While adult bed rails are marketed with safety in mind, they need to be used with caution, the U.S. Food and Drug Administration advises. “Many death and injury reports related to entrapment and falls for adult portable bed rail products and hospital bed rails have been reported to the FDA and the CPSC [U.S. Consumer Product Safety Commission],” the FDA said in a new webpage. Use bed rails with care, especially with older adults and people with altered mental status, physical limitations and certain medical conditions, the FDA advised. The FDA regulates bedrails that are sold for medical purposes. These might be used to help someone who is disabled, injured or recovering from surgery to transfer in and out of bed, and reduce the risk of falling or fracture. Those not marketed for medical purposes are instead considered consumer products and are under the jurisdiction of the CPSC. Sometimes these types of equipment are called side rails, bed side rails, half rails, safety rails, bed handles, bed canes, assist bars, grab bars, and adult portable bed rails. The FDA’s new webpage explains some of the risks associated with bed rails and offers some safety advice. Bed rails typically are divided into three distinct types, according to the FDA. There are portable bed rails for adults, portable bed rails used for children, and hospital bed rails…  read on >  read on >

In a tight vote, U.S. Food and Drug Administration advisors on Tuesday recommended the approval of an RSV vaccine that could be used in Americans ages 60 and up. The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. The same panel of advisors will weigh the potential approval of another respiratory syncytial virus (RSV) vaccine, this one from GlaxoSmithKline, on Wednesday. “In older adults, RSV can result in serious illness, hospitalization, or even death, so there is a significant need to protect this at-risk population,” Annaliesa Anderson, senior vice president and chief scientific officer for vaccine research and development at Pfizer, said in a news release announcing the panel decision. “We are encouraged by the outcome of today’s… meeting, as it is a testament to the strength of our science and dedication to bringing this important vaccine candidate to the market.” If the FDA follows the recommendation of its advisors, which it typically does, Pfizer’s vaccine would be the first shot to guard against RSV infection, NBC News reported. The U.S. Centers for Disease Control and Prevention would also need to recommend the single shot before it could become available to Americans. Still, the FDA advisors were divided in their recommendation. The panel voted 7-4, with one abstention, to recommend approval of the vaccine based on its efficacy, NBC News reported. FDA…  read on >  read on >

The U.S. Food and Drug Administration said Tuesday that it has taken action to restrict imports of the veterinary tranquilizer xylazine to prevent illicit use of the drug. While veterinarians use products containing xylazine to sedate large animals such as horses and deer, the drug is not safe for people. It is sold on the street under the names tranq, Philly dope and zombie drug. Federal officials say illicit drugs, including fentanyl and meth and cocaine, are often laced with xylazine. The drug has been detected in a growing number of overdose deaths. People who use illicit drugs may not be aware they contain xylazine, the FDA warned. “The FDA remains concerned about the increasing prevalence of xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address this issue,” FDA Commissioner Dr. Robert Califf said in an agency news release. “We will continue to use all tools at our disposal and partner with the Drug Enforcement Administration and other federal, state, local agencies and stakeholders as appropriate to stem these illicit activities and protect public health.” The FDA wants to ensure that imports of drugs containing xylazine are intended for legitimate veterinary use. That includes ingredients for processing at a facility that makes FDA-approved xylazine, compounding at licensed pharmacies and veterinary practices, as well as…  read on >  read on >

An artificial sweetener commonly used in processed foods could be increasing people’s risk of heart attack and stroke, a new study argues. Erythritol is a natural sugar alcohol found in many vegetables and fruit. Even the human body produces small amounts of erythritol. But higher levels of the sweetener added to processed foods might increase people’s risk of blood clots, researchers reported Feb. 27 in the journal Nature Medicine. People who had large amounts of erythritol in their blood were up to twice as likely to suffer a heart attack or stroke compared to those with the least amounts, the researchers found. “I think there’s plenty of data here to argue that we should be reading our labels and avoiding erythritol, particularly if you’re at risk for cardiovascular disease,” said senior researcher Dr. Stanley Hazen, chair of cardiovascular and metabolic sciences at the Cleveland Clinic’s Lerner Research Institute. But other experts expressed skepticism, saying more study is required before erythritol can be considered potentially harmful. “At this point, I think that using small amounts of this, whether it should be in some power bar that you eat or you use a granulated form to put it in your coffee or tea or to have occasionally on your oatmeal, I just don’t think it’s a worrisome thing at this point in time,” said Dr. Karen Aspry,…  read on >  read on >

