More than a year after its advisory panel unanimously declared the drug phenylephrine to be useless against nasal congestion, the U.S. Food and Drug Administration is proposing that it be removed from common over-the-counter decongestants. Products that include phenylephrine as an active ingredient include Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion. In fact, “it is important to note that some products only contain oral phenylephrine as a single, active ingredient,” the FDA said in a statement released Thursday. However, based on the available science, it’s time for consumers to stop throwing their money away on such products, the FDA said. “It is the FDA’s role to ensure that drugs are safe and effective,” Dr. Patrizia Cavazzoni, who directs the FDA’s Center for Drug Evaluation and Research (CDER), said in the statement. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.” The agency said its experts poured over decades of data on whether or not phenylephrine could ease nasal congestion. They found no evidence to support the claim, nor any evidence to support the notion that phenylephrine might boost the effects of other medicines included in a decongestant, such as acetaminophen or dextromethorphan. At…  read on >  read on >

The head of the company that makes the diabetes and obesity drugs Ozempic and Wegovy has warned that compounded versions of the active ingredient in those medications have now been linked to at least 100 hospitalizations and 10 deaths. “Honestly, I’m quite alarmed by what we see in the U.S. now,” Novo Nordisk President and CEO Lars Fruergaard Jorgensen told CNN on Wednesday. “Patients who believe that they’re getting access to a safe product, and they believe they’re getting semaglutide … I know for a fact that they are not getting semaglutide, because there’s only one semaglutide, and that’s produced by Novo Nordisk, and we don’t sell that to others.” Compounded drugs are made by pharmacies or manufacturers other than the companies that make approved versions of those medicines, and they typically are allowed when there is a shortage of those drugs. Semaglutide, and other GLP-1 drugs like it, have experienced shortages in the past two years as millions of Americans have turned to the medications for help with significant weight loss. While semaglutide remains on the shortage list, Novo Nordisk noted last week that the last remaining dose in short supply — the lowest dose of Wegovy — is now listed as available, CNN reported. “We’re collaborating with the FDA, and I think they’re looking into what are some of the considerations they have…  read on >  read on >

THURSDAY, Nov.7, 2024Women who take vitamin D supplements during a pregnancy may be giving their kids the legacy of stronger bones, new British research suggests. Children whose moms took vitamin D supplements when pregnant had stronger, denser bones at the age of 7 compared to the kids of women who didn’t, a study from the University of Southampton shows. It’s an head start on bone health that might last a lifetime, said lead researcher Dr. Rebecca Moon. “This early intervention represents an important public health strategy. It strengthens children’s bones and reduces the risk of conditions like osteoporosis and fractures in later life,” said Moon, a clinical lecturer in child health at the university. Her team published its findings in the November issue of The American Journal of Clinical Nutrition. It’s long been understood that vitamin D — often called the “sunshine vitamin” because human skin manufactures it upon contact with sunlight — plays a key role in bone development and health. As the British team explained, the nutrient regulates the body’s levels of calcium and phosphate — two minerals needed for strong bones, teeth and muscle health. Could maintaining good levels of vitamin D in pregnancy benefit offspring? To find out, Moon’s team randomized over 1,000 pregnant women into two groups. Half got an extra 1,000 International Units per day of vitamin D in supplement…  read on >  read on >

Seniors who are drowsy during the day and find it hard to muster enthusiasm for activities could be at higher risk of a brain condition that precedes dementia, a new study warns. These sleep-related problems are associated with “motoric cognitive risk syndrome,” a pre-dementia condition that causes slow walking speed and some memory problems, researchers explained. People with excessive daytime sleepiness and a lack of enthusiasm are more than three times more likely to develop this syndrome, compared to people without those sleep-related problems, researchers reported Nov. 6 in the journal Neurology. “More research needs to be done to look at the relationship between sleep issues and cognitive decline and the role played by motoric cognitive risk syndrome,” said researcher Dr. Victoire Leroy, with the Albert Einstein College of Medicine in New York City. “We also need studies to explain the mechanisms that link these sleep disturbances to motoric cognitive risk syndrome and cognitive decline.” For the study, researchers recruited 445 people, average age 76, without dementia. These seniors filled out questionnaires about sleep habits and memory issues, and their walking speed was repeatedly tested on a treadmill. About 177 people met the definition for poor sleepers, and 268 met the definition for good sleepers. At the start of the study, 42 people had motoric cognitive risk syndrome. During the average three-year follow-up, another 36…  read on >  read on >

