The maker of the ADHD drug Vyvanse has been given approval by the U.S. Drug Enforcement Administration to make more of the medication as a shortage of the critical drugs continues. Following a request from the U.S. Food and Drug Administration in July, the DEA said Thursday that Takeda Pharmaceuticals may now increase its production limit by 24%. “These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine [Vyvanse] to meet legitimate patient needs both domestically and globally,” the DEA said in a notice it posted on the approval. ADHD drugs have been in short supply for years. The FDA first warned of a shortage of Teva Pharmaceutical Industries’ Adderall medication in October 2022, as the company was plagued by manufacturing delays. That prompted a spike in demand and subsequent shortage of Takeda’s Vyvanse. Why was the DEA’s approval to boost production needed? Vyvanse (lisdexamfetamine) is classified by the DEA as a schedule II controlled substance, which is applied to drugs considered to have a high likelihood of being abused, so additional prescribing safeguards are put in place. The production limit for lisdexamfetamine was increased by 13, 478 pounds (6,236 kilograms), which includes 3,434 pounds (1,558 kg) to address domestic demand and 10,313 pounds (4,678 kg) for foreign demand for finished dosage medications, according to the DEA. After Takeda lost exclusivity…  read on >  read on >

Thinking about quitting smoking? There are three top ways to help you stop, a new review finds. According to the study, folks wanting to quit should turn to: Varenicline, a prescription nicotine-blocking drug sold under the brand names Chantix and Champix Cytisine, a plant-based compound sold as an over-the-counter supplement in Canada and Europe Nicotine e-cigarettes “Quitting smoking is difficult, and some people find it harder to quit than others, but tobacco is uniquely deadly among legal consumer products, so it’s important to seek help quitting,” said lead investigator Jonathan Livingstone-Banks, a lecturer and researcher in evidence-based health care with the University of Oxford in the U.K. “There’s a range of effective forms of support for smoking cessation, and cytisine, varenicline and e-cigarettes are all evidence-based ways to greatly increase people’s chances of successfully quitting smoking,” Livingstone-Banks added. These strategies work best when combined with counseling or other behavioral support, researchers said. “For behavioral support, evidence is strongest for counseling and for programs that reward people for stopping smoking,” said senior researcher Jamie Hartmann-Boyce, an assistant professor of health policy and management with the University of Massachusetts Amherst School of Public Health and Health Sciences. Bupropion and nicotine replacement therapy are also effective, especially if nicotine patches are combined with fast-acting forms like gum, researchers said. The new study was published Sept. 4 in the…  read on >  read on >

A new brain imaging study has concluded that autism likely isn’t caused by faulty connections to the amygdala. A prevailing hypothesis of autism spectrum disorder has held that people with the condition have poorer neural connections in certain brain regions, including the amygdala. However, researchers found no evidence that people with autism had amygdala connections that differed substantially to those found in people without autism. The amygdala is a small, almond-shaped structure in the brain that plays a key role in processing emotions and social cues, researchers explained. For the study, researchers analyzed high-quality MRI brain scans from 488 people, including 212 with autism. The team focused on the neural connections emanating from the amygdala when the participants were not actively engaged in any tasks. Average variation in connectivity to the amygdala was similar in people with and without autism, results showed. The results were the same when researchers looked at specific subregions of the amygdala, researchers added. The new study was published in the American Journal of Psychiatry. “It is important to note that we do not conclude that amygdala [connectivity] is generally typical in autism. Instead, we conclude that the evidence for atypical [connectivity] of the amygdala in autism is weak at best, and unreliable,” concluded the researchers led by Dorit Kliemann, an assistant professor of psychological and brain sciences with the University…  read on >  read on >

