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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 >

An experimental three-in-one blood pressure pill works better than layering on meds one at a time, a new clinical trial shows. After a month on the combo pill, 81% of patients had their blood pressure under control compared with 55% of patients receiving standard care, researchers report. “The triple pill still produced clinically meaningful reductions in blood pressure compared to standard care, even when standard care closely followed current guidelines and involved more clinic visits,” said lead investigator Dr. Dike Ojji, head of the Cardiovascular Research Unit at the University of Abuja in Nigeria. “In low-income countries, fewer than one in four treated people achieve blood pressure control, and in high-income settings it is only between 50% and 70%, so to see rates of over 80% in just one month is impressive,” Ojji added. The GMRx2 pill, which was developed by the pharmaceutical company George Medicines, contains the blood pressure meds telmisartan, amlodipine and indapamide. It’s taken once daily. The company is part of the George Institute for Global Health. Researchers compared people taking the combo pill to those receiving standard treatment for high blood pressure, which involves starting off with one drug and then adding on others. Systolic blood pressure was 31 points lower in the combo pill group after six months of treatment, compared to 26 points lower with standard care, results showed.… read on > read on >

Your cellphone might be harming your heart, a new study warns. People who regularly use a cellphone have a higher risk of heart disease, researchers found in a large-scale study. And the more time someone spends on their phone, the greater their risk for heart problems, researchers report. Risk of heart disease was about 21% higher in people who use their phone six hours or more a week, compared with 15% higher for those on the phone four to six hours and 13% for one to three hours, results show. “We found that compared with non-regular mobile phone users, regular mobile phone users had a significantly higher risk of incident cardiovascular diseases,” said researcher Dr. Ziliang Ye, with Southern Medical University in China. For the study, researchers analyzed data from more than 444,000 participants in the long-term UK Biobank research project. The participants all reported the frequency of their cellphone use. Researchers defined regular mobile phone use as at least one call per week. The research team tracked the participants for about 12 years, looking to see if they’d been diagnosed with stroke, heart disease, heart rhythm problems or heart failure. It turned out that regular phone users did have a higher risk of heart problems, compared to non-users, and that more cellphone use increased that risk. Cellphone use can impact a person’s sleep patterns… read on > read on >

A new, tougher rule on the sale of tobacco products will require retailers to check the IDs of any buyers under the age of 30, the U.S. Food and Drug Administration announced Thursday. The final rule, which will go into effect Sept. 30, also restricts tobacco vending machine sales to spaces that are limited to people aged 21 and older. “Today’s rule is another key step towards protecting our nation’s youth from the health risks of tobacco products,” Dr. Brian King, head of the FDA’s Center for Tobacco Products, said in an agency news release on the rule. “Decades of science has shown that keeping tobacco products away from youth is critical to reducing the number of people who ultimately become addicted to these products and suffer from tobacco-related disease and death.” Importantly, the new restrictions also apply to e-cigarettes, which are popular among young smokers. Although the number of children using e-cigarettes has started to decline over the past five years, 1 out of 10 high schoolers still say they vaped in the previous 30 days. For middle schoolers, that number was 1 in 22, according to the U.S. Centers for Disease Control and Prevention. Studies also show that 9 out of 10 adults who smoke daily reported having their first cigarette by age 18, CNN reported. The federal age limit for tobacco purchases was 18 until… read on > read on >

“Stealth” foods are sneaking saturated fat and added sugars into even the strictest diets, a new study shows. Most saturated fats and added sugars come from well-known sources – soft drinks, cheese, pizza, ice cream, cakes and pies. But even supposedly healthy foods like chicken breast and seafood or condiments like salad dressings and ketchup contain hidden amounts of saturated fats and sugars, researchers reported recently in the journal Nutrients. Such popular and generally healthy sources make it difficult for people to limit fat and sugar to the recommended 10% of daily calories, researchers said. “Chicken breast is promoted as a lower saturated fat food, but it still has a little bit of saturated fat,” said lead researcher Christopher Taylor, director of medical dietetics at Ohio State University. “It is helpful to know how foods with smaller amounts also slowly add saturated fat in a stealthy way into the diet.” “Being able to meet less than 10% is to identify the big contributors, but also to be able to see where saturated fat and added sugar may still exist in other food choices,” Taylor added. “It doesn’t make them poor choices – it’s about being aware of how the morning latte may be contributing.” For the study, researchers analyzed data on more than 36,000 U.S. adults who participated in a federal nutrition survey between 2005… read on > read on >