In 1972, Britain bumped up the total school years mandated for its children from 15 to 16 years. That created a “natural experiment”: Would Britons who got that extra year of education fare any better, neurologically, as they aged? Unfortunately, the answer is “no.” “This surprised us,” said study co-author and brain researcher Nicholas Judd, from Radboud University Medical Center (Radboudumc) in Nijmegen, The Netherlands. “We know that education is beneficial, and we had expected education to provide protection against brain aging,” he said in a medical center news release. “Aging shows up in all of our MRI measures, for instance we see a decline in total volume, surface area, cortical thickness and worse water diffusion in the brain. However, the extra year of education appears to have no effect here.” The findings were published Nov. 5 in the journal eLife. Judd and Radboudumc co-researcher Rogier Kievit accessed the MRI brain scans of more than 30,000 adult Britons taken an average of 46 years after they attended school in the early 1970s. Education has long been associated with brain resiliency, so it was assumed that the brains of people who went to school that extra year might differ in subtle ways from those who graduated before the new law was enacted. But Judd and Kievit saw no differences in various aspects of brain structure that they…  read on >  read on >

Folks are more likely to drive drowsy than drive drunk, even though both raise the risk of a fatal crash, a new survey shows. About 4 in 10 adults say they’ll find alternative transportation when they haven’t gotten enough sleep, according to the poll from the National Sleep Foundation (NSF). By comparison, nearly 7 in 10 adults say they won’t drive after having a few drinks. Drowsy driving is a significant threat to road safety, just like drunk, drugged or distracted driving can be, according to the NSF. “NSF data consistently show that Americans do not think drowsy driving is as dangerous as other forms of impaired driving, like drunk driving,” said Joseph Dzierzewski, senior vice president of research and scientific affairs for the NSF. “We want the public to know that sleeping only three to four hours before driving is like having a few drinks, and encourage everyone to have a backup plan in place for when they are not alert enough to drive safely, like choosing ride share or taxi options, or calling friends and family to help you and others stay safe,” Dzierzewski said in an NSF news release. Drowsy Driving Prevention Week runs from Nov. 3-9, and the new NSF survey was fielded as part of that observance.  Drowsy driving is responsible for 1 in every 5 deadly motor vehicle crashes,…  read on >  read on >

Poorer folks’ access to blockbuster weight-loss drugs through Medicaid remains limited, a new KFF analysis has found. Only 13 states currently allow Medicaid to cover treatment of obesity using glucagon-like peptide-1 agonist (GLP-1) medications, researchers discovered. Under the Medicaid system, individual states are allowed to decide whether to cover GLP-1 drugs, which include Wegovy (semaglutide), Zepbound (tirzepatide) and Saxenda (liraglutide), the KFF report noted. Among those states that don’t cover the drugs, half reported that they are considering adding coverage in the near future, the researchers added. But GLP-1 drugs are pricey, and nearly two-thirds of states said cost is a hurdle to approving coverage of the meds through Medicaid. “Expanding Medicaid coverage of these drugs could increase access for the almost 40% of adults and 26% of children with obesity in Medicaid,” wrote the research team led by senior investigator Clea Bell, a research assistant in state health reform for KFF. “At the same time, expanded coverage could also increase Medicaid drug spending and put pressure on overall state budgets.” Glucagon-like peptide-1 (GLP-1) drugs mimic the GLP-1 hormone, which helps control insulin and blood sugar levels, decreases appetite and slows digestion of food. However, the drugs are costly — people without insurance face paying more than $1,000 a month to take them. The 13 states where Medicaid covers GLP-1 drugs for obesity are California,…  read on >  read on >

