Ozempic, a type 2 diabetes drug that has increasingly been used to help with weight loss, will now be labeled as having the potential to block intestines. The U.S. Food and Drug Administration recently made the label update for the drug made by Novo Nordisk, without directly citing Ozempic as the cause for this condition. “Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the label reads. The side effect, known by the medical term “ileus,” is also listed on labels for the weight-loss drug Wegovy, also made by Novo Nordisk, and in the diabetes medication Mounjaro, made by Eli Lilly, CBS News reported. Both Ozempic and Wegovy are known generically as semaglutide. Among more than 8,500 reports of gastrointestinal disorders after using semaglutide medications through June 30, ileus is mentioned in 33 cases, including two deaths, CBS News reported. The two pharmaceutical companies that make these medications are both being sued for claims that the drugs can cause a similar health issue known as gastroparesis, or stomach paralysis, CBS News reported. More information The U.S. National Library of Medicine has more on ileus. SOURCE: CBS News  read on >

TUESDAY, Sept. 26, 2023 (HealthDay News) – A Pfizer plant that makes vital drugs, anesthesia and hospital supplies has restarted production after a 10-week shutdown. The plant, located in Rocky Mount, N.C., sustained severe tornado damage on July 19, when roofs were ripped off and medications tossed around. “This expedited restart is a proud achievement for the Rocky Mount team; however, it is only the first step toward full recovery for the plant, as Pfizer restarts production through a phased approach, with full production across the site’s three manufacturing suites anticipated by the end of 2023,” the company said in a statement issued Monday. “Production restart has been prioritized based on patient need and inventory levels. There are approximately 13 medicines in production on the lines that have restarted, including products that are currently available through Pfizer’s emergency ordering process,” the company added. “The first shipments of these medicines to distribution centers are anticipated in the fourth quarter of 2023. While manufacturing has resumed, it is important to note that some medicines may not be back in full supply until next year.” Most of the damage happened at the plant’s storage facility rather than its medication production areas, Pfizer said. The storage area contained raw materials, finished medications and packaging supplies, CBS News reported. Established in 1968, the Rocky Mount plant has more than 3,000…  read on >  read on >

Kraft Heinz said it is recalling over 83,000 packs of its Kraft Singles American processed cheese slices because of a packaging defect in the plastic that wraps the cheese slices. A temporary issue developed on one of the wrapping machines, making it possible for a thin strip of individual film to stay on the cheese slice after the wrapper is removed. Having this film on the cheese could be unpleasant, the company said, and may cause gagging or be a choking hazard, according to a recall notice posted on the U.S. Food and Drug Administration website. Kraft Heinz discovered the problem after getting several consumer complaints about it. This included six complaints of customers saying they choked or gagged on the product. Still, no injuries or serious health issues have been reported. The company said it has fixed the machine with the issue and has inspected all other processing machines. Consumers should not eat the affected slices and should instead return them to the store where they were purchased for an exchange or refund. Contact Kraft Heinz from 9 a.m. to 6 p.m. ET, Monday through Friday, at 1-800-280-8252 to check on whether the cheese slices you purchased are part of the recall and to receive reimbursement. The recalled cheese packages are labeled 16 oz. Kraft Singles American Pasteurized Prepared Cheese Product with an individual…  read on >  read on >

A new government report finds that federal regulators need to do more to help in the battle to keep kids and teens off tobacco. Among the report’s findings were that the U.S. Food and Drug Administration needs to get tough on retailers selling tobacco to youth and should improve its oversight of online retailers. The FDA should also work with the Bureau of Alcohol, Tobacco, Firearms and Explosives to help stop online tobacco sales to children, according to the report from the Office of the Inspector General (OIG). “Responding effectively to serial violators remains a challenge for FDA,” the report stated. “The small number of retailers that repeatedly violate the Tobacco Control Act are often not subjected to more punitive actions. This risks undermining FDA’s efforts to control youth access to tobacco and enforce other restrictions on tobacco intended to safeguard public health,” according to the report. The agency needs to prioritize enforcement actions against retailers with a history of noncompliance, the OIG said. The FDA plans to discuss stricter enforcement with internal experts by November, CNN reported, and the agency agreed that inspections are a key part of keeping kids from smoking or vaping. The FDA did more than 1 million inspections between 2010 and 2020 looking for underage sales, CNN reported. The agency inspected about 74% of 360,000 stores at least once. It…  read on >  read on >

Highly processed packaged foods and drinks may be quick, cheap and tasty, but new research suggests they’re also likely to up your risk for depression. Among big consumers of ultra-processed foods, depression risk may rise by as much as 50%, the new study found, particularly when those foods are artificially sweetened. “Given what we know about these foods and the important role of diet in mood, we were not surprised to find this association,” said study author Dr. Andrew Chan, vice chair of gastroenterology at Massachusetts General Hospital, and a professor of medicine at Harvard Medical School. At issue, he said, are foods that are “highly altered, often through industrial processes such as hydrogenation.” Hydrogenation is a chemical manufacturing process that significantly increases the amount of trans fat found in foods. Researchers have repeatedly linked trans fat intake to an increased risk for heart disease. The study looked at “ultra-processed” grain foods, sweet snacks, ready-to-eat meals, desserts, sauces, processed dairy products, savory snacks, processed meat, beverages, and/or artificial sweeteners. Such foods, Chan added, also “often contain additives such as dyes, stabilizers and emulsifiers. Examples include most so-called ‘fast food,’ cookies and chips.” In light of other research indicating that diet influences depression risk, Chan and his colleagues specifically set out to see what impact processed foods might have on depression risk. They looked at nearly…  read on >  read on >

