FDA Roundup: November 19, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA issued a request for information (RFI) on per- and polyfluoroalkyl substances (PFAS) in seafood, seeking data and information from the seafood industry, academia, state and federal agencies, as well as other interested entities, on PFAS concentrations in seafood, the surrounding environment, and processing water, as well as mitigation strategies for reducing exposure to PFAS in seafood. This RFI is part of the FDA’s continued work to increase our understanding of the potential for PFAS exposure from seafood and to reduce dietary exposure to PFAS that may pose a health concern.
• On Monday, the FDA posted a new Consumer Update, Know When and How to Use Antibiotics, and When to Skip Them. Antibiotics save lives but aren’t the answer for every illness. Antibiotics treat only some infections caused by bacteria – and none caused by viruses. In the accompanying video, the FDA’s Chief Medical Officer Dr. Hilary Marston discusses how to use antibiotics safely to get well and combat antimicrobial resistance.
• On Monday, the FDA approved PropofolVet Multidose, the first generic propofol injectable emulsion for dogs. PropofolVet Multidose is approved for use as an injectable anesthetic in dogs.
• On Sunday, the FDA issued an advisory for an outbreak of E. coli O121:H19 infections linked to organic whole and baby carrots supplied by Grimmway Farms of Bakersfield, California. The FDA’s traceback investigation identified Grimmway Farms as the common supplier of organic whole and baby carrots in this outbreak. On November 16, 2024, Grimmway Farms initiated a voluntary recall of multiple quantities and brands of bagged organic whole and baby carrots and contacted their distributing customers. The retail-packaged organic whole carrots were in stores for purchase from August 14 through October 23, 2024. The organic baby carrots have different best-if-used-by-dates ranging from September 11 through November 12, 2024. A full list of recalled products is included on the advisory for this outbreak.
• On Friday, the FDA updated the advisory, Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies with final case counts and updated sample results. The investigation managed by the FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network is complete, and the agency is now focused on post-incident actions and activities.
• On Friday, the FDA approved Revuforj (revumenib) a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older. The most common adverse reactions (≥20%) were hemorrhage, nausea, increased phosphate, musculoskeletal pain, infection, increased aspartate aminotransferase, febrile neutropenia, increased alanine aminotransferase, increased intact parathyroid hormone, bacterial infection, diarrhea, differentiation syndrome, electrocardiogram QT prolonged, decreased phosphate, increased triglycerides, decreased potassium, decreased appetite, constipation, edema, viral infection, fatigue, and increased alkaline phosphatase.
• On Friday, the FDA cleared for marketing the Ultromics Limited, EchoGo Amyloidosis 1.0, an automated machine learning-based decision support system indicated as a screening tool to inform health care providers of potential cardiac amyloidosis in patients over 65 years of age with heart failure undergoing routine cardiovascular assessment using echocardiography. Cardiac amyloidosis is a severely debilitating disease in which heart muscle becomes stiff, typically because of deposits of (amyloid) proteins, resulting in heart failure and death. Early diagnosis can lead to more effective treatment of the disease. The EchoGo Amyloidosis 1.0 received a Breakthrough Device designation and is the first marketing authorization arising from participation in the FDA’s Total Product Life Cycle Advisory Program (TAP), which aims to help spur more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health.

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