Americans could soon be eating chicken that’s grown in a lab from cultured animal cells, rather than raised at a farm or facility. The U.S. Food & Drug Administration announced Wednesday that the environment-friendly chicken made by California-based Upside Foods is safe to eat, although it is not yet fully approved for sale. “Our goal is to support innovation in food technologies while always maintaining as our priority the production of safe food,” the FDA said. “Human food made with cultured animal cells must meet the same stringent requirements, including safety requirements, as all other food.” The idea behind the firm’s production plan is to use animal cell culture technology to take living cells from chickens, then to grow those cells in a controlled environment. The business walked the FDA through its production process, establishment of cell lines and cell banks, manufacturing controls, and all components and inputs. Before its products are approved for sale, Upside still needs a grant of inspection from the United States Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) for its manufacturing facility, according to the FDA. The food itself will also require a mark of inspection from USDA-FSIS. The FDA is closely coordinating with USDA-FSIS to make sure the food would be properly regulated and labeled. UPSIDE Foods CEO and founder Dr. Uma Valeti, who is also a…  read on >  read on >

The U.S. Food and Drug Administration appears poised to approve certain naloxone products for over-the-counter use, a move that would help fight the nation’s opioid epidemic. Naloxone (Narcan, Evzio) can save lives when administered soon after the first signs of an overdose from opioids such as heroin, fentanyl, oxycodone or morphine. On Tuesday, the FDA issued a Federal Register notice that could lead to some prescription naloxone products getting approved for over-the-counter sales. The notice could also encourage development of new nonprescription naloxone products. “Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Dr. Robert Califf in an agency news release. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.” The notice cites a preliminary assessment that a naloxone nasal spray and an autoinjector “may be approvable as safe and effective for nonprescription use.” However, it isn’t a final decision or a mandate to make naloxone products available without a prescription. The FDA said it still needs more data, including packaging and labeling information, before it makes a final recommendation. In 2021, there were an estimated 107,622 drug overdose deaths in the United States, according to the U.S. Centers for Disease Control and Prevention. Nearly…  read on >  read on >

The EpiPen is a known lifesaver when someone with a serious food allergy eats something they can’t tolerate. Yet the auto-injection treatment is greatly underused in the United States, according to a new survey. Just over half of at-risk adults said they had ever been prescribed the device, researchers found. And more than one-third of severe allergy sufferers mistakenly believe the EpiPen itself is a serious threat to their health. “The results were eye-opening,” said study co-author Erin Malawer, executive director of AllergyStrong based in McLean, Va. Food allergy affects more than 32 million Americans. EpiPens contain epinephrine, the only medication able to stop life-threatening anaphylaxis, which can occur from a severe allergic reaction. Roughly 1,000 patients were surveyed online. Those without EpiPens on hand gave a wide range of reasons, among them insurance issues. Without health coverage, Malawer said the injectors cost hundreds of dollars for a two-pen set, which is standard protocol. Brand name EpiPens, marketed by Mylan pharmaceuticals, retail for about $700, while generic versions are about $350, according to healthshare101.com. Survey respondents also cited a lack of access to doctors and/or pharmacies; out-of-stock pharmacies; and fear of needles. “The biggest surprise was that a staggering 25.6% of our respondents replied that the reason they did not have an (EpiPen) was because their doctor did not indicate it was needed,” Malawer added.…  read on >  read on >

Signing up for “food stamps” might help lower-income seniors preserve their mental capabilities, a new U.S. study suggests. Researchers found that eligible older adults who used the government’s Supplemental Nutrition Assistance Program (SNAP) — commonly called food stamps — had two fewer years of mental decline over a 10-year period than those who could have registered for the program but did not. “Less than half of the older adults who are eligible for SNAP actually participate,” said senior study author Adina Zeki Al Hazzouri, an assistant professor of epidemiology at Columbia University Mailman School of Public Health, in New York City. “With the number of people with Alzheimer’s disease and other dementias expected to increase, this low participation is a huge, missed opportunity for dementia prevention,” Zeki Al Hazzouri added in a school news release. The study included more than 3,500 people, average age 66. All met the income requirements for SNAP benefits, but only 559 used the program, the researchers said. The study participants had memory function tests every two years for 20 years. These involved recalling a list of words and answering questions about what they could remember from their everyday lives. SNAP users had lower income and a greater number of chronic conditions at the beginning of the study than those who opted not to participate in the program, according to the…  read on >  read on >

