebo jab, results showed. Kids receive the drug in biweekly or monthly injections, according to an NIAID description of the clinical trial. These first-stage results have given NIAID the confidence to launch the next stage of clinical trials, which will be conducted at 10 locations across the United States. Omalizumab has already been approved by the U.S. Food and Drug Administration to treat allergic asthma, chronic hives and nasal polyps, according to the Cleveland Clinic. In 2017, a small study of 48 people found that 83% of participants could consume 2 grams of two food allergens after receiving omalizumab injections,… read on > read on >

Women struggling with fertility and using in vitro fertilization (IVF) to conceive sometimes turn to supplements for help. Unfortunately, a new study finds only weak evidence to support that strategy. In contrast, the same research found that the heart-healthy Mediterranean diet does boost the odds that a woman will become a mother. Compared to the fat- and sugar-rich Western diet, adopting a Mediterranean regimen appears to be a “straightforward approach” to boosting fertility, according to a team led by Roger Hart. He’s a fertility specialist and professor of obstetrics and gynecology at the University of Western Australia, in Perth. The new study was published Dec. 20 in Reproductive Biomedicine Online. As Hart explained in a journal news release, “nutritional supplements are usually not prescribed” for women using IVF. Instead, women typically try them out on their own. Such women are, therefore, “self-medicating” with supplements. “Our information is largely anecdotal but it’s quite clear from online IVF discussion forums that they [supplements] are widely used and of great public interest,” Hart said. But can supplements help women become pregnant? To find out, the new study examined the collected evidence regarding the following products: dehydroepiandrosterone (DHEA), melatonin, co-enzyme Q10 (CoQ1O), carnitine, selenium, Vitamin D, myo-inositol, Omega-3 and Chinese herbs. Researchers also analyzed data on various diets and whether they might help women on IVF conceive. … read on > read on >

Hospital coffee machines have received some side-eye as a potential source of spreading infection, but a new study debunks the belief. “To our great relief…a general ban on coffee makers doesn’t seem necessary,” concluded researchers led by Dr. Sarah Victoria Walker, head of the Institute for Clinical Microbiology and Hospital Hygiene in Ludwigsburg, Germany. For their study, German researchers swabbed 25 automatic capsule coffee makers and espresso machines. Of the machines, 17 were from break rooms and offices in a university hospital in Cologne, Germany, and the other eight were in the homes of staff members. All of the coffee makers had been in use for at least a year. Researchers swabbed them in five specific places – the drip tray, the outlet, the buttons, the handle of the water tank and the inside of the water tank. The researchers focused on what the World Health Organization calls its high-priority ESKAPE pathogens — Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species. Those bacteria all pose an increasing threat because they are antibiotic-resistant and can lead to fatal blood infections in a hospital setting. Unsurprisingly, bacterial growth was detected on every coffee machine. What’s more, hospital machines were about three times as heavily colonized with microbes as home machines, with 360 strains isolated from 72 swabs compared to 135 strains from… read on > read on >

The average U.S. adult eats a meal’s worth of snacks every day, a new study suggests. Americans average about 400 to 500 calories in snacks daily, often more than what they ate at breakfast, according to data from more than 23,000 people. These extra calories offer little in the way of actual nutrition, said senior researcher Christopher Taylor, a professor of medical dietetics with Ohio State University’s School of Health and Rehabilitation Sciences. “Snacks are contributing a meal’s worth of intake to what we eat without it actually being a meal,” Taylor noted in a university news release. “You know what dinner is going to be: a protein, a side dish or two,” Taylor added. “But if you eat a meal of what you eat for snacks, it becomes a completely different scenario of, generally, carbohydrates, sugars, not much protein, not much fruit, not a vegetable. So it’s not a fully well-rounded meal.” There’s one bright spot – people with type 2 diabetes tended to eat fewer sugary foods and snacked less overall than either those without diabetes or with prediabetes. “Diabetes education looks like it’s working, but we might need to bump education back to people who are at risk for diabetes and even to people with normal blood glucose levels to start improving dietary behaviors before people develop chronic disease,” Taylor said. For… read on > read on >

Cinnamon used in applesauce pouches that have been tied to high lead levels in kids may have been deliberately tainted with the toxic element, a source at the U.S. Food and Drug Administration says. “We’re still in the midst of our investigation,” Jim Jones, the FDA’s deputy commissioner for human foods, told Politico. “But so far all of the signals we’re getting lead to an intentional act on the part of someone in the supply chain and we’re trying to sort of figure that out.” The applesauce pouches under recall so far are from three brands — Weis, WanaBana and Schnucks. Each is tied to the same manufacturing facility in Ecuador, which the FDA said it is now inspecting. “My instinct is they didn’t think this product was going to end up in a country with a robust regulatory process,” Jones said. “They thought it was going to end up in places that did not have the ability to detect something like this.” As of the latest FDA update on Dec. 12, 65 children under 6 years of age had been diagnosed with symptoms of lead poisoning tied to the recalled applesauce. According to Politico, the FDA suspect the deliberate adulteration of cinnamon included in the applesauce products was “economically motivated.” Typically, that involves boosting the perceived quality of a product while producing it at… read on > read on >

Federal agents have seized more than 1.4 million illegal vaping products being smuggled into the United States from China. A three-day operation at Los Angeles International Airport resulted in the seizure of 41 shipments of illegal e-cigarettes worth more than $18 million, the U.S. Food and Drug Administration said. The products included the hugely popular brand Elf Bar, as well as other flavored vapes that have been banned by the FDA. The seized vaping products will be destroyed, the FDA said. Many of the products were intentionally mis-declared as items like toys, shoes or household items in an attempt to evade customs, the FDA said. “Those shamelessly attempting to smuggle illegal e-cigarettes, particularly those that appeal to youth, into this country should take heed of today’s announcement,” Brian King, director of the FDA’s Center for Tobacco Products, said in an agency news release. “Federal agencies are on to their antics and will not hesitate to take action.” “The significant value of these seized products is also a sobering reminder to these bad actors that their time and money would be better spent complying with the law,” King added. The Campaign for Tobacco-Free Kids applauded the news, noting that Elf Bar was the most commonly used brand among young vapers in the 2023 National Youth Tobacco Survey. “This is the strongest enforcement action the government has… read on > read on >