Emboldened by success in its initial efforts to cut dietary salt intake by Americans, the U.S. Food and Drug Administration on Thursday announced Phase II of the endeavor. U.S. Dietary Guidelines recommend that a person consume no more than 2,300 milligrams (mg) of sodium per day, the equivalent of about one teaspoon of salt. Excess salt intake is a strong risk factor for high blood pressure, heart disease and stroke. However, Americans typically take in far higher amounts than recommended, averaging about 3,400 mg/day before 2021, the FDA noted in a news release. Phase 1 of the FDA’s voluntary sodium-reduction targets for the food industry were issued in 2021, and according to the agency “preliminary data from 2022 show about 40% of the initial Phase I targets are very close to or have already been reached, indicating early success of this effort.” That level of success has spurred the agency to begin Phase II. “If finalized, the new set of voluntary targets would support reducing average individual sodium intake to about 2,750 milligrams per day,” the FDA said. The new initiative is expected to coincide with the U.S. Department of Agriculture’s efforts to limit sodium in school meals. “Reducing sodium in the food supply has the potential to be one of the most important public health initiatives in a generation,” Jim Jones, FDA Deputy Commissioner… read on > read on >

Chugging coffee, swilling colas or pounding down energy drinks could cause heart damage over time, a new study warns. All of these drinks contain caffeine, and a new study finds that folks who drink more than 400 milligrams of caffeine a day appear more likely to develop heart disease. The research was reported Thursday at the American College of Cardiology’s Asia scientific meeting in Delhi, India. The amount of daily caffeine cited in the study is the equivalent of four cups of coffee, 10 cans of soda or two energy drinks, researchers said. Consuming that much caffeine daily significantly raised heart rate and blood pressure over time, researchers found. Those who drank the highest amounts — 600 milligrams a day — had significantly elevated heart rate and blood pressure even after five minutes of rest following a three-minute step test. “Due to its effect on the autonomic nervous system, regular caffeine consumption could put otherwise healthy individuals at risk of hypertension and other cardiovascular events,” said lead researcher Dr. Nency Kagathara with Zydus Medical College and Hospital in Dahod, India. “Increasing awareness of these risks is vital to improve heart health for all.” For the study, researchers recruited 92 healthy people between the ages of 18 and 45. All participants were quizzed about their caffeine intake and underwent a three-minute step test to check their… read on > read on >

Untreated high blood pressure in your 60s could raise your risk for Alzheimer’s disease later, new research shows. The good news: Simple steps can ease hypertension, researchers said. The global study found that “taking blood pressure medications was associated with decreased risk of Alzheimer’s disease throughout later life,” said study lead author Dr. Matthew Lennon, of the University of New South Wales in Australia. “These results suggest that treating high blood pressure as a person ages continues to be a crucial factor in reducing their risk of Alzheimer’s disease.” The findings were published Aug. 14 in the journal Neurology. As Lennon explained in a journal news release, “taking blood pressure medications has also been found in previous research to reduce a person’s risk of dementias overall, but less is known about how blood pressure affects a person’s risk of Alzheimer’s disease.” Trying to answer that question, his team conducted a “meta-analysis” of data on more than 31,000 people who had been in 14 studies that measured cognitive change and dementia diagnosis over time. Participants came from the United States, but also from a large number of diverse nationalities around the world. A total of 1,415 cases of Alzheimer’s disease were diagnosed among the group over an average follow-up of four years. Overall, 9% of participants were found to have untreated high blood pressure, the… read on > read on >

A study of more than 400,000 people tracked for up to 24 years finds that those who got their dietary fat from plants versus animals had significantly lower odds of dying during the study period. Plant-based fats’ benefit included a reduced odds for deaths due to heart disease, the research showed. Conversely, the study “provides evidence that diets high in animal-based fats, including dairy and eggs, are associated with elevated risks of overall and cardiovascular disease mortality,” concluded a team led by Dr. Demetrius Albanes, of the U.S. National Cancer Institute. As the researchers noted, the composition of fats found in plant sources — grains, vegetables, beans or nuts — differs greatly from that sourced from animals. “Plant-based fats are recognized for their greater composition of monounsaturated fatty acids [MUFAs] and polyunsaturated fatty acids [PUFAs], whereas animal-based fats are characterized by a higher proportion of saturated fatty acids [SFAs],” the team explained. Bodies need fat to live, but U.S. dietary guidelines say that cutting down on saturated fats and replacing them with unsaturated fats is a healthy move. How much would that help folks over the long term? To find out, Albanes’ team looked at dietary and health data collected from 1995 through 2019 as part of the National Institutes of Health AARP Diet and Health Study. The analysis included data on 407,531 adults who… read on > read on >

Advocates for the use of the psychedelic drug MDMA (midomafetamine) to treat mental health conditions were delivered a setback on Friday after the U.S. Food and Drug Administration declined to approve it as treatment for post-traumatic stress disorder (PTSD). There is insufficient evidence that MDMA — currently illegal and also known as Ecstasy or molly — can ease PTSD, the agency told Lykos Therapeutics, a company that’s been seeking to gain approval for the drug’s legitimate use. The FDA asked that Lykos conduct another clinical trial to determine whether MDMA is safe and effective against PTSD — a demand that could mean many years and millions of dollars before another chance at approval would arise. “The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” Lykos Therapeutics CEO Amy Emerson said in a statement. “While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the [agency’s] advisory committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature,” Emerson added. Many had… read on > read on >