FDA Roundup: November 28, 2023

SILVER SPRING, Md., Nov. 28, 2023 /PRNewswire/ -- 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 drug safety communication warning that the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms. It may start as a rash, but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. As a result, the agency is requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines.

• Today, the FDA issued a safety communication regarding reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. The reports were received from clinical trials and/or postmarketing adverse event data sources. Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA is investigating identified risk of T-cell malignancy with serious outcomes including hospitalization and death. For more information, visit FDA's web site.

• On Monday, the FDA published the FDA Voices: "FDA Protects Patients from Harmful Drugs Through the Drug Supply Chain Security Act," by Jaqueline Corrigan-Curay, Office of the Center Director, Center for Drug Evaluation and Research (CDER) and Jill Furman, Office of Compliance, CDER. Since 2013, the FDA has been implementing the Drug Supply Chain Security Act, a law known as DSCSA. This law gives the FDA more regulatory tools to detect and help ensure the removal of dangerous drugs from the supply chain, such as those that may be counterfeit, stolen, contaminated, or otherwise harmful. By fully implementing DSCSA, together with industry and other stakeholders, we will create a more secure pharmaceutical supply chain that will assure the continued distribution of safe prescription drugs for the benefit of public health.

• On Monday, the FDA announced the availability of a Small Entity Compliance Guide (SECG) to help explain the actions a small entity must take to comply with recent changes made to "Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt." The final rule, which was published on June 11, 2021 and modified on December 15, 2022 and April 14, 2023, amends and modernizes the standard of identity for yogurt by allowing for technological advances in yogurt production while preserving the basic nature and essential characteristics of yogurt.

• On Monday, the FDA announced its withdrawal as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA will continue its outreach to global partners and its efforts to ensure alignment of medical device international harmonization by primarily working with the International Medical Device Regulators Forum (IMDRF). In 2024, the FDA, as chair of IMDRF, will continue to work collaboratively to reach consensus on common goals, foster global regulatory convergence, and leverage resources to make safe and effective medical devices available globally.

• On Monday, the FDA approved nirogacestat (OGSIVEO, SpringWorks Therapeutics, Inc.) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors. Full prescribing information for OGSIVEO will be posted here.

• On Monday, the FDA issued another update to the Outbreak Advisory on the outbreak investigation of Listeria monocytogenes linked to peaches, plums, and nectarines (stone fruit). The advisory was updated to include the names of known retailers who received the recalled fruit including Publix, Wal-Mart & Sam's Club, Albertsons Company, ALDI, and Sprouts Farmers Market.

• On Wednesday, November 22, the FDA issued the final guidance "COVID-19: Developing Drugs and Biological Products for Treatment or Prevention." The guidance provides updated recommendations that reflect the evolving scientific knowledge and the current state of the pandemic. This supersedes the guidance of the same name initially issued on May 12, 2020, and reissued on February 22, 2021.

• On Wednesday, November 22, the FDA published the FDA Voices: "VAERS: A Critical Part of the National Vaccine Safety System," by Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research and Daniel Jernigan, M.D., MPH, Director of the National Center for Emerging and Zoonotic Infectious Diseases, CDC. VAERS is an early-warning monitoring system for vaccine safety. It allows patients, pharmaceutical companies, medical personnel and other users to report concerns about medical events that occurred after someone received a vaccination. VAERS has a proven track record of successfully helping to identify safety issues.

• On Wednesday, November 22, the FDA issued an update to the advisory for the Investigation of Elevated Lead Levels in Cinnamon Applesauce Puree. As of November 22, 2023, there have been 52 reports of adverse events potentially linked to recalled product submitted to FDA. To date, confirmed complainants are less than 1 to 4 years of age. The November 22 advisory stated that at the time, the FDA was aware that recalled WanaBana Apple Cinnamon Puree was still on the shelves at several Dollar Tree stores in multiple states. The FDA is working with the firm to ensure an effective recall. This product should not be available for sale and consumers should not purchase or consume this product as it is potentially contaminated with lead, which can be harmful to health, particularly for children. This investigation is ongoing and the FDA will update the advisory as information becomes available.

• On Tuesday, November 21, the FDA issued a Safety Alert to consumers not to eat, and restaurants and food retailers not to sell, and to dispose of oysters illegally harvested from Milford Approved area in Connecticut on 11/12/2023 and 11/15/2023 by original certified dealer Seaview Fisheries, CT-084-SS, AQ, and labeled as lots L466B and 466A because they may be contaminated. The oysters were directly distributed to a distributor in RI. Oysters were distributed further to a distributor and retailers in DE, FL, IL, MD, NJ, NY, PA, and TX and may have been distributed further from these states.

• On Tuesday, November 21, the FDA announced the ninth in the ongoing series of webinars exploring food safety culture will take place on December 6, 2023, from 12 noon to 1:00 pm ET. This webinar "Food Safety Culture: Storytelling to Shape, Reinforce, and Inspire" will focus on the importance of storytelling in building and reinforcing a strong food safety culture. The webinar series Collaborating on Culture in the New Era of Smarter Food Safety is in partnership with Stop Foodborne IllnessExternal Link Disclaimer, a non-profit public health organization.

 Additional Resources: 

• FDA Newsroom 

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration