Another experimental drug meant for Alzheimer’s disease looks so promising that drugmaker Eli Lilly plans to ask the U.S. Food and Drug Administration for full approval by the end of June. Known as donanemab, the medication clears amyloid plaque from the brain. In a late trial, the drug slowed memory and thinking declines in early symptomatic Alzheimer’s patients by more than a third, Lilly said Wednesday. About 47% of those taking the medication had no decline on a key measure of thinking over a year, compared to 29% of patients on a placebo. “We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer’s disease in this trial,” Dr. Daniel Skovronsky, Lilly’s chief scientific and medical officer and president of Lilly Research Laboratories, said in a company news release. “This is the first Phase 3 trial of any investigational medicine for Alzheimer’s disease to deliver 35% slowing of clinical and functional decline.” But there were some risks noted in the results. The Lilly trial involved 1,700 patients, three of whom died during the study. Two of those deaths were attributed to brain swelling or microbleeds called amyloid-related imaging abnormalities (ARIA). “We are encouraged by the potential clinical benefits that donanemab may provide, although like many effective treatments for debilitating and fatal diseases, there are associated risks that may…  read on >  read on >

The U.S. Food and Drug Administration is once again warning consumers to avoid muscle-building “supplements” that are anything but a safe alternative to steroids. In an advisory sent out last week, the agency said it continues to receive reports of serious side effects linked to selective androgen receptor modulators (SARMs). The compounds mimic some of the effects of testosterone, and have long been under study for treating muscle-wasting and bone loss caused by certain medical conditions. None have been approved by the FDA, however, and the agency stresses that SARMs are drugs, not dietary supplements. Still, online companies are marketing SARM-containing products, with the help of social media. “Online vendors and social media influencers are using social media to make SARMs seem safe and effective,” the FDA said in its warning. Based on the reports the agency is receiving, that is far from the case: SARM-containing products are linked to sometimes life-threatening effects such as heart attacks, strokes and liver failure. Other side effects include testicular shrinkage, sexual dysfunction, fertility problems and even psychosis. The FDA has been warning consumers about the risks for years, and taken action against some companies that illegally market the products. But, experts said, because people are getting SARMs online from overseas companies, the problem is hard to tackle from the supply side. And from the consumer side, it may…  read on >  read on >

U.S. regulators are urging Americans to avoid Apetamin, an illegal drug used for weight gain and figure enhancement. The substance, typically sold as a syrup, is manufactured overseas, illegally imported and isn’t approved by the U.S. Food and Drug Administration. It contains a potent antihistamine called cyproheptadine, which requires a physician’s prescription in the United States. American consumers may find Apetamin online, on social media or in some retail stores, but they should not use it, the FDA warned in an agency news release. Among its dangerous side effects are potential overdose, sedation, cognitive impairment, dizziness, low blood pressure, disorientation and confusion, hallucinations, convulsions, and decreased breath and heart rates. It may lead to coma or death, the FDA said. The substance also decreases mental alertness, which may affect a person’s ability to drive a car or operate machinery. This strong antihistamine may be dangerously strengthened when taken with alcohol and other central nervous system depressants, such as hypnotics, sedatives, tranquilizers and anti-anxiety medications, the FDA said. Reports to the FDA’s Adverse Event Reporting System found young adults had taken Apetamin and experienced nervous system disorders, cardiac disorders and liver injury, the agency said. In one published report, someone who took Apetamin daily for six weeks developed autoimmune hepatitis. A chronic disease, this condition is treated with corticosteroids and immune system suppressors. It may cause…  read on >  read on >

(HealthDay News) – General Mills has recalled four varieties of its Gold Medal flour because of concerns over potential contamination with salmonella. The recalled flour has “better if used by” dates of March 27, 2024, and March 28, 2024, according to the U.S. Food and Drug Administration. The recalled products are both bleached and unbleached all-purpose flour in 2-, 5- and 10-pound bags. Other types of Gold Medal flour are not affected by the recall. Those who find recalled flour in their pantries should throw it out, the company said. The recall was issued after a sampling of the 5-pound size flour detected the potential presence of the bacteria. The FDA and the Centers for Disease Control and Prevention always recommend that consumers don’t eat raw products made with any flour. The bacteria is killed through baking, frying, sautéing or boiling. Always clean all surfaces, hands and utensils that come into contact with uncooked flour or dough. Anyone who finds recalled flour in their kitchen and discards it can contact General Mills Consumer Relations at 1-800-230-8103. About 1.2 million people are infected with salmonella each year in the United States. Healthy people may experience nausea, diarrhea, fever and abdominal pains about six hours to six days after infection. This can last four to seven days. Some people become so ill they may need to be…  read on >  read on >

Those TV ads for juicy burgers may trigger your emotions, making you believe you’ll be happier if you run out and get one for yourself. Unfortunately, a similar ad for salad does not appear to have the same emotional impact, according to new research from the University of Michigan. “Many people think that eating highly processed foods like cheeseburgers and french fries will make them happier, and these beliefs are especially strong in people struggling to control their intake of highly processed foods,” said study author Jenna Cummings, a former University of Michigan research fellow. “Regulating fast-food advertisements and changing beliefs about how highly processed foods affect emotions could help people eat more nutritious foods,” she said in a university news release. The study found that adults who did not already hold strong beliefs about how foods affect their emotions had increases in belief that they would feel good eating these types of foods. The same was not true for salads and yogurt parfaits. The aim of the study was to test how food ads affected food-related emotional expectations and whether these effects were different depending on individual “food addiction” symptoms. Past research has found that someone with food addiction can have strong cravings for highly processed foods. Other symptoms include diminished control over their intake, eating too much despite negative consequences, including distress and…  read on >  read on >