In a surprising move, the U.S. Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions. Approval of the Neffy nasal spray was widely anticipated. An FDA advisory panel voted to recommend approval of the drug for children and adults in May. While the FDA is not obligated to follow the advice of their advisory panels, it usually does. Instead, the FDA told the drug’s maker, ARS Pharmaceuticals, that it needed to conduct another study on the drug before it is approved, the company said in a statement late Tuesday night. “We are deeply disappointed that this action further delays the availability of Neffy for the millions of people who are at risk of a potentially life-threatening severe allergic reaction,” said Richard Lowenthal, co-founder, president and CEO of ARS Pharma. “We stand by the totality of the Neffy data package in a comprehensive registration program that was aligned upon with FDA and believe strongly in the value Neffy can provide for patients, families and caregivers living daily with severe allergic reactions,” he said in a company statement, adding that his firm will aim to complete the requested trial as soon as possible. The news was unwelcome on the front lines of health care. “It’s certainly disappointing as we were hoping to have…  read on >  read on >

Another diabetes drug maker is taking legal action against businesses in several states, alleging that they’re “fraudulently claiming” that their compounded products are the same as its medication. This time, it’s Eli Lilly suing certain medical spas, wellness centers and compounding pharmacies over its medication Mounjaro. Mounjaro contains the active ingredient tirzepatide and is approved by the U.S. Food and Drug Administration to treat type 2 diabetes. The lawsuits, filed Tuesday, are meant to stop the other companies from “the unlawful marketing and sale of non-FDA approved compounded products.” “Lilly filed this lawsuit to protect patients,” the company said in a statement issued Tuesday. “Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product.” The company sells Mounjaro only in prefilled single-dose pens. “These entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro,” the statement added. In June, Novo Nordisk sued businesses for making compounded versions of semaglutide, which is used in its type 2 diabetes drugs Ozempic and Rybelsus. The medication is also used to treat obesity under the brand name Wegovy. In its cases, Novo Nordisk has asked the companies “to cease and desist from false advertising, trademark infringement…  read on >  read on >

Before pouring another drink, consider this sobering new research: Heavy drinkers can develop fat around the heart, leading to heart failure and other cardiac problems. This so-called pericardial fat is associated with increased risk of heart disease. Researchers also linked heavy drinking to excess fat deposits around the liver and kidneys, which can result in diseases of these organs, too. “The accumulation of fats in these areas, especially at the heart, has been linked to higher risk of heart disease like heart failure, atrial fibrillation as well as coronary heart disease, which is the major killer of U.S. adults,” said lead researcher Dr. Richard Kazibwe, an assistant professor of internal medicine at Wake Forest University School of Medicine in Winston-Salem, N.C. Alcohol affects how the body handles fat, he said. “Drinking is a known risk for obesity. We know from the past that alcohol can influence metabolism. It can influence levels of hormones in the body that can lead to the distribution of fat in general, but also in various areas of the body,” Kazibwe said. That’s how fat ends up surrounding the heart, but if you stop imbibing will that fat disappear? Kazibwe said fat around the liver can be reduced if you stop drinking, but it isn’t known if the same is true for fat around the heart. The bottom line, in his…  read on >  read on >

Low-carb diets may be all the rage, but they’re not for kids with diabetes, according to the American Academy of Pediatrics (AAP). In a new report, the AAP says that low-carbohydrate diets cannot be recommended for children or teenagers with either type 1 or type 2 diabetes. That’s because there’s little evidence they’re helpful, but there are concerns about restricting kids’ diets to that degree. Instead, the AAP encourages families to focus on cutting out “bad” carbs: sugary drinks, sweets and other processed foods that are low in nutrients. Just as important, kids should get enough healthy carbs, including vegetables, beans and fiber-rich grains. The “keto” diet and similar ones popular among adults can put very strict limits on carbs, with a ceiling as low as 20 grams per day — equivalent to a half-cup of white rice. A big concern is that low-carb diets will shortchange kids on nutrients during critical periods of development, said Amy Reed, a pediatric dietitian with Cincinnati Children’s Hospital Medical Center. Reed, who was not involved in the AAP report, said she agrees with its recommendations. “The focus should be on healthy eating, rather than restriction,” said Reed, who is also a spokeswoman for the Academy of Nutrition and Dietetics. Diabetes exists in different forms: Type 1 diabetes arises from an immune system attack on the pancreatic cells that…  read on >  read on >

California is on track to become the first state to ban four food additives that some experts have linked to health issues ranging from behavioral problems in children to reproductive issues to cancer in lab animals. On Tuesday, the legislature passed Assembly Bill 418, which now awaits the signature of Gov. Gavin Newsom. The substances are permitted by the U.S. Food and Drug Administration, so this would be the first time a state has banned items allowed by federal regulators. The chemicals are already illegal in the European Union and other places around the world, NBC News reported. The ingredients are red dye No. 3, potassium bromate, brominated vegetable oil and propylparaben. The restriction would begin in 2027. “It’s going to make our food supply much safer,” Assembly member Jesse Gabriel, who introduced the bill along with Assembly member Buffy Wicks, told NBC News. “It’s going to give parents more confidence that when they’re buying foods at the grocery store, they don’t have to worry that there’s something in there that’s dangerous for their kids.” Although red dye No. 3 is banned in cosmetics because of its history of causing cancer in lab animals in high doses, it’s still allowed as a food coloring. Potassium bromate allows bread and baked goods to rise higher and improves texture. Brominated vegetable oil keeps flavoring from floating to…  read on >  read on >