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FDA approves life-extending pancreatic cancer drug Rasonque

FDA approves life-extending pancreatic cancer drug Rasonque

The drug, called Rasonque, is a once-daily pill for people with pancreatic cancer who've received prior treatment, or can't get combination therapy.

Case map and graphs capture resurgence of disease once eliminated in the US

Case map and graphs capture resurgence of disease once eliminated in the US

Graphics show how measles cases have surged to the highest level in decades

FDA Identifies Produce as Rapid Source of Listeria Contamination in Foodborne Illnesses

FDA Identifies Produce as Rapid Source of Listeria Contamination in Foodborne Illnesses

The U.S. Food and Drug Administration (FDA) has highlighted that produce isolates of *Listeria monocytogenes* are linked to a significantly shorter time frame for the detection of genetically related clinical illnesses compared to other food categories. A study analyzing 2,371 clinical and nonclinical *L. monocytogenes* isolates in New York from 2000–2021 revealed that 75% of produce isolates were genetically linked to clinical cases within 2.2 years. This contrasts sharply with other food categories, such as raw meat, where genetic links to clinical isolates could take up to 17 years to be detected. The research indicates that while *L. monocytogenes* is a leading cause of foodborne illness-related deaths in the United States, with an estimated 1,250 illnesses and 172 deaths annually between 2016–2019, produce appears to facilitate a more rapid progression from contamination to human illness. The study also examined the distribution of clonal complexes (CCs) of *L. monocytogenes* across various food categ...

Confirmed cyclospora cases surpass 17,000. See map of affected states

Confirmed cyclospora cases surpass 17,000. See map of affected states

Federal health officials are continuing to count cases of the diarrhea-causing parasite, which has now been confirmed in an additional state.

FDA Issues Urgent Recall for Multiple Cinnamon Brands Due to Toxic Lead Levels

FDA Issues Urgent Recall for Multiple Cinnamon Brands Due to Toxic Lead Levels

The U.S. Food and Drug Administration (FDA) has issued an urgent recall for several popular brands of ground cinnamon due to dangerously high levels of lead contamination. This recall affects specific lot codes of Marcum, Swad, Supreme Tradition, El Chilar, La Fiesta, and Valu Time ground cinnamon. Consumers are advised to immediately check their spice racks for these brands and specific lot numbers. Lead exposure, even in small amounts, can accumulate in the body and poses serious health risks, particularly for children and pregnant individuals. The FDA's alert emphasizes that the lead levels found in these products exceed safe consumption limits, likely due to contamination during harvesting or processing. The agency has provided a dedicated page on its official website for consumers to verify affected lot codes. If a lot code is not visible or the product is old, the safest course of action is to dispose of it.

FDA Proposes Mandatory GRAS Notification Requirements for Food Substances

FDA Proposes Mandatory GRAS Notification Requirements for Food Substances

The U.S. Food and Drug Administration (FDA) has initiated a 120-day consultation period on a proposed rule that would mandate the submission of Generally Recognized As Safe (GRAS) notices for substances used in human and animal food. This proposal aims to replace the current voluntary GRAS notification program with a mandatory system, requiring any entity introducing a substance into interstate commerce under the GRAS provision of the FD&C Act to notify the FDA. The goal is to enhance transparency and ensure that GRAS conclusions are supported by adequate scientific evidence and documentation. Key proposed changes include specifying circumstances where a GRAS notice is not required, identifying ineligible uses for GRAS notice submission, and updating regulations to reflect the transition to a mandatory program. The FDA also plans to revise the threshold of regulation (TOR) exemption framework to incorporate current scientific approaches and expand its scope.

Reddit Emerges as Early Warning System for Drug Harms, Study Finds

Reddit Emerges as Early Warning System for Drug Harms, Study Finds

A new study involving Penn LDI Senior Fellow Jeanmarie Perrone indicates that Reddit, one of the top 10 most visited websites in the U.S., can serve as an early warning system for identifying new drug trends and safety concerns. The social media platform, known for its community-driven forums called 'subreddits' that encourage anonymous discussion, offers insights into public discourse and cultural trends. Researchers utilized natural language processing to analyze Reddit posts from 2005-2024 concerning tianeptine products, often referred to as 'gas station heroin,' 'dope,' or 'zaza.' Tianeptine, an atypical antidepressant, is reportedly used to manage pain, opioid dependence, depression, or anxiety and is frequently sold in convenience stores, smoke shops, and online. The study observed a significant increase in posts mentioning tianeptine, rising from 1,555 in 2022 to 2,358 in 2023. Manual analysis of these posts revealed themes such as tianeptine dependence, withdrawal symptom management, and discussion...