Current treatments sometimes fail to help people with “wet” age-related macular degeneration — and researchers now think they know why. Wet AMD is caused by an overgrowth of blood vessels in the retina, the light-sensing tissue at the back of the eye. The vessels leak fluid or bleed, damaging the retina and causing vision loss. To combat this, doctors prescribe medications that slow the growth of new blood vessels, called anti-VEGF (vascular endothelial growth factor) drugs. Unfortunately, these anti-VEGF drugs might actually hamper vision improvements by triggering the over-expression of a second blood-vessel-related protein, researchers have discovered. This second protein, ANGPTL4, also can stimulate overproduction of abnormal blood vessels in the retina, researchers reported Nov. 4 in the Proceedings of the National Academy of Sciences. These findings could explain why fewer than half of patients who receive monthly anti-VEGF eye injections wind up showing any major improvements in their vision, researchers said. “We have previously reported that ANGPTL4 was increased in patients who did not respond well to anti-VEGF treatment,” said researcher Dr. Akrit Sodhi, an associate professor of ophthalmology at the Johns Hopkins University School of Medicine, in Baltimore. “What we saw in this paper was a paradoxical increase of ANGPTL4 in patients that received anti-VEGF injections — the anti-VEGF therapy itself turned on expression of this protein,” Sodhi said in a Hopkins news…  read on >  read on >

Banning menthol cigarettes could help convince smokers quit the habit, a new study finds. People who prefer menthol cigarettes would rather buy nicotine gum or other nicotine replacement therapies than switch to traditional tobacco cigarettes, researchers reported recently in the journal Drug and Alcohol Dependence. In addition, menthol cigarette smokers were less likely to use e-cigarettes as a substitute if menthol vaping products are also restricted, researchers found. “I think the most important conclusion from this study is that we can improve health outcomes by emphasizing policies that reduce sales of flavored products and increase accessibility of nicotine replacement therapies,” said researcher Roberta Freitas-Lemos, an assistant professor at the Virginia Tech Fralin Biomedical Research Institute. More than 9 million adults — about 32% of all smokers — use menthol cigarettes, researchers said in background notes. Menthol makes smoking easier by reducing the harshness of cigarette smoke and cooling the throat.  The Biden Administration has come under fire for delaying a proposed U.S. Food and Drug Administration ban on menthol cigarettes. In a September hearing before Congress, FDA leaders said a menthol ban is still in the works. “It’s a priority for us. We followed through rule-making processes and it’s presently with the White House and it continues to be a priority for us,” Brian King, director of the FDA’s Center for Tobacco Products, told a…  read on >  read on >

Many people turn to mindfulness meditation to help them manage their chronic pain, a practice that’s been used for centuries. However, it’s been an open question whether meditation is simply functioning as a placebo, rather than actually quelling pain. Now, a new study involving brain scans has revealed that’s not the case. Mindfulness meditation engages distinct brain mechanisms to reduce pain, and those are not part of a placebo response, researchers reported. “These two brain responses are completely distinct, which supports the use of mindfulness meditation as a direct intervention for chronic pain rather than as a way to engage the placebo effect,” said lead researcher Fadel Zeidan, a professor of anesthesiology with the University of California, San Diego. For the study, researchers recruited 115 healthy people and randomly placed them into four different treatment groups: An actual mindfulness meditation practice that involved focusing on breath without judgment A sham meditation practice that only consisted of deep breathing A placebo cream that patients were trained to believe reduce pain A control group that listened to an audiobook The team then applied a very painful but harmless heat stimulus to the back of every person’s leg and scanned their brains, to see how each responded to the pain. Placebo cream and the sham medication practice both lowered pain, but mindfulness meditation was significantly more effective at…  read on >  read on >