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The U.S. Food and Drug Administration has received at least three reports of people being hospitalized after taking counterfeit versions of the wildly popular weight-loss drugs known as semaglutides. At least one of these reports includes mention of a counterfeit version of the Novo Nordisk medication Ozempic, CBS News reported. Ozempic and Wegovy, another semaglutide medication made by Novo Nordisk, have been tough to find for months as millions of Americans turn to them for weight loss. In total, 42 reports that mention the use of counterfeit semaglutide were submitted to the FDA’s Adverse Event Reporting System through the end of September, CBS News reported. Of those, 28 were classified as “serious,” with outcomes that included deaths. All were submitted to the FDA by Novo Nordisk. However, the records do not prove the counterfeits directly caused the adverse events. An FDA spokesperson told CBS News that the agency has “no new information to share regarding reports of adverse events” linked to semaglutide counterfeits. “The FDA will investigate any report of suspect counterfeit drugs to determine the public health risks and the appropriate regulatory response. The FDA remains vigilant in protecting the U.S. drug supply from these threats,” agency spokesperson Jeremy Kahn told CBS News. Meanwhile, Novo Nordisk has said that it is working with the FDA to make consumers aware of the counterfeits and how they differ… read on > read on >

Amid reports of more illnesses and additional product recalls, U.S. health officials have expanded their investigation into potentially lead-tainted pouches of apple cinnamon pureed fruit. The U.S. Food and Drug Administration said in an updated alert posted Friday that it has received reports of seven illnesses in at least five states possibly linked to contaminated puree. Two new companies, Schnucks Markets of St. Louis and Weis Markets of Sunbury, Pa., announced recalls of certain cinnamon applesauce products because they may contain high levels of lead. WanaBana of Coral Gables, Fla., had previously recalled all lots and expiration dates of its apple cinnamon fruit puree. Eating the contaminated products could result in “acute toxicity,” FDA officials said. Parents and caregivers should not buy or serve the cinnamon applesauce products, which are sold through multiple retailers, including Amazon, Dollar Tree, Weis Markets, Schnucks and Eatwell Markets. Children and others who have consumed the products should be tested for possible lead poisoning, the agency said. Just last week, the FDA issued an initial warning after four children in North Carolina were found to have high levels of lead in their blood that was linked to the WanaBana products, the FDA said. State health officials detected “extremely high” concentrations of lead in the pouches after analyzing multiple lots. Lead can enter food products through soil, air, water and industrial… read on > read on >

Nearly 30,000 pounds of dinosaur-shaped chicken nuggets have been recalled by maker Tyson Foods Inc. after customers discovered small bits of metal in some of the nuggets. There has been one reported minor oral injury associated with consumption of the nuggets, which were produced on Sept. 5, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) said in a statement it released Saturday. FSIS said it has received no additional reports of injury or illness from consumption of these products. Anyone who’s worried about an injury or illness should contact a healthcare provider, the agency said. The recall is specifically for the 29-ounce plastic bags of the product called Fully Cooked Fun Nuggets Breaded Shaped Chicken Patties, the FSIS said. Approximately 29,819 pounds of the Fun Nuggets are affected by the recall, and they were shipped to distributors in Alabama, California, Illinois, Kentucky, Michigan, Ohio, Tennessee, Virginia and Wisconsin. The plastic packages contain “Tyson FULLY COOKED FUN NUGGETS BREADED SHAPED CHICKEN PATTIES” with a Best If Used By date of SEP 04, 2024, and lot codes 2483BRV0207, 2483BRV0208, 2483BRV0209 and 2483BRV0210, the agency added. The products subject to recall also have the number “P-7211” on the back on the package. The problem was discovered after Tyson Foods notified FSIS that it had received consumer complaints reporting small metal pieces in the chicken patty… read on > read on >

