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 >

While research has shown that having pets can lower the chances of respiratory allergies in children, a new study finds it might also reduce the risk of food allergies. Japanese investigators found that young children exposed to dogs in the home were less likely to experience egg, milk and nut allergies, while those exposed to cats were less likely to be diagnosed with egg, wheat and soybean allergies. Still, “pet exposure does not completely prevent food allergies,” noted first study author Dr. Hisao Okabe, from the Fukushima Regional Center for the Japan Environment and Children’s Study and the department of pediatrics at Fukushima Medical University in Japan. “All this study has shown is that it may reduce the risk of developing food allergies. In addition, the association between pet exposure and food allergies might differ, depending on the pet species and causative food,” Okabe added. For the study, Okabe’s team analyzed medical and self-reported data on more than 66,000 infants in Japan, and found that those exposed to indoor cats or dogs during pregnancy or early infancy had fewer food allergies, at least until the age of 3. About 22% of those infants were exposed to these indoor pets. There was no significant difference for children exposed to outdoor dogs. Why children with pets may have fewer food allergies wasn’t determined in this study, but…  read on >  read on >

The U.S. Food and Drug Administration on Wednesday approved the over-the-counter use of a nasal spray that can reverse an opioid overdose. Research has shown that wider availability of naloxone (Narcan) could save lives as the opioid epidemic rages on in this country. “The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” FDA Commissioner Dr. Robert Califf said in an agency news release. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country,” Califf said. “We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.” Emergent BioSolutions, the Maryland company that makes the Narcan spray, made no mention of price in a statement it released after the FDA approval was announced, but the company’s president applauded the move. The approval “marks a historic milestone as we have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country,”…  read on >  read on >

If you are experiencing mysterious recurrent vomiting, diarrhea and abdominal pain, you may want to consider that a tick could be responsible. When the lone star tick bites a person, it can transmit something called “alpha gal,” the sugar that’s present in all mammals except humans, explained Dr. Sarah McGill. She is an associate professor of gastroenterology and hepatology at the University of North Carolina School of Medicine in Chapel Hill. That transmission can lead to alpha-gal syndrome, a tick-borne meat allergy. If you have it, you might have gastrointestinal (GI) symptoms several hours after eating meat and sometimes milk products. McGill is lead author of a clinical practice update on the GI effects of alpha-gal syndrome published in the April issue of the journal Clinical Gastroenterology and Hepatology. “We want the update to raise awareness,” McGill said in a university news release. “When a patient has symptoms such as abdominal pain, diarrhea, nausea, vomiting — which admittedly are very nonspecific — among the things we want people to think about is alpha-gal syndrome.” The lone star tick is found in North Carolina, the Midwest and southern United States. In some cases, it can take months after the tick bite to start feeling sick after consuming meat. “When I was first diagnosing patients with alpha-gal syndrome, it wasn’t in the GI literature at all,” recalled…  read on >  read on >