Women have heard for decades that cranberry products help prevent urinary tract infections. A new study appears to confirm that longstanding advice. About 60% of women over age 18 will suffer one or more urinary tract infections in their lifetime. About 30% will have recurrent UTIs, averaging two to three episodes a year, according to background notes with the study. A review of 50 randomized controlled trials found that taking cranberry supplements or drinking the juice reduced the risk of having repeat symptoms for a UTI by more than 25%. In children, cranberry products reduced these infections by more than 50%. People who were susceptible to a repeat infection after medical treatment such as antibiotics or probiotics saw a 53% reduction. “For the first time, we have consensus that cranberry products (concentrated liquid, capsules or tablets) work for some groups of people; specifically, people who experience recurrent UTI, children and people susceptible to UTI because of medical intervention,” said study author Jacqueline Stephens, senior lecturer in public health in the College of Medicine & Public Health at Flinders University in Australia. This updated review of research from around the world included nearly 9,000 people. Randomized controlled trials are considered the “gold standard” of research studies. “The inclusion of the totality of the global evidence and the rigorous review process means we are confident of the…  read on >  read on >

The U.S. Department of Agriculture plans to get tougher on Salmonella bacteria found in breaded, stuffed raw chicken products, the agency announced Tuesday. About 1.35 million people are infected with Salmonella bacteria each year in the United States, according to the Centers for Disease Control and Prevention. Almost a quarter of the nation’s Salmonella infections are caused by eating poultry. “USDA is taking science-based, decisive action to drive down Salmonella illnesses linked to poultry products,” said Agriculture Secretary Tom Vilsack in a USDA news release. “Today’s proposal represents the first step in a broader effort to control Salmonella contamination in all poultry products, as well as a continued commitment to protecting American consumers from foodborne illness.” The agency’s Food Safety and Inspection Service proposed declaring Salmonella an “adulterant” if the amount in the product exceeds a very low level. The chicken products under scrutiny can appear to be cooked because they are pre-browned and heat treated. Yet the chicken is raw, often cooked from frozen. Home cooks may not be cooking it for long enough to raise the internal temperature to a level that will kill the bacteria, the agency noted in a news release. The products may be stuffed with raw vegetables, butter, cheese or meat, and these ingredients may cook at different rates than the chicken. These continue to be linked to Salmonella…  read on >  read on >

People are often reminded that they are their own unique person — and a new study says that’s particularly true of the digestive tract. Dissections of a few dozen deceased individuals revealed striking differences in gastrointestinal anatomy, even among a small group of people. Some livers were larger, some intestines and colons were longer. Crucial discrepancies were observed between men and women. And some organs were even located in the wrong place, the researchers said. “I almost missed one guy’s appendix because it was growing off the back of the cecum [the pouch that forms the first part of the large intestine] instead of the front,” said lead researcher Erin McKenney, an assistant professor of applied ecology at North Carolina State University in Raleigh. “If I hadn’t flipped it over and looked in the least likely spot, I would have missed it entirely.” These variations in anatomy have powerful implications for doctors and patients, the researchers said. Surgery, medical treatments, and even lifestyle choices like diet, are often crafted to best serve an “average” person, but individual human digestive systems are far from average, the study found. “If you’re talking to four different people, odds are good that all of them have different guts, in terms of the relative sizes of the organs that make up that system,” McKenney explained. Understanding the anatomical differences between…  read on >  read on >

Need to get your shut-eye on time? What you eat could make a difference, according to a new study. Researchers found that college athletes who ate more carbohydrates and vitamins B12 and C tended to go to sleep and wake up earlier. It’s possible that these nutrients might increase synthesis of vital hormones that regulate sleep, including serotonin and melatonin, the authors said. “For athletes, success is measured not only by readiness to perform but also resiliency on and off the field,” said first author Lauren Rentz, a doctoral student at West Virginia University. “We know that sleep helps the body heal from daily physical and mental stress and influences future physical and mental performance,” she said. “The relationship between sleep and nutrient intake hasn’t been researched as thoroughly in high-performing athletes, who consistently experience large amounts of stress.” For the study, researchers evaluated sleep and nutritional patterns of 23 women who play college soccer. Each of the athletes wore a smart ring that tracked their sleep for 31 straight nights during the season. They also recorded their food intake during the final three days. The study found links between nutrient consumption and sleep timing but not duration. Most of the athletes averaged seven to eight hours of sleep a night. They also met recommended intake for many vitamins, but not for all their nutritional…  read on >  read on >

The U.S. Supreme Court ruled on Friday that the abortion pill mifepristone can remain widely available while litigation over its fate winds its way through the court system. In the meantime, the order effectively halts a ruling from a federal judge in Texas that said the U.S. Food and Drug Administration’s approval of the pill more than two decades ago was invalid. Following the Supreme Court ruling, President Joe Biden issued a statement saying, “As a result of the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts. I continue to stand by FDA’s evidence-based approval of mifepristone, and my Administration will continue to defend FDA’s independent, expert authority to review, approve and regulate a wide range of prescription drugs.” Friday’s order is just the second time in a year that the Supreme Court has considered slashing access to abortion in the United States. In overturning Roe v. Wade last June, a conservative majority said it was leaving the issue of abortion to elected officials. It was only last Wednesday when a federal appeals court partially overruled Judge Matthew Kacsmaryk’s April 7 ruling made in Texas, which said the U.S. Food and Drug Administration’s approval of mifepristone back in 2000 was invalid and the drug should not be used. While the three-judge appeals…  read on >  read on >