The U.S. Food and Drug Administration on Tuesday warned health care workers to look out for patients who may have been exposed to a potentially deadly animal sedative, possibly through illicit drug use. The veterinary medication xylazine is sometimes added to fentanyl, heroin or other drugs, after either being diverted from the legal animal supply or illicitly produced, the FDA said. “FDA is aware of increasing reports of serious side effects from individuals exposed to fentanyl, heroin, and other illicit drugs contaminated with xylazine,” the agency announced in a news release. The non-opioid — sometimes called tranq — is approved for use in animals as a sedative and pain reliever. It is not safe for use in humans. Deaths tied to xylazine have increased significantly in recent years. According to the U.S. National Institute on Drug Abuse, overdose deaths involving xylazine jumped from 2% to 26% in Pennsylvania alone between 2015 and 2020. Serious side effects may resemble those linked to opioid use, making it difficult to distinguish opioid overdoses from xylazine exposure. Moreover, naloxone, which can reverse the effects of some opioid drug overdoses, may not have the same effect on xylazine, the agency said. The FDA warned health care professionals not to administer reversal agents used for xylazine in veterinary medicine because it is not known whether they are safe or effective in…  read on >  read on >

TUESDAY, Nov. 8, 2022 (HealthDay News) – Some patients with high blood pressure can’t get it under control with standard medications, but a new study shows an experimental drug is up to the task of treating these tough-to-treat cases. Why do some folks struggle more with managing their high blood pressure than others? When the hypertension is caused by the hormone aldosterone, which is responsible for how much salt the body retains, it is much harder to control, researchers explained. Enter the drug baxdrostat, which blocks an enzyme required to produce aldosterone. In the study, scientists worked with 274 participants, who were given one of three doses of the drug or a placebo along with their existing medications. Patients in the trial had blood pressure that was at least 130/80 mm Hg, even though they were taking at least three different blood pressure medications. High blood pressure is anything 130/80 or higher, while 120/80 is considered normal. When the upper number is 120-129, blood pressure is considered elevated. Researchers found that patients who were assigned to the highest dose of the new medication saw the top number drop by a full 20 points. The study even saw placebo patients lose 11 points off their top number, known as systolic blood pressure. “The likelihood always is that people were not taking every tablet every day that…  read on >  read on >

New research reinforces advice to include more whole grains in your diet. A diet heavy in “refined” grains (such as white bread, cookies and muffins) may increase your risk for heart disease and early death, while whole grains may lower it, according to the study. “We encourage people to have moderate consumption of carbohydrates and to have different types of grain, especially whole grain,” said lead researcher Mahshid Dehghan, of the Population Health Research Institute at McMaster University in Hamilton, Ontario, Canada. “Reduction in quantity and improving the quality of carbohydrates is the message of our study,” Dehghan said. Grains like oats, rice, barley and wheat make up about half of diets around the world and as much as 70% in low- and middle-income countries, particularly in Africa and South Asia, the researchers noted. The findings don’t prove that a diet heavy in refined grains causes stroke, heart attacks or other forms of heart disease, only that there seems to be a link. For the study, the research team collected data on more than 137,000 people in 21 countries who were aged 35 to 70, had no history of heart disease and were tracked for more than nine years. People who reported eating 12 ounces of refined grains a day were found to have 27% higher odds of early death and a 33% higher risk…  read on >  read on >

New research reinforces advice to include more whole grains in your diet. A diet heavy in “refined” grains (such as white bread, cookies and muffins) may increase your risk for heart disease and early death, while whole grains may lower it, according to the study. “We encourage people to have moderate consumption of carbohydrates and to have different types of grain, especially whole grain,” said lead researcher Mahshid Dehghan, of the Population Health Research Institute at McMaster University in Hamilton, Ontario, Canada. “Reduction in quantity and improving the quality of carbohydrates is the message of our study,” Dehghan said. Grains like oats, rice, barley and wheat make up about half of diets around the world and as much as 70% in low- and middle-income countries, particularly in Africa and South Asia, the researchers noted. The findings don’t prove that a diet heavy in refined grains causes stroke, heart attacks or other forms of heart disease, only that there seems to be a link. For the study, the research team collected data on more than 137,000 people in 21 countries who were aged 35 to 70, had no history of heart disease and were tracked for more than nine years. People who reported eating 12 ounces of refined grains a day were found to have 27% higher odds of early death and a 33% higher risk…  read on >  read on >