The booming popularity of the weight-loss drug semaglutide has prompted increasing concerns about potential side effects from taking Ozempic or Wegovy. But a new study rules out one possible problem — using semaglutide does not increase a person’s risk of depression or suicide, researchers report. Semaglutide did not increase the risk of depression, suicidal thoughts or suicidal behavior in people without known mental health disorders, according to an analysis of data from clinical trials that led to approval of the drug. The new study reviewed data from more than 3,500 people across four major clinical trials for semaglutide. The trials were funded by Novo Nordisk, the maker of Ozempic and Wegovy. About 1% or fewer of the clinical trial participants reported suicidal thoughts or behaviors, with no differences between those taking semaglutide or a placebo, researchers reported Sept. 3 in the journal JAMA Internal Medicine. What’s more, 2.8% of those taking semaglutide developed depressive symptoms, compared with 4.1% of those taking a placebo. “It is certainly possible that individuals with overweight or obesity who take semaglutide may experience depressive symptoms or suicidal ideation or behavior, but the data suggest that persons not taking semaglutide — in the placebo group in this study — are equally likely to experience these conditions,” said researcher Gregory Brown, director of the Penn Center for the Prevention of Suicide at…  read on >  read on >

Folks taking weight-loss drugs like Wegovy or Zepbound might think they’ve found a shortcut to better health. But they still need to eat a high-quality diet if they want to maintain their well-being while they shed pounds, says a doctor with the University of Texas Southwestern. “One common misconception about these medications is that they’re a magic bullet for better health, and it doesn’t necessarily matter what you eat when you’re taking them. Nothing could be further from the truth,” said Dr. Jaime Almondoz, director of UT Southwestern’s Weight Wellness Center. The typical American diet contains loads of ultra-processed, calorie-dense foods, but is often deficient in fruits, vegetables, fiber and essential nutrients, Almondoz said. People on weight-loss drugs could suffer loss of muscle mass, fatigue, malnutrition and other health consequences if they don’t eat healthy, Almondoz said. Folks preparing for bariatric surgery are required to have multiple visits with a registered dietitian to create a healthy eating plan for them going forward. “No such guidelines exist yet for anti-obesity medications, though patients now lose similar amounts of weight with these medications as they do with bariatric surgery,” Almondoz said in a UT Southwestern news release. A few basic steps can reduce the risk of GI side effects while taking weight loss drugs, Almondoz said. These include: Avoiding fried and high-fat foods Limiting intake of carbonated drinks,…  read on >  read on >

FRIDAY, Aug.30, 2024New trials are showing how the blockbuster diabetes and weight-loss meds Ozempic and Wegovy can boost health in even more ways. These two injected drugs are versions of semaglutide. In multiple new data analyses, the drugs appeared to cut people’s odds for heart failure and its complications, reduce deaths from COVID-19 and lower deaths from any cause. Semaglutide is a member of family of drugs called GLP-1 agonists, which work by mimicking the effect of a natural hormone that helps reduce appetite, hunger and food intake.  The latest findings were presented Thursday in London at the annual meeting of the European Society of Cardiology (ESC) and published simultaneously in the Journal of the American College of Cardiology (JACC). The data show that “these groundbreaking medications are poised to revolutionize cardiovascular care and could dramatically enhance cardiovascular health,” said Dr. Harlan Krumholz, JACC Editor-in-Chief and a professor of medicine at Yale University. Some of the findings derive from sub-analyses of data from a major trial called SELECT, which included more than 17,000 people who were overweight or obese and had been diagnosed with heart disease, but not diabetes. The trial was funded by semaglutide’s maker, Novo Nordisk, and in findings published in November it found that the 2.4 milligram (mg) dose of the drug cut the odds of heart-related deaths, heart attacks and strokes. In…  read on >  read on >

Fluorescent light can be used to highlight bacteria that hides in wounds, causing infections and slowing down the healing process, a new evidence review says. A handheld fluorescent device can light up bacteria in 9 out of 10 wounds that traditional clinical treatment would overlook, according to a study in the journal Advances in Wound Care. “We’re hopeful this new technology can help surgeons improve their accuracy when pinpointing and consequently removing bacteria from wounds and therefore improve patient outcomes, particularly for those with diabetic foot wounds,” said senior researcher Dr. David Armstrong, a podiatric surgeon and limb preservation specialist with the University of Southern California. “The early detection and removal of bacteria from a wound is vital to preventing avoidable amputations,” he added in a university news release. More than 6.5 million Americans experience chronic wounds that don’t heal within a few months, researchers said in background notes. Nearly all such wounds contain bacteria, and if not detected and removed, these germs can cause a severe infection that might end in amputation or death. Doctors cleaning out a wound do their best to remove as much bacteria as possible, but these bugs can’t be seen by the human eye and can be missed, researchers said. That’s why the research team decided to investigate autofluorescence imaging, in which violet light is used to illuminate bacteria.…  read on >  read on >

