Older adults may have a second vaccine option for RSV following the U.S. Food and Drug Administration’s approval of a Pfizer vaccine on Wednesday. The other shot for adults 60 and up is made by GSK. It was approved May 3. Both should be available by fall, before the seasonal spread of respiratory syncytial virus (RSV), The New York Times reported. The Pfizer vaccine, known as Abrysvo, has effectiveness of nearly 67% when a patient has two symptoms of RSV, such as a sore throat and cough. It’s 86% effective when three or more symptoms surface. Its GSK competitor — named Arexvy — was about 83% effective against severe RSV, the Times reported. The study on the Pfizer vaccine did include a concern about autoimmune syndromes. One patient among the 34,000 who received the vaccine in the study developed a life-threatening case of Guillain-Barré syndrome a week after receiving the shot. Another developed Miller Fisher syndrome, which is a subtype of that condition. That means the incidence rate for these syndromes is 1 in 9,000, higher than the 1 in 100,000 seen in the general population. FDA advisors voted 7 to 4 in favor of the vaccine’s safety and efficacy. It had voted 10 to 2 for the GSK vaccine, which was linked to similar cases. Advisers for the U.S. Centers for Disease Control and…  read on >  read on >

(HealthDay News) – Patients taking semaglutide for type 2 diabetes or weight loss should be careful about where they’re getting the medication, the U.S. Food and Drug Administration warned Tuesday. Shortages of the drug, commonly sold as Wegovy and Ozempic, has led to the making of compounded versions of the drugs, which is combining or mixing ingredients to meet patient needs. Compounders can make a version of a drug if the medication is in shortage and they meet requirements of the Federal Food, Drug and Cosmetic (FD&C) Act. But the FDA said it has received reports that some patients have had some problems after taking the compounded drugs. The agency warned that patients should not use a compounded drug if an approved drug is available. Patients and their doctors should also understand that the FDA does not review compounded drugs for safety, effectiveness or quality. Compounded medications are not FDA-approved. Among the issues are reports that compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than those used in the approved drugs. The agency said it has expressed concern to the National Association of Boards of Pharmacy about the use of salt forms of semaglutide in these products. Patients intending to use semaglutide should have a prescription from a licensed health care provider…  read on >  read on >

You’ll likely lose some of your memory and thinking abilities as you age, but nutrients called flavanols might help thwart that decline, a new study suggests. Not getting enough flavanols — natural compounds found in fruits, vegetables and even chocolate — could be driving that age-related memory loss, researchers say. This research is the pinnacle of 15 years of work showing that flavanols seem to benefit the dentate gyrus, an area within the brain’s hippocampus that is critical to memory. “This is the first time we can conclude that flavanols are acting as a nutrient for the aging brain,” said Dr. Scott Small, a professor of neurology and director of the Alzheimer’s Disease Research Center at Columbia University College of Physicians and Surgeons. “We show in this study, because we had biomarkers of flavanols, that if you’re relatively deficient in your flavanols, that seems to be driving your age-related memory decline.” This study was funded by the U.S. National Institutes of Health and Mars Edge, a subsidiary of the candy company. It’s possible that just as babies need certain nutrients for their developing brains, the aging brain also requires specific nutrients for optimal health, Small said. Now that people live longer, scientists are looking into a series of recommendations of nutrients that are beneficial for the aging body and brain, he noted. “I’d like to…  read on >  read on >