Put down the saltshaker — especially if you’re at risk of type 2 diabetes. While the condition brings to mind the need to avoid sugar, a new study links it to frequent salt consumption. “We already know that limiting salt can reduce the risk of cardiovascular diseases and hypertension, but this study shows for the first time that taking the saltshaker off the table can help prevent type 2 diabetes as well,” said lead study author Dr. Lu Qi. He is chair and professor at the Tulane University School of Public Health and Tropical Medicine in New Orleans. “It’s not a difficult change to make, but it could have a tremendous impact on your health,” Qi said in a university news release. To better understand the link, the researchers surveyed more than 400,000 adults registered in the UK Biobank about their salt intake. Over almost 12 years on average, the research team saw more than 13,000 cases of type 2 diabetes develop. Compared to those who “never” or “rarely” used salt, participants who “sometimes,” “usually” or “always” added salt had a respective 13%, 20% and 39% higher risk of developing type 2 diabetes, according to the study. Why high salt intake would have this impact is not fully understood. Qi thinks salt encourages people to eat larger portions, which then increases the chances of developing… read on > read on >

Despite progress in recent decades, too many Americans still have dangerously high LDL cholesterol levels, and about a quarter don’t even know it, new research finds. That puts those people at risk for a longer span of artery clogging disease and increases their risk of heart attack and stroke, a new study says. “We are not talking about mildly elevated levels in this particular study,” said co-author Dr. Salim Virani, vice provost in the Office of Research and Graduate Studies at Aga Khan University in Karachi, Pakistan. “We are talking about levels where you need to start treatment right away.” Doctors may recommend diet and lifestyle changes for mildly elevated cholesterol levels, but someone with levels of 190 mg/dL or higher should also take cholesterol-lowering medication, experts say. A family history of heart disease further heightens the risk. “In those people, treatment needs to be started right away. If you don’t, then there’s a very high probability that a lot of these patients will end up having heart attacks and strokes at a very young age,” Virani said. Of course, you can only start treatment for high cholesterol if you know your cholesterol numbers are high. “That’s why it’s absolutely imperative that everybody should get their cholesterol checked and they should know their numbers,” Virani said. A simple blood test is all you need. Treatment… read on > read on >

WEDNESDAY, Nov. 1, 2023 (HealthDay News) — A new gene therapy for sickle cell disease was deemed safe by a U.S. Food and Drug Administration advisory panel on Tuesday, paving the way for full approval by early December. The FDA had already decided that the therapy, known as exa-cel, was effective. Developed by Vertex Pharmaceuticals of Boston and CRISPR Therapeutics of Switzerland, exa-cel frees patients from the excruciating symptoms of sickle cell disease. If approved by Dec. 8, as expected, it would become the first medicine to treat a genetic disease with the CRISPR gene-editing technique, CRISPR Therapeutics said in a news release. But it won’t be the only new treatment for the inherited condition coming down the pike: By Dec. 20, the FDA will also decide on a second potential cure for a disease that typically strikes Black people, a gene therapy crafted by Bluebird Bio, of Somerville, Mass. “We are finally at a spot where we can envision broadly available cures for sickle cell disease,” said Dr. John Tisdale, director of the cellular and molecular therapeutics branch at the National Heart, Lung and Blood Institute and a member of the advisory committee, the New York Times reported. In the case of exa-cel, the one-time treatment permanently changes DNA in a patient’s blood cells. How does it work? Stem cells are removed from a patient’s… read on > read on >

