(HealthDay News) – Juul Labs on Wednesday reached a $462 million settlement with several states over the aggressive marketing of its electronic cigarettes to minors. This latest settlement includes New York, California, Colorado, the District of Columbia, Illinois, Massachusetts and New Mexico. Juul settled with West Virginia earlier this week. The company has already agreed already to pay out more than $1 billion to 47 states and territories, Juul Labs said in a statement. “The terms of the agreement, like prior settlements, provide financial resources to further combat underage use and develop cessation programs and reflect our current business practices,” Juul spokesman Austin Finan told the New York Times. The latest settlement represents a near “total resolution of the company’s historical legal challenges and securing certainty for our future,” he added. Finan noted that federal data shows that underage use of Juul products has declined 95% since 2019. State attorneys general in New York and California alleged that their investigations found that Juul executives knew their marketing was attracting teens, the Times reported. “Too many young New Yorkers are struggling to quit vaping and there is no doubt that Juul played a central role in the nationwide vaping epidemic,” New York Attorney General Letitia James said in a statement on the settlement. While the company hasn’t admitted wrongdoing, its payments to plaintiffs in earlier lawsuits…  read on >  read on >

As people with HIV live longer they’re at risk of premature heart disease. But a new study finds statin drugs can cut the risk of serious heart problems by more than one-third. The U.S. National Institutes of Health trial found the cholesterol-lowering drugs so effective, in fact, that the study was stopped early. Taking the daily statin pitavastatin calcium lowered the risk of major heart events by 35% in this patient group, according to an interim analysis of data from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study. “The REPRIEVE study reflects the evolution of HIV science, and progress from focusing mostly on approaches to treat and control the virus to finding ways to improve the overall health of people living with HIV,” said Dr. Hugh Auchincloss, acting director of the National Institute of Allergy and Infectious Diseases (NIAID). “These new data suggest that a common cholesterol-lowering medicine could substantially improve cardiovascular outcomes in people with HIV,” he said in a news release from the NIH and the NIAID. As people with HIV live longer thanks to decades of medical research and advances, premature heart disease and other chronic conditions have emerged as leading causes of illness and death. Statins are known to prevent heart disease in those at risk in the general population. But researchers weren’t certain before the trial if…  read on >  read on >

(HealthDay News) – The U.S. Justice Department on Monday appealed a Texas court ruling that invalidates the U.S. Food and Drug Administration’s approval in 2020 of mifepristone, the first of two drugs taken during a medical abortion. The ruling by U.S. District Judge Matthew Kacsmaryk in Texas is “extraordinary and unprecedented,” the Justice Department said in its appeal. “If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity.” Pharmaceutical executives have also weighed in on the ruling, signing a letter on Monday warning about the impact if the Texas order was to take effect. “If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” stated the letter, according to the Associated Press. While Kacsmaryk’s ruling said the order would not take effect for seven days, within 20 minutes of the order a federal judge in Washington state issued a ruling directing the FDA to make no changes that would restrict access to the drug in 17 states where Democrats had sued, the AP reported. The Justice Department has asked for clarification on that ruling. The Texas lawsuit was filed…  read on >  read on >

Intermittent fasting is all the rage due to its laundry list of potential health benefits — from weight loss to longevity. Now, new research suggests that it may beat low-calorie diets when it comes to preventing type 2 diabetes in high-risk people. Folks who only ate between 8 a.m. and noon for three days a week and ate normally for the other four days showed greater improvements in blood sugar metabolism for at least six months when compared with people who followed a low-calorie diet. Interestingly, folks in both groups lost the same amount of weight during the study period. “Our study indicates that meal timing and fasting advice extends the health benefits of a restricted calorie diet, independently from weight loss, and this may be influential in clinical practice,” said study author Xiao Tong Teong, a postdoctoral researcher at the University of Adelaide in Australia. For the study, researchers compared a time-restricted intermittent fasting diet to a low-calorie diet in more than 200 people, to see which had a greater effect on the risk for developing type 2 diabetes. They looked at postprandial blood sugar, a measure of glucose in the bloodstream after eating. If these levels are too high, it suggests a greater risk of type 2 diabetes, the form of the disease most closely related to obesity. Previous studies suggested eating earlier…  read on >  read on >

A Texas federal judge has issued a preliminary ruling that invalidates the U.S. Food and Drug Administration approval in 2000 of mifepristone, the first of two drugs most commonly taken during a medical abortion. Judge Matthew Kacsmaryk added a seven-day stay to his order, issued Friday, to give the FDA time to mount an appeal. About an hour later, Washington state federal judge Thomas Rice issued a countering decision in a case filed there, ordering a halt to “any action to remove mifepristone from the market or otherwise cause the drug to become less available.” The two opposing rulings would suggest that any final decision on the availability of mifepristone, which is typically given alongside misoprostol to cause an abortion, may end up at the Supreme Court. The Washington state lawsuit originated with Democratic attorneys general who were challenging restrictions in place that made it difficult to obtain mifepristone. The Texas decision involves a lawsuit filed by a coalition made up of doctors and anti-abortion groups who sought an end to the use of mifepristone, claiming that the FDA’s decision 23 years ago to approve the drug was made hastily and without proper regard for its overall safety. In his decision, Kacsmaryk said that, ”The court does not second-guess [the] FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation…  read on >  read on >