More than half of people around the world aren’t getting enough micronutrients essential to human health, including calcium, iron and vitamins C and E, a new study says. These deficiencies are contributing to global malnutrition, as well as health problems like blindness, increased vulnerability to infections, and pregnancy complications, researchers said in The Lancet Global Health. “These results are alarming,” researcher Ty Beal, a senior technical specialist at the Global Alliance for Improved Nutrition, said in a news release. “Most people — even more than previously thought, across all regions and countries of all incomes — are not consuming enough of multiple essential micronutrients,” Beal said. “These gaps compromise health outcomes and limit human potential on a global scale.” For the study, researchers combined data from several sources to compare the nutritional intake of people in 185 countries. The team specifically assessed intake of 15 vitamins and minerals — calcium, iodine, iron, riboflavin, folate, zinc, magnesium, selenium, thiamin, niacin, and vitamins A, B6, B12, C and E. Researchers found widespread inadequate intake of iodine (68% of the world’s population); vitamin E (67%); calcium (66%); and iron (65%). More than half of people consume inadequate levels of riboflavin, folate, and vitamins C and B6, researchers added. Intake of niacin was closest to sufficient, with 22% of people worldwide consuming too little, followed by thiamin (30%) and…  read on >  read on >

Breastfeeding helps women shed those extra pounds of “pregnancy weight,” a new study finds, and the effect is even more pronounced for moms who were overweight before their pregnancy. Among women who exclusively breastfed their baby during its first year, women who were normal weight prior to pregnancy lost weight, but still retained about three extra pounds of their pregnancy weight, reported a team of researchers in Singapore. However, breastfeeding new moms who were already obese or overweight before their pregnancy lost all their added pregnancy weight, plus an average of another half-pound on top of that, the same team found. Women who chose not to breastfeed or had a mix of formula plus breastfeeding retained much more pregnancy weight, with average weight gains at 12 months post-delivery of about 6 and 8 pounds, respectively. “In this year-long study, we made an interesting discovery — an additional benefit [of breastfeeding] for women with high BMI,” said study lead author Dr. Loy See Ling, of the department of reproductive medicine at KK Women’s and Children’s Hospital in Singapore. “Due to hormonal factors, there is a re-distribution and management of their body fat to the extent that there is an opportunity for them to lose more than the postnatal weight gain,” Ling explained in a hospital news release. Her team published its findings recently in the journal Nutrients.…  read on >  read on >

Jillian Davis was pleased to be gifted a car seat during her pregnancy, from a family member who bought it online from a major retailer. But following the delivery of her daughter in late June, a car seat tech at her Salt Lake City hospital informed her that the seat was an unsafe counterfeit. “It’s completely shocking because this is my fourth child and I’ve never heard of this being an issue,” Davis said in a hospital news release. “It’s scary to think I could have been driving around with my child in a car seat that’s dangerous.” Online retailers are selling fake kid’s car seats that are very likely to fail in a crash, child health experts warn. These seats are enticing because they cost much less than major brands, and are sold on prominent national retail websites through third-party sellers, experts said. “It’s hard to tell a car seat is counterfeit from a small picture online, and many parents think they found a great deal from a major retailer,” said Michelle Jamison, community health program manager at Intermountain Primary Children’s Hospital in Salt Lake City. “Once they realize there’s a problem and try to return it, the site they got it from has already been taken down,” Jamison added in a hospital news release. Intermountain Children’s offers car seat checks to help parents…  read on >  read on >