Florida Experiences Surge in Unapproved Peptide Use Amidst Regulatory Concerns

Florida Experiences Surge in Unapproved Peptide Use Amidst Regulatory Concerns

Florida is currently experiencing a significant increase in the use of unapproved peptides, driven by social media influencers and wellness clinics. Thousands of Floridians are injecting these compounds, which are short chains of amino acids, despite a lack of FDA approval and robust safety data. These peptides are promoted for a wide range of benefits, including easing joint pain, weight loss, improved sleep, increased libido, and anti-aging effects. While some peptides, like insulin and certain GLP-1 drugs, are FDA-approved, many of the popular ones are synthesized in labs and sold through a 'gray market' or online vendors under the guise of 'for research use only.' This disclaimer allows sellers to bypass federal drug regulations, leading to concerns about product quality, purity, and potential health risks. Dr. Shan Siddiq, associate medical director at 10X Health’s Aventura wellness clinic, notes that while peptides have been used in medicine for years, their recent surge in popularity is largely due ...

Consumer Reports Identifies Widespread Label Inaccuracies in Prenatal Vitamins

Consumer Reports Identifies Widespread Label Inaccuracies in Prenatal Vitamins

Consumer Reports has released findings from its testing of 17 prenatal vitamin products, revealing significant inaccuracies between the nutrient levels stated on product labels and their actual contents. While the good news is that no safety concerns related to contaminants were found in any of the tested vitamins, only two out of the 17 products met industry-accepted potency ranges for every nutrient examined. These two products were Carlyle For Her Prenatal Multi-Vitamin & Mineral Formula and Bird&Be’s Complete Prenatal Pack. The investigation highlighted a lack of regulatory definition in the U.S. for what constitutes a prenatal vitamin or what specific nutrients it should contain. Despite these inaccuracies, Consumer Reports advises individuals not to stop taking their prenatal vitamins, as no safety issues were identified. They recommend looking for third-party verification seals like USP or NSF International and consulting with a healthcare provider before making any changes to supplement regimens.

GSK's Jemperli Receives Priority Review from FDA for Locally Advanced Rectal Cancer

GSK's Jemperli Receives Priority Review from FDA for Locally Advanced Rectal Cancer

The U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab), a drug developed by GSK. This application targets patients with previously untreated stage II and III mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer. The FDA has set a PDUFA action date for February 2027. The application is also eligible for expedited review through the National Priority Voucher program, potentially leading to an earlier FDA decision. This submission is supported by positive data from the registrational phase II, single-arm AZUR-1 trial, which demonstrated a significant and sustained clinical complete response rate for 12 months, meaning no detectable signs of cancer for at least one year. The safety profile of dostarlimab in this trial was consistent with its known and manageable safety profile observed in other solid tumors. Jemperli was previously granted Fast Track and Breakt...

Sprouts recalled after illnesses reported in 15 states. See products

Sprouts recalled after illnesses reported in 15 states. See products

The recalled products possibly connected to the outbreak were distributed to grocery stores and wholesale distributors in two states.

Alkermes' Alixorexton Shows Positive Results in Phase 2 Study for Narcolepsy Type 1

Alkermes' Alixorexton Shows Positive Results in Phase 2 Study for Narcolepsy Type 1

Alkermes plc announced the publication of data from its Vibrance-1 phase 2 study of alixorexton in adults with narcolepsy type 1 (NT1) in The Lancet Neurology. Alixorexton, an investigational oral, selective orexin 2 receptor (OX2R) agonist, demonstrated statistically significant and clinically meaningful improvements in wakefulness and cataplexy. The study, involving 92 adults with NT1, showed that once-daily alixorexton led to improvements in objective and subjective measures of excessive daytime sleepiness, as assessed by the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS). All tested dose groups (4 mg, 6 mg, and 8 mg) achieved mean sleep latency values within the normative range. Additionally, the 6 mg alixorexton group experienced a significant decrease in weekly cataplexy rate. The drug was generally well tolerated, with most treatment-emergent adverse events being mild to moderate in severity and no serious adverse events reported. These positive results have led Alkermes to...