Dangerously low blood pressure is considered an “invisible” consequence of paralysis, adding to the woes of as many as 9 out of 10 people with spinal cord injuries. Now, a new implant has been developed that treats the problem by delivering electrical stimulation to a select group of spinal neurons. The device, called a neuroprosthetic baroflex, stimulates the lower part of the spine, which contains the most neurons involved in blood pressure control, researchers said. The findings were published April 6 as an essay in Science. Spinal cord injury often interferes with the brain’s ability to modulate blood pressure when a person changes posture, such as moving from a sitting to a standing position. This ability, called the baroreceptor reflex, involves a series of quick responses within the body to keep blood pressure in a normal range when someone abruptly changes position, the Cleveland Clinic says. The brain senses that artery walls are stretching due to a sudden increase in blood pressure. In response, the brain can order the body to compensate, though a series of reactions that take place within a couple of heartbeats. A person with a spinal cord injury can be rendered dizzy, nauseous or prone to fainting if their baroreceptor reflex fails and their blood pressure drops to very low levels as a result of trying to move. “Almost all of…  read on >  read on >

The U.S. Food and Drug Administration on Thursday formally withdrew its approval of a drug that was meant to prevent preterm births. Sold as Makena, the drug was first approved in 2011 under the FDA’s accelerated approval program, but subsequent research questioned the medication’s effectiveness and noted serious side effects that included blood clots and depression. “It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes — particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Dr. Robert Califf said in an agency news release. “Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved,” Califf added. The decision follows a meeting of one of the agency’s advisory committees last October where panel members voted 14-1 to recommend that Makena be pulled from the market. FDA officials have long said they want to withdraw the medication because of lack of evidence that it works and its side effects. “It would be unfair to keep the drug on the market and expose especially vulnerable populations to an ineffective therapy,” panel member Dr. Mark Hudak, a pediatrician at…  read on >  read on >

Does it sometimes feel like your young picky eater is turning every meal and snack into an epic power battle — and you’re just not sure how to get them the nutrition they need? If so, you’re not alone. According to an article published recently in the journal Pediatrics, up to 50% of kids may be described as “picky eaters.” And while there’s no one agreed-upon definition of picky eating, in general, if your child or adolescent is particular about the food they eat at least some of the time, you may have a picky eater on your hands. “I think all parents have said at one time, ‘My kid is such a picky eater!’” clinical psychologist Rachel Busman said in a recent Child Mind Institute article. “It’s very normal for kids to go through stages where they’re a little more picky, especially when they are trying to assert their autonomy.” Experts at the institute note that picky eating is one of the most “common complaints” of parents. Here, they and other child experts weigh in on the topic with five top tips for parents of picky eaters: Grocery shop and cook together Involving your child in grocery shopping can help extend their picky eater food list to include novel items, Busman explained. When they are shown a wide variety of food flavors and options,…  read on >  read on >

People at risk of heart disease could extend their lives by going Mediterranean or low-fat, according to a new analysis of popular diets. In the world of nutrition and disease, dietary fat is an often confusing subject. And in general, experts say, recent years have seen a move away from prescribing a strict amount of dietary fat, and more focus on the source of that fat: Is it from healthful foods like olive oil and nuts, or from burgers and fries? Still, the new analysis found some wins for low-fat eating. Across 40 published clinical trials, those that tested low-fat diets showed that they helped prevent heart attacks and premature deaths among people at elevated risk. That included people who’d already suffered a heart attack or stroke, and those with conditions like high blood pressure, diabetes and obesity. Low-fat diets were, at least, better than making no diet changes. However, the benefits were even greater for people in trials of the famous Mediterranean diet — high in fish, vegetables and, yes, olive oil and nuts. The diet helped people live longer, and it not only lowered their risk of heart attack, but stroke as well. Experts said the findings, published online recently in the medical journal BMJ, support what has become the common diet mantra in recent years: Eat more fish and plant-based foods, and…  read on >  read on >

Cats constantly licking and chewing because of a skin condition called feline allergic dermatitis may benefit from a new generic treatment approved by the U.S. Food and Drug Administration. The FDA approved Modulis for Cats on March 29, making it the first generic cyclosporine oral solution for cats with skin conditions resulting from this allergic dermatitis. The immunosuppressant drug tamps down the allergic process that causes cats with this condition to be itchy. The medication contains the same concentration and dosage of cyclosporine as an approved brand-name drug, Atopica for Cats. That medication was approved in August 2011. Cats with this condition can be intensely itchy. They may lick, chew and scratch at their skin and hair. This can cause them to develop other skin issues, including miliary dermatitis, lesions known as eosinophilic plaques and hair loss. Cats need to be at least 6 months old and weigh 3 pounds to use the medication, which is only available from a veterinarian. People who administer this to their cat should avoid accidentally ingesting the drug. Don’t eat, drink, smoke or use smokeless tobacco while handling it, the FDA advised. Wash your hands after giving Modulis for Cats to your pet. People with known hypersensitivity to cyclosporine should avoid contact with the product, the FDA warned. The medication is sponsored by Provetica, LLC, based in Lenexa, Kan.…  read on >  read on >