The U.S. Food and Drug Administration on Wednesday approved the first fecal microbiota treatment, aimed at helping adults battling tough-to-treat Clostridium difficile (C. diff) infections. “Today’s approval of Rebyota is an advance in caring for patients who have recurrent C. difficile infection [CDI],” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Marks said in an agency news release. “As the first FDA-approved fecal microbiota product, today’s action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI.” Prior to this approval, the infection has been treated using stool samples from healthy donors. Adding healthy bacteria from the donor gut in what is called fecal transplant helps fight the recipient’s infection. Rebyota, from Ferring Pharmaceuticals Inc., is still prepared from human stool. Donors are tested for a range of transmissible pathogens, though there is still the possibility of transmitting infections, the FDA noted. The treatment is administered rectally in one dose. Two randomized, double-blind clinical studies and some open label clinical studies were completed prior to the approval to assess safety, involving a total of 978 adults. In one study, the most common side effects among 180 Rebyota recipients when compared to 87 placebo recipients were abdominal pain, diarrhea, abdominal bloating,…  read on >  read on >

THURSDAY, Dec. 1, 2022 (HealthDay News) – U.S. Food & Drug Administration policies that have limited blood donations from men who have sex with men may soon ease. At the moment, FDA policy does not allow blood donation from men who have had sex with other men in the past three months. That’s already a shorter timeframe than in the past, when the agency required a one-year gap. The agency is now considering switching to questionnaires that focus on individual risk, rather than blanket limitations, CNN reported. “The FDA remains committed to gathering the scientific data related to alternative donor deferral policies that maintain a high level of blood safety,” the agency said in a statement issued Wednesday. “We anticipate issuing updated draft guidance in the coming months.” Information collected through a donor eligibility questionnaire and blood surveillance “will likely support a policy transition to individual risk-based donor screening questions for reducing the risk of HIV transmission,” the agency added, CNN reported. The FDA changed those guidelines in 2020 as the need for blood donations grew during the pandemic, CNN reported. “While today’s reports of an overdue move from the FDA is an important step, our community and leading medical experts will not stop advocating for the FDA to lift all restrictions against qualified LGBTQ blood donor candidates,” Sarah Kate Ellis, CEO and president of…  read on >  read on >

Toss out your salt shaker if you want to lower your risk of heart disease, a new study suggests. Even if you already follow a low-salt diet, sprinkling salt on your food can raise your risk for heart disease, heart failure and plaque in cardiac arteries, researchers report. “Compared with people who always added salt to foods — usually at the table — those who sometimes, rarely or never added salt to foods had up to 37% reduction in the risk for cardiovascular disease,” said lead researcher Dr. Lu Qi, a professor in the department of epidemiology at Tulane University School of Public Health and Tropical Medicine in New Orleans. “Our findings suggest the potential to prevent cardiovascular disease through behavioral changes — reduction of adding salt to foods,” he said. This study, published Nov. 28 in the Journal of the American College of Cardiology, cannot prove that adding salt to your food causes heart disease, only that the two are related. For the study, Qi and his colleagues collected data on the use of salt among more than 176,000 adults. They also looked at the association among adding salt to foods, the DASH diet and the risk for heart disease. The DASH diet was designed to lower blood pressure and is rich in fruits, vegetables, whole grains and low-fat dairy foods. It includes meat,…  read on >  read on >

Americans are eating more whole grains than ever before — but it’s still not enough. Moreover, not everyone agrees on what whole grains actually are, according to a new study that found competing definitions. The increase in whole grain intake over the past two decades is either 39.5% or 61.5%, according to researchers from the Tufts University Friedman School of Nutrition Science and Policy in Boston. But by any definition, Americans are not getting the recommended amount of at least 3 ounces daily. Researchers studied overlapping definitions from the Dietary Guidelines for Americans, the U.S. Food and Drug Administration, the American Heart Association, the American Association of Cereal Chemists International and the Whole Grains Council. They noted a need to standardize how consumers, researchers and policymakers talk about whole grain foods. Using these varying definitions, the research team analyzed the dietary intakes of more than 39,700 adults who participated in the National Health and Nutrition Examination Survey (NHANES) between 2003 and 2018. “We found that each definition captured very different types of grain- or flour-containing foods as whole grain foods, resulting in differences in the average consumption of whole grain foods and the associated trends,” study lead author Mengxi Du said in a Tufts news release. She is a PhD candidate in nutrition epidemiology and data science. Whole grain bread consumption increased under all definitions.…  read on >  read on >

MONDAY, Nov. 28, 2022 (HealthDay News) — Intermittent fasting — limiting eating to a small part of the day — is very popular these days. But that doesn’t mean it’s healthy. A new study published online in the Journal of the Academy of Nutrition and Dietetics suggests that people who skipped meals, fasted or ate their meals too closely together overall had higher risks of premature death. “At a time when intermittent fasting is widely touted as a solution for weight loss, metabolic health and disease prevention, our study is important for the large segment of American adults who eat fewer than three meals each day,” said lead author Dr. Yangbo Sun. She’s an assistant professor of preventive medicine at the University of Tennessee Health Science Center. “Our research revealed that individuals eating only one meal a day are more likely to die than those who had more daily meals,” Sun said in a journal news release. Participants who skipped breakfast were more likely to develop fatal heart diseases, Sun said. Those who skipped lunch or dinner increased their risk of premature death from all causes. Even those who ate three meals a day but had them closer together than 4.5 hours apart had higher risk, the study found. “Based on these findings, we recommend eating at least two to three meals spread throughout the…  read on >  read on >

People with one form of the genetic blood disorder hemophilia now have a one-time treatment with a $3.5 million price tag. The U.S. Food and Drug Administration approved the new gene therapy Hemgenix on Nov. 22. Soon after, drugmaker CSL Behring revealed its cost. The company said its drug would ultimately reduce health care costs because patients with the genetic disorder would need fewer treatments for bleeding, the Associated Press reported. As with most approved drugs, private or government insurance — not patients — is expected to foot the bill. Hemgenix is designed for adults with hemophilia B, the less common form of the disease. Currently, patients receive costly IV infusions to promote clotting and prevent bleeding. The treatment is also for people who have repeated, serious spontaneous bleeding episodes. “Gene therapy for hemophilia has been on the horizon for more than two decades. Despite advancements in the treatment of hemophilia, the prevention and treatment of bleeding episodes can adversely impact individuals’ quality of life,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “[This] approval provides a new treatment option for patients with hemophilia B and represents important progress in the development of innovative therapies for those experiencing a high burden of disease associated with this form of hemophilia,” Marks said in an FDA news release. In hemophilia B,…  read on >  read on >