The last thing you want to invite to your Memorial Day cookout is foodborne illness. An expert from Virginia Tech offers some suggestions for keeping it at bay, even when cooking something you may have less experience with, such as plant-based or turkey burgers instead of beef patties. “If you choose the classic ground beef burger, it should be cooked to an internal temperature of 160° F, or 71° C,” said Melissa Wright, director of the Food Producer Technical Assistance Program in the College of Agriculture and Life Sciences’ Department of Food Science and Technology at Virginia Tech. “There are many alternative burger options, and knowing the correct internal temperature for each type is the best way to make sure your long weekend isn’t ruined by foodborne illness,” Wright added. For ground chicken or turkey, the appropriate temperature is 165° F. Impossible burgers, made with soy protein, should be cooked to 160° F. Their Beyond burgers counterparts, made with pea protein, and Morningstar Farms burgers, with chickpea protein, need to reach 165° F. That’s also the temperature that black bean burgers should reach, Wright advised. Ground bison needs to reach 160° F. Both ground elk and ground salmon need to get to 145° F. “Food continues to cook after being removed from the heat source, so it’s alright to remove your burger from the grill…  read on >  read on >

Americans with COVID-19 have been taking Paxlovid since it was approved under emergency use in late 2021. Today, the U.S. Food and Drug Administration granted full approval to the drug. This approval will allow drugmaker Pfizer to sell the medication at market rate once government supplies are used up. Paxlovid is the fourth antiviral drug and first pill approved by the FDA to treat COVID. It’s meant to keep at-risk adults from progressing to severe COVID symptoms, including hospitalization and death. “Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in an agency news release. The approval was made using results from the randomized EPIC-HR clinical trial. That trial studied adults who had a lab-confirmed COVID infection and symptoms but were not hospitalized. They each had a risk factor for severe disease, such as obesity or diabetes, or were 60 years and older. These patients had not received a COVID vaccine or been infected before. The study found that Paxlovid reduced odds of hospitalization or death by 86% compared to those given a placebo within five days of symptom onset. The patients…  read on >  read on >

The U.S. Food and Drug Administration on Monday approved a second nasal spray for reversing an opioid overdose. To be sold as Opvee, the spray contains the medication nalmefene hydrochloride and will be available to Americans aged 12 and older with a prescription, the FDA said. “The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the development of novel overdose reversal products,” FDA Commissioner Dr. Robert Califf said in an agency news release. “On the heels of the FDA’s recent approval of the first over-the-counter opioid reversal agent [Narcan], the availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders,” Califf added. Indivior, which will make and sell Opvee going forward, said the spray should be available by October. Indivior bought Opiant Pharmaceuticals, which developed Opvee, in March. “Opvee’s FDA approval represents a significant achievement in the development of new treatment options to address today’s era of opioid overdoses that are driven by powerful synthetic opioids, such as fentanyl,” Indivior CEO Mark Crossley said in a company news release. “Opvee is an emergency treatment for the fast reversal of respiratory depression triggered by natural or synthetic opioids, including fentanyl, and we are committed to making this novel rescue medication widely available…  read on >  read on >

Patients with Crohn’s disease have a new treatment option, following U.S. Food and Drug Administration approval of a pill called Rinvoq (upadacitinib). Rinvoq is meant to treat adults with moderately to severely active Crohn’s disease who have not had success with TNF (tumor necrosis factor) blockers. The daily pill is the first oral treatment for this group of patients. Crohn’s is a chronic inflammatory bowel disease. It causes inflammation in any part of the digestive tract, typically affecting the small intestine and the beginning of the large intestine. Common symptoms include diarrhea, cramping, stomach pain and weight loss. The medication was previously approved for several other conditions, including eczema, rheumatoid arthritis, psoriatic arthritis and ulcerative colitis, according to the website of pharmaceutical company AbbVie. Researchers evaluated its safety and effectiveness in two randomized trials in 857 patients with the disease. Participants received either 45 mg of Rinvoq or a placebo daily for 12 weeks. More patients treated with the medication achieved remission than those treated with the placebo, the FDA said in a news release. Also, more people treated with the medication had improvement in intestinal inflammation, which was assessed with a colonoscopy. The FDA also assessed Rinvoq as a maintenance treatment, evaluating 343 patients who had responded to the 12 weeks of medication. This group received 15 mg or 30 mg once daily or…  read on >  read on >