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Following disappointing trial results, the maker of a controversial ALS drug may pull the medication off the market. In a statement issued Friday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a large follow-up study, but the company stopped just short of saying it will definitely pull the drug from the market. The drug is sold as Albrioza in Canada. “Amylyx intends to share plans for Relyvrio/Albrioza in ALS, which may include voluntarily withdrawing Relyvrio/Albrioza from the market,” the company said in its statement. “At this time, Relyvrio/Albrioza and its related patient support program will continue to be available for people living with ALS. Amylyx has voluntarily decided to pause promotion of the medication during this time.” Executives added that they were “surprised and disappointed” by the results and would announce their plans for the drug in the next two months. Relyvrio was first approved by the U.S. Food and Drug Administration in September 2022, following a lengthy, impassioned campaign by patients with ALS, a fatal muscle-wasting disease. Unfortunately, the latest company study showed the drug did not slow the disease compared with a placebo treatment, and it also did not produce improvements on any secondary measures, such as muscle strength. ALS is a devastating neurological disease slowly destroys nerve cells and connections that are needed to walk, talk, speak and breathe. Most patients die… read on > read on >

Instead of approving the new Alzheimer’s drug donanemab this month, as was expected, the U.S. Food and Drug Administration will now require the experimental medication be scrutinized more closely by an expert panel, the drug’s maker said Friday. “The FDA has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design,” the company said in a statement. The move surprised the company, which had believed the agency would give its blessing to the drug during the first quarter of this year. “We were not expecting this,” Anne White, a Lilly executive vice president and president of its neuroscience division, told the Times. While independent FDA advisory committees are often called upon when the agency has questions about drugs, it was unusual to do so “at the end of the review cycle and beyond the action date that the FDA had given us,” White noted. While the FDA did not comment on the news, Lilly officials said they expected it would be a few months before the appropriate advisory committee meets to weigh the benefits of the drug, the Times reported. “The FDA did commit to us to move quickly, so we would hope that they would then take action shortly after the… read on > read on >

Folks worried about becoming flabby in middle age should check out what their parents looked like when they were that age, a new study says. People are six times more likely to become obese in middle age if both their parents were chubby during that time of their lives, according to research to be presented at the European Congress on Obesity in May. Further, having just one obese parent more than triples a person’s odds of middle-aged obesity, researchers found. These findings demonstrate that the established association between childhood obesity and parental weight doesn’t fade as a kid ages, said lead researcher Mari Mikkelsen, a doctoral research fellow of community medicine at the Arctic University of Norway. “Obesity in childhood, and especially in adolescence, tends to follow the individual into early adulthood, and so we suspected it would also follow them into middle age,” Mikkelsen said in a meeting news release. “We found that this is indeed the case — children whose parents lived with obesity are much more likely to be in living with obesity themselves when they are in their 40s and 50s, long after they have left home,” Mikkelsen added. For this study, researchers analyzed health data on more than 2,000 parent-offspring pairs who took both took part in an ongoing health research project called the Tromso Study. All the offspring were… read on > read on >

Children with “lazy eye” are more likely to become adults facing an array of serious health problems, a new study warns. Kids diagnosed with amblyopia are more likely to develop high blood pressure, obesity and diabetes as adults, researchers found. They also face an increased risk of heart attack, according to findings published March 7 in the journal eClinicalMedicine. “Vision and the eyes are sentinels for overall health,” said lead author Dr. Siegfried Wagner, a senior research fellow with the University College London Institute of Ophthalmology. “They are intimately linked with other organ systems. This is one of the reasons why we screen for good vision in both eyes.” Amblyopia occurs when vision in one eye doesn’t develop properly. As the brain ignores the weaker eye, that eye drifts out of position and tends to face slightly away from wherever a person is looking. As many as four in every 100 children have lazy eye, researchers said in background notes. It’s the most common vision condition in children. For this study, researcher analyzed data from more than 126,000 people ages 40 to 69 participating in the ongoing UK Biobank study. As part of their medical history, participants were asked whether they were treated for amblyopia in childhood, and whether they still had the condition in adulthood. They also were asked if they had been diagnosed with… read on > read on >

Ambien, Lunesta, Sonata: Millions of bleary-eyed Americans turn to this class of so-called “Z-drugs” to get restful sleep. But how do these drugs work, and do they come with risks? Experts at the U.S. Food and Drug Administration have issued an advisory to boost awareness about the meds. All of these medications — generically known as zolpidem (Ambien, Ambien CR, Edluar and Zolpimist), eszopiclone (Lunesta) and zaleplon (Sonata) — work by putting the brakes on brain activity, allowing you to drift off to sleep. But the FDA warns that Z drugs also come with risks, most notably upping your odds for “complex sleep behaviors” — things like sleepwalking, sleep driving, sleep cooking or even taking other medicines. “The FDA has received reports of people taking these insomnia medicines and accidentally overdosing, falling, being burned, shooting themselves and wandering outside in extremely cold weather, among other incidents,” the agency noted. You might not even recall any of these behaviors occurring once you reawaken, according to the FDA. The onset of complex sleep behaviors tied to Z drug use is also unpredictable. For some, the behavior can begin after the first dose, while for others it might begin much later into use. Many sleep medicines can also cause daytime drowsiness, so avoid driving and other hazardous tasks under those circumstances. Some other tips for safe use of… read on > read on >