Not all milks are created equally when it comes to nutrients. Reading the label can clue you in to what you’re getting out of the beverage, whether it be plant-based or dairy, according to the U.S. Food and Drug Administration. Nutritional content can vary between different plant-based products, the FDA said in a recent news release. Many don’t have the same amount of calcium, vitamin D or other nutrients as dairy milk. The only plant-based beverage that contains a similar enough nutrient content that it can be included in the dairy group in the federal government’s Dietary Guidelines for Americans is fortified soy milk. “The nutrients you get from plant-based milk alternatives can depend on which plant source is used, the processing methods and added ingredients, so check the label carefully,” said Susan Mayne, director of the Center for Food Safety and Applied Nutrition at the FDA. “Has the product been fortified with nutrients such as calcium? How much added sugar is in the product? What is the protein content?” “The Nutrition Facts label on the packaging can help you compare the nutrient content of the various plant-based milk alternatives to milk,” Mayne said. “The label can help you choose the best products to meet your nutrient needs and those of your family.” Plant-based milks can be made from grains, such as oat, quinoa and…  read on >  read on >

It may seem counterintuitive, but a new study review suggests that consuming too little salt could be harmful to heart failure patients. Doctors currently recommend a low-sodium diet to lower blood pressure and avoid fluid buildup and swelling, which can be common symptoms for heart failure. The condition develops when the heart muscle becomes too weak or stiff to effectively pump blood to the rest of the body. But the new meta-analysis of nine randomized, controlled trials found that restricting dietary sodium intake below the standard recommended maximum of about 2.3 grams per day did not bring additional benefits, and it also may increase the risk of death. The findings will be presented March 5 at the American College of Cardiology’s annual meeting, in New Orleans. “Our findings showed that restricting dietary sodium to less than the usual recommendation was counterproductive in the management of heart failure,” said study lead author Dr. Anirudh Palicherla, an internal medicine resident at Creighton University School of Medicine in Omaha, Neb. “Limiting sodium is still the way to go to help manage heart failure, but the amount of restriction has been up for debate,” Palicherla said in a meeting news release. “This study shows that the focus should be on establishing a safe level of sodium consumption, instead of overly restricting sodium.” While the average American eats about 3.4…  read on >  read on >

THURSDAY, Feb. 23, 2023 (HealthDay News) – Plant-based beverages that use oats, soy, almonds, cashews and other products instead of dairy can continue to call themselves milk. The U.S. Food and Drug Administration released new draft rules on Wednesday, and the agency will accept comments on the draft through April 23. These products don’t pretend to be from cows, the FDA guidance said, and American consumers aren’t confused by the “milk” name. Producers of these products, made from the liquid extracts of plants, will need to clearly label them with their plant source, calling them, for example, “soy milk.” The FDA is also asking for voluntary extra nutrition labels on the products if they have lower levels of the nutrients than dairy milk contains, including calcium, magnesium and vitamin D. While the National Milk Producers Federation, an industry trade group, approved of the decision asking for extra nutrition information, they rejected the FDA conclusion that the word milk is a “common and usual name,” the Associated Press reported. The Good Food Institute, an advocate for plant-based products, said “the guidance misguidedly admonishes companies to make a direct comparison” with cow’s milk, the AP reported. Key nutrients are already listed on labels of plant-based milk. Fortified soy milk is the only plant-based option that meets U.S. dietary guidelines for dairy. While plant-based milks do big business,…  read on >  read on >