Adding warning labels to meat about its impact on climate and health could lower its consumption, a new study suggests. British researchers investigated what adding cigarette-style graphic warning labels to meat in a cafeteria setting might do. “Reaching net zero is a priority for the nation and the planet. As warning labels have already been shown to reduce smoking as well as drinking of sugary drinks and alcohol, using a warning label on meat-containing products could help us achieve this if introduced as national policy,” said study author Jack Hughes. Hughes conducted the research with his supervisors as part of his PhD program in the department of psychology at Durham University, in the United Kingdom. The study included a representative sample of just over 1,000 meat-eating adults who were split into four groups. They were shown pictures of hot meals a person might get at a cafeteria that contained a health warning label, climate warning label, pandemic warning label, or no label. An example set of meals could be a meat pasta bake, fish pasta bake, vegetarian pasta bake and a vegan pasta bake, the study authors noted. Participants were asked to make 20 separate decisions on different meal choices. They were also asked how anxiety provoking and believable they found the labels. The researchers measured future intentions to buy and eat the meal options,… read on > read on >

TUESDAY, Oct. 31, 2023 (HealthDay News) – Certain pureed fruit pouches from WanaBana may contain dangerous levels of lead, the U.S. Food and Drug Administration has warned. Parents and caregivers should not buy or serve WanaBana apple cinnamon fruit puree pouches to children, the agency said in a recent public health alert. Children who have consumed this product should be tested for possible lead poisoning, the agency added. The warning was issued after four children in North Carolina were found to have high levels of lead in their blood that was linked to these products, the FDA said. State health officials detected “extremely high” concentrations of lead in the pouches after analyzing multiple lots. This exposure could lead to “acute toxicity,” according to the FDA. Lead can enter food products through soil, air, water and industrial processes, according to the American Academy of Pediatrics. It’s not good for anyone, but can seriously harm children’s health. Lead can cause brain and nervous system damage, as well as slowed growth and development. WanaBana is based in Coral Gables, Fla. The company has issued a recall for all lot codes and expiration dates of the products, which are sold nationally. Among the places that carry these products are Amazon, Dollar Tree and Sam’s Club. More information The U.S. Centers for Disease Control and Prevention has more on the… read on > read on >

Time-restricted dieting may be a better way for people with type 2 diabetes to lose weight than counting calories, a new study suggests. Researchers found that people who only ate between noon and 8 p.m. each day lost more weight than those who reduced their calories by 25%. Both groups, however, had similar reductions in long-term blood sugar levels based on a test of hemoglobin A1C. The test shows blood sugar levels over the past three months. “It’s important to give people with type 2 diabetes more than one strategy to lose weight and decrease their HbA1C,” said lead researcher Krista Varady, a professor of nutrition at the University of Illinois, Chicago. “Some people find it difficult to count calories. Others don’t have weekly or monthly support and they need a dietary pattern that is simple to follow, such as watching the clock,” Varady added. In the United States, about 1 in 10 U.S. residents has diabetes, and that number is rising, the researchers said. It’s crucial to find more ways to control weight and blood sugar levels for these patients. While the study represents a “proof of concept” showing that time-restricted eating is safe for those with type 2 diabetes, Varady said people with diabetes should consult their doctor before starting this sort of diet. Also, “some medications for type 2 diabetes will lower… read on > read on >

Federal regulators are warning consumers to stop using eyedrops and gels from several major brands after finding unsanitary conditions in a manufacturing plant. Twenty-six eye care products are part of the alert. Contaminated products have the potential to cause eye infection and blindness because drugs applied to the eye can bypass some of the body’s defenses. Those concerning the U.S. Food and Drug Administration are branded CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up & Up and Velocity Pharma. The FDA urged the manufacturer to recall all lots of these products. CVS, Rite Aid and Target are pulling products from shelves and websites. Although there were no reports of infection, bacterial tests were positive in critical drug product areas of the plant. The FDA’s list of eye products to avoid is here. Patients and providers should report any issues to the FDA. Consumers should discard products involved in the recall at a drug take-back site. They can also check the FDA’s flush list to see if they can be safely discarded at home, the New York Times reported. Certain products — those branded Leader, Rugby and Velocity — may still be available for purchase in stores and online. Don’t buy them, the FDA advised. Rite Aid is removing “applicable Rite Aid branded products” from store shelves, a spokeswoman said. CVS “immediately… read on > read on >