Put down that donut and lay off the pasta: New research finds you’re less sexy after gorging on refined carbs. French researchers presented heterosexual adults with photos of an opposite-sex person who two hours earlier had eaten a breakfast rich in refined carbohydrates. Participants rated the folks in the photos as less attractive compared to people who’d eaten a healthier breakfast. “Facial attractiveness, an important factor of social interactions, seems to be impacted by immediate and chronic refined carbohydrate consumption in men and women,” concluded a team led by Amandine Visine of the University of Montpelier. Her team published its findings March 6 in the journal PLOS One. According to the researchers, “refined” carbohydrate foods are ubiquitous in the Western diet, and include highly processed fare stripped of much of its nutritional value. White flour plus refined sugar are often ingredients, and many snacks are high in refined carbohydrates. According to a news release from the journal’s publisher, “preliminary evidence has suggested that consuming high levels of refined carbohydrates might also affect non-medical traits, such as a person’s attractiveness.” To investigate further, the French team recruited 104 white male and female adults. Some were told to eat a high-glycemic breakfast loaded with refined carbs that are known to boost blood sugar levels. Others ate a low-glycemic breakfast that avoided refined carbs. All of the participants… read on > read on >

Food allergies are difficult to manage at any age, but college students face complex challenges when it comes to navigating the dangers posed by the possibility of life-threatening anaphylaxis. A recent review published in the Annals of Allergy, Asthma and Immunology, the journal of the American College of Allergy, Asthma and Immunology, examines recent evidence and addresses hurdles facing college students with food allergies, along with possible strategies to overcome those challenges. Senior study author Dr. Edward Iglesia, an instructor of medicine in the Division of Allergy, Pulmonary and Critical Care Medicine at Vanderbilt University Medical Center in Nashville, Tenn., said the first priority is to confirm that your college student still suffers from a food allergy. “Sometimes we miss the opportunity to reassess if someone’s food allergies have resolved,” he explained. “The transition to adulthood is a great time to do this, and the high school years can be a ‘signpost’ to take the time to re-confirm a food allergy.” If your prospective college student hasn’t been evaluated for his or her food allergy in the past few years, it’s worth talking to your allergist about getting re-evaluated. Meeting with your child’s allergy team provides an opportunity to review practical strategies to safely navigate their condition, as well as helping cultivate the confidence and resilience to do so. Advance planning can help with unsettled… read on > read on >

The U.S. Food and Drug Administration issued a health advisory Wednesday warning consumers that six brands of ground cinnamon are tainted with lead. The FDA urged folks to throw away and not buy the following brands of ground cinnamon: La Fiesta, sold at La Superior SuperMercados Marcum, sold at Save A Lot MK, sold at SF Supermarket Swad, sold at Patel Brothers Supreme Tradition, sold at Dollar Tree and Family Dollar El Chilar, sold at La Joya Morelense in Baltimore The new list of tainted ground cinnamon products resulted from an October 2023 recall of cinnamon applesauce and apple puree products due to elevated lead levels, the FDA said. That recall prompted FDA to test ground cinnamon sold in discount retail stores for the presence of lead or chromium. The FDA has recommended that the companies behind these ground cinnamon brands recall their products, the agency said. Lead is toxic to humans, particularly children, and there is no safe level of exposure, the U.S. Centers for Disease Control and Prevention says. Initial symptoms of lead poisoning may include headaches, stomach and muscle aches, vomiting, anemia, irritability, fatigue and weight loss. Children are especially vulnerable to lead exposure because of their smaller body sizes and rapid metabolism and growth, the FDA noted. Exposure can cause developmental delays in children such as learning disabilities, behavioral problems and… read on > read on >

Statins have become the miracle medicine of modern heart care, lowering cholesterol levels and and guarding against heart attacks in millions of Americans. In fact, a running joke among doctors holds that statins are so helpful they should be put in the water supply. However, they aren’t right for all patients, and some rare side effects can crop up with the meds, said Dr. Melissa Tracy, a cardiologist with Rush University Medical Center in Chicago. Here is a primer on what statins are, who should use them and what dangers they can pose to some patients. What are statins? Statins are medications that reduce blood levels of “bad” LDL cholesterol that can accumulate into plaques that clog arteries. Statins can also reduce inflammation in patients, and might help lower blood pressure. People need a prescription to take statins, and most will take them for life once they start — even if their LDL cholesterol levels go down. “I have had some patients that I can get off of a statin, but it tends to be one of those agents that we use lifelong,” Tracy said in a Rush news release. Still, folks on statins may need to stop taking them if they experience changes in liver function, become pregnant, start menopause or have other health changes, Tracy added. There are many different types of statins,… read on > read on >

Sipping sodas – sugary or diet – seems to slightly increase a person’s risk of developing a potentially dangerous irregular heart rhythm, a new study shows. Folks had a 20% greater risk of atrial fibrillation if they drank two liters or more of artificially sweetened beverages each week, researchers reported March 5 in the American Heart Association journal Circulation: Arrhythmia and Electrophysiology. Two liters of sugar-sweetened beverages came with a 10% higher risk of a-fib. Meanwhile, consuming one liter of unsweetened fruit or vegetable juice every week conferred an 8% lowered risk. “Our study’s findings cannot definitively conclude that one beverage poses more health risk than another due to the complexity of our diets and because some people may drink more than one type of beverage,” said lead author Dr. Ningjian Wang, a researcher at the Shanghai Ninth People’s Hospital and Shanghai Jiao Tong University School of Medicine in Shanghai. “However, based on these findings, we recommend that people reduce or even avoid artificially sweetened and sugar-sweetened beverages whenever possible,” Wang added in a journal news release. “Do not take it for granted that drinking low-sugar and low-calorie artificially sweetened beverages is healthy. It may pose potential health risks.” For the study, researchers reviewed dietary and genetic data for more than 200,000 adults who enrolled in the UK Biobank long-term health study between 2006 and… read on > read on >