Veozah Label Update: Boxed Warning for Hepatotoxicity Added
The FDA has updated the prescribing information for Veozah (fezolinetant) to include a boxed warning for hepatotoxicity, following reports of serious liver injuries. This oral neurokinin 3 receptor antagonist is used to manage menopause-related vasomotor symptoms, such as hot flashes. Healthcare providers are now required to evaluate hepatic function before treatment and monitor liver health regularly to ensure patient safety.
Federal Court Orders FDA to Release Covid Vaccine Documents
A federal court ruling mandates the FDA to release additional Covid-19 vaccine documents, enhancing transparency around Pfizer-BioNTech’s emergency use authorization. This decision follows a lawsuit aimed at ensuring public access to critical health data, reflecting the growing demand for accountability in vaccine regulatory processes. The FDA must comply by June 2025, a move that could reshape public trust in health agencies amid ongoing pandemic challenges.
Kennedy’s Nomination Sparks Debate on Raw Milk Safety Amid Health Concerns
As the 2024 election season approaches, Robert F. Kennedy Jr.’s nomination as Secretary of Health and Human Services could significantly influence the raw milk movement in the U.S. While advocates see potential for growth, recent health concerns, including a recall linked to the H5N1 virus, raise alarms. Public health officials warn of the risks associated with unpasteurized milk, highlighting the ongoing debate over its safety and legality.
Low Uptake of Updated COVID-19 Vaccine Amid Holiday Season Concerns
A mobile medical station in New York City is facilitating access to the latest COVID-19 vaccine, yet only 20% of eligible Americans have received it. The CDC emphasizes that everyone aged 6 months and older qualifies for vaccination, which is crucial for preventing severe illness and long COVID. As the holiday season approaches, health experts urge individuals to consider vaccination to protect themselves and their communities.
FDA Issues Voluntary Recall of Duloxetine Due to Carcinogenic Impurities
The FDA has issued a voluntary recall of the antidepressant duloxetine due to carcinogenic impurities, specifically N-nitroso-duloxetine. Rising Pharmaceuticals initiated the recall affecting over 233,000 bottles, highlighting ongoing concerns about nitrosamine contamination in medications. Patients are advised to consult healthcare providers for guidance and alternative treatment options. Stay informed about medication safety and recalls to protect your health.
FDA Considers Ban on Red 3 Food Dye Amid Safety Concerns
The FDA is set to decide on a potential ban of Red 3, a food dye linked to health concerns, following a petition highlighting its safety. As scrutiny intensifies, especially with the holiday season approaching, lawmakers and health advocates are calling for stricter regulations on food additives. Stay informed about the implications of this decision on food safety and consumer health.
AAVantgarde Bio to Present Pioneering Gene Therapy Findings at FLORetina Annual Meeting
AAVantgarde Bio, a leading biotechnology firm in Italy, will present groundbreaking findings from its LUCE-1 clinical study at the FLORetina Annual Meeting on December 7, 2024. The study focuses on a novel dual AAV gene therapy for treating advanced retinitis pigmentosa due to Usher syndrome 1B, marking a significant advancement in ophthalmology. Prof. Francesca Simonelli will discuss the safety results from initial subjects, highlighting the potential of innovative gene therapies in inherited retinal disease treatment.
Calls for Reduced Mpox Testing Prices Amid Global Health Challenges
Global health advocates are urging Cepheid to reduce mpox test prices from $20 to $5, aiming to improve access in low-income countries like the Democratic Republic of Congo. Recent cases of mpox and bird flu in the U.S. highlight the urgent need for equitable healthcare solutions and enhanced disease surveillance. As the world faces these health challenges, the call for affordable testing and treatment options intensifies.
FDA Inspections Still Lag Behind Pre-Pandemic Levels, Raising Drug Safety Concerns
The FDA’s drug manufacturer inspections have not yet returned to pre-pandemic levels, raising concerns about drug safety and regulatory compliance. The Government Accountability Office highlights the need for enhanced inspection capabilities and workforce retention to ensure the safety of medications. As the agency navigates post-pandemic challenges, prioritizing foreign inspections is crucial for public health.
FDA Reports Alarming New Outbreaks of E. coli and Listeria
The FDA’s latest report reveals multiple outbreaks of E. coli O157:H7 and Listeria monocytogenes, with a significant outbreak linked to McDonald’s Quarter Pounder beef sandwiches causing 75 illnesses and one death. Taylor Farms has recalled silvered onions amid ongoing investigations. Health officials emphasize the importance of seeking medical attention for foodborne illness symptoms and highlight the availability of legal assistance for affected individuals.