The U.S. Food and Drug Administration (FDA) has approved the first prescription medication specifically for treating obstructive sleep apnea (OSA): the weight-loss drug Zepbound. In a news release published Dec. 20, the FDA stated that Zepbound, part of the GLP-1 receptor agonist medicines that include Ozempic, was cleared to treat moderate to severe OSA in individuals with obesity. According to drugmaker Eli Lilly, the treatment is intended for use alongside a reduced-calorie diet and increased physical activity. “Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” Dr. Sally Seymour, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a news release. “This is a major step forward for patients with obstructive sleep apnea.” OSA, a condition affecting as many as 30 million Americans, is characterized by breathing disruptions during sleep caused by blocked airflow. Weight loss has long been recognized as an effective strategy to reduce OSA severity. “Many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” Patrik Jonsson, president of Lilly Cardiometabolic Health, said in a news release from the company. In clinical trials, he noted, nearly half of Zepbound users saw such significant improvements that their OSA symptoms resolved. FDA approval for Zepbound in treating sleep apnea was… read on > read on >
All Eats:
Check Your Pantry, Lay’s Classic Potato Chips Recalled Due to Milk Allergy Risk
FRIDAY, Dec. 20, 2024 (HealthDay News) — Holy chip! Frito-Lay has issued a limited recall of select 13-oz bags of Lay’s Classic Potato Chips due to the potential presence of undeclared milk, which could pose a serious health risk to individuals with a milk allergy. According to a report released by the U.S. Food and Drug Administration (FDA), the affected bags have a “guaranteed fresh” date of Feb. 11, 2025, and the manufacturing codes 6462307xx or 6463307xx. These chips were distributed in Oregon and Washington through retail stores and online distributors, a media report shows. Consumers may have purchased them starting in early November. The report also shows that Frito-Lay clarified that no other Lay’s products or sizes are impacted by the recall. While no illnesses or adverse reactions have been reported so far, individuals with allergies or severe sensitivities to milk are advised to avoid consuming the chips and discard them immediately. Questions? Call Frito-Lay: 800-352-4477. More information More details about food recalls are available on the FDA’s official website. SOURCE: U.S. Food and Drug Administration, news release, Dec. 18, 2024; CNN read on >
FDA Updates Meaning of ‘Healthy’ on Food Labels
THURSDAY, Dec. 19, 2024 (HeathDay News) — The U.S. Food and Drug Administration wants to redefine the meaning of healthy food, issuing a new rule Thursday that changes the way food companies can claim their products are indeed nutritious. What foods will qualify for the new designation? Under the final rule, pretty much everything in the produce section — whole fruits and vegetables — would be considered healthy, as would other nutrient-rich foods like whole grains, dairy, eggs, beans, lentils, seafood, lean meat, nuts and seeds. “It’s critical for the future of our country that food be a vehicle for wellness. Improving access to nutrition information is an important public health effort the FDA can undertake to help people build healthy eating patterns,” FDA Commissioner Dr. Robert Califf, said in an agency news release announcing the new rule. “It is vital that we focus on the key drivers to combat chronic disease, like healthy eating.” “Now, people will be able to look for the ‘healthy’ claim to help them find foundational, nutritious foods for themselves and their families,” he added. The idea is to simplify things for shoppers who are confused by nutrition fact labels that don’t give any real-world guidance on whether one product is better than another, the agency added. Nutrition experts welcomed the change. “It’s a terrific advance,” Dr. Dariush Mozaffarian, director of… read on > read on >
Milk Cereal Drinks for Infants May Trigger Weight Gain
Adding cereal to a baby’s bottle is a habit that’s been around for a long time to help introduce solid foods while also supplementing a mom’s breast milk. But this practice can cause babies to pack on some pounds early in life, however, a new study says. Infants were about 50% more likely to experience rapid weight gain if they were fed milk cereal drinks during their first year, according to results published Dec. 18 in the journal Acta Paediatrica. “Milk cereal drinks were associated with early rapid weight gain,” concluded the research team led by Annelie Lindholm, a lecturer with the Halmstad University School of Health and Welfare in Sweden. However, milk cereal drinks didn’t necessarily translate into childhood obesity. Milk cereal drinks on their own were not associated with higher BMI or waist-to-height ratio by the time a child was 6, results show. But overall early rapid weight gain was associated with childhood obesity, doubling a child’s risk of high BMI by age 6, results showed. More research is needed to tease out the risks of both milk cereal drinks and rapid infant weight gain, researchers said. “Despite the cross-sectional associations between early rapid weight gain and milk cereal drink consumption, this study could not demonstrate a long-term detrimental association between milk cereal drinks and adiposity later in childhood,” researchers concluded. ”Early rapid… read on > read on >
FDA: Veozah, First Hormone-Free Hot Flash Drug, Issued Black Box Warning
The U.S. Food and Drug Administration (FDA) has issued its most serious warning — a black-box warning — for Veozah, a medication used to relieve hot flashes in menopausal women, due to rare but potentially severe liver risks. In new communication issued Dec. 17, the FDA advised that women taking Veozah should undergo regular blood testing to monitor liver health. Warning signs of liver injury can include fatigue, nausea, vomiting, dark urine, light-colored stool, or yellowing of the skin or eyes, a news release says. Patients experiencing these symptoms should immediately stop taking the medication and consult with their doctor. “It’s important to note that the overall benefit-risk of Veozah has not changed and remains positive, but we want to further ensure that patients and healthcare providers are aware of the potential side effects,” as well as recommended lab testing, Astellas Pharma, the manufacturer of the drug, said in a statement. Veozah was approved in 2023. At the time, it was the first non-hormonal prescription option for treating hot flashes. The medication works by blocking neurokinin B, a receptor involved in the brain’s regulation of body temperature. Since its approval, the drug’s popularity has grown steadily, with nearly 29,000 prescriptions filled in May 2024 alone, according to FDA data. The FDA’s heightened warning comes after reviewing a recent case where a patient developed elevated liver… read on > read on >
Artificial Sweetener Use Tied to Less-Healthy Diets
Folks who switch to artificial sweeteners in drinks and food may be drawn to other types of unhealthy fare — bringing down the quality of their overall diet, new research suggests. The study, published recently in the American Journal of Clinical Nutrition, tracked the diets of almost 164,000 people averaging 53 years of age, about four-fifths of who were women. All were enrolled in an ongoing American Cancer Society (ACS) study aimed at cancer prevention. Levels of folks’ intake of artificial sweeteners — in packets, beverages and yogurt — was tracked along with a host of other foods. The qualty of people’s overall diet was assessed using the ACS Diet Score. The research showed that as levels of artificial sweeteners rose, the overall quality of folks’ diets declined. For example, increased artificial sweetener intake was linked to a lower consumption of fruits and vegetables, the study found, but more processed foods. Why might that be so? Although the sweeteners are “used to replace added sugar, our study demonstrates consumers of food and beverages with sugar substitutes are also consuming other foods and beverages that are high in nutrients of concern, such as saturated fats, sodium and added sugar,” said study lead author Allison Sylvetsky. She’s an associate professor of exercise and nutrition sciences at George Washington University in Washington, D.C. In fact, at the highest… read on > read on >