Today, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders. The guidance, Stimulant Use Disorders: Developing Drugs for Treatment, when finalized, will be the first to provide the FDA’s current thinking on the overall development program and clinical trial design to develop drugs and biologics to support treatment of moderate to severe cocaine use disorder, methamphetamine use disorder and prescription stimulant use disorder.
“Currently there is no FDA-approved medication for stimulant use disorder. When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps,” said Marta Sokolowska, Ph.D., deputy center director for Substance Use and Behavioral Health in FDA’s Center for Drug Evaluation and Research. “The guidance is one of the actions within the agency’s Overdose Prevention Framework, which includes appropriate prescribing of prescription stimulants as well as development of evidence-based treatments for stimulant use disorder.”
Among other things, the draft guidance contains recommendations regarding clinical trial design related to evaluating stimulant use disorder treatments. Designing clinical studies to evaluate the safety and effectiveness of stimulant use disorder treatments presents a number of unique challenges—from selecting appropriate populations for studies to determining the most appropriate clinical endpoints—that require careful review. However, there are opportunities to improve clinical trial design and develop trials that are more person-centered, which may result in increased sensitivity to detect a treatment effect, with the potential for treatment effects to be linked to meaningful long-term outcomes.
The draft guidance also describes basic considerations throughout the drug development process including trial conduct, data collection, methods to assess treatment response, subject safety and new drug application requirements. For example, the guidance incorporates lessons learned about approaches that are unlikely to be successful and reflects current recommendations about approaches for treating stimulant use disorders and evaluating response to treatment.
Stimulant use disorder describes a range of symptoms associated with the use of stimulant drugs, including methamphetamine, cocaine, and amphetamines, but not including caffeine or nicotine. A diagnosis of stimulant use disorder is made when a clinician identifies a pattern of use of an amphetamine-type substance, cocaine, or other stimulant that leads to clinically significant impairment or distress, including an inability to reduce or control consumption, cravings to use a stimulant, continued use of a stimulant despite it causing negative consequences, and the need to use increased amounts of a stimulant to achieve the desired effect.
The agency has taken action to promote safe use and appropriate prescribing of prescription stimulants by requiring sponsors to update and standardize prescribing information for medications used to treat attention deficit/hyperactivity disorder (ADHD) and other disorders where stimulants are prescribed. Additionally, the FDA awarded the National Academies of Sciences, Engineering, and Medicine a grant to convene a workshop on the diagnosis and treatment of ADHD in adults. It has also funded several research projects to inform prevention of prescription stimulant misuse, addiction and overdose.
The FDA continues to encourage the development of treatments for stimulant use disorder and novel trial designs. Over the last several years, the agency has held workshops and public meetings with patients and patient advocates, researchers, industry and other stakeholder groups to better understand the stimulant use disorder landscape and inform the FDA’s understanding of the clinical context for drug review and regulatory decision making.
Salmonella Outbreak: Cantaloupe Recall Investigation
Salmonella outbreak: Cantaloupes recalled. Ongoing investigation. Stay informed for updates on the recall.
In recent weeks, an outbreak of Salmonella linked to cantaloupes has raised concerns across the United States and parts of Canada. The outbreak, which began in early November 2023, has resulted in numerous cases of illness reported from various states. Health authorities, including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), are diligently investigating this outbreak to identify the source of contamination and prevent further illnesses. This blog post aims to provide an overview of the outbreak investigation, affected products and stores, symptoms of Salmonella infection, and recommendations for consumers and businesses.
On November 22, 2023, Crown Jewels Produce, Sofia Produce, and CF Dallas initiated a recall of fresh cantaloupes and related products due to potential Salmonella contamination. As of November 24, CDC reported a total of 99 cases from 32 states, with the latest onset date being November 10, 2023. The investigation is still ongoing, as authorities are working to determine if additional products are linked to the illnesses. The FDA will provide updates on this situation as more information becomes available.
Affected Products and Stores:
The following brands of whole fresh cantaloupes have been recalled:
- Cantaloupes labeled “Malichita” or “Rudy,” with the numbers “4050” and “Product of Mexico/produit du Mexique.”
- These cantaloupes were sold in retail stores located in Arizona, California, Maryland, New Jersey, Tennessee, Illinois, Indiana, Kentucky, Michigan, Ohio, Oklahoma, Wisconsin, Texas, Florida, and Canada. It is important to note that this list may not include all states, as the cantaloupes could have reached consumers through further retail distribution.
Recalled cut cantaloupe and products made from the recalled whole cantaloupes include:
- ALDI’s cantaloupe, cut cantaloupe, and pineapple spears in clamshell packaging with Best-by dates between October 27 and October 31.
- Vinyard’s cantaloupe chunks and cubes, fruit mixes, melon medleys, and fruit cups containing cantaloupe. Most of these products have a “Vinyard” label, and some have a red label with “Fresh” sold between October 30 and November 10 in Oklahoma stores.
- Freshness Guaranteed seasonal blend, melon trio, melon mix, fruit blend, fruit bowl, seasonal fruit tray, fruit mix, and cantaloupe chunks. RaceTrac fruit medley sold in clear square or round plastic containers at select retail stores in Indiana, Michigan, Ohio, Kentucky, North Carolina, Tennessee, Virginia, Illinois, Texas, and Louisiana.
Symptoms of Salmonella Infection:
Salmonella infection typically manifests within 12 to 72 hours after consuming contaminated food and typically lasts for four to seven days. Common symptoms include diarrhea, fever, and abdominal cramps. It is important to note that severe infections are more likely to occur in children younger than five, the elderly, and individuals with weakened immune systems.
Status and Recommendations:
The investigation into the cantaloupe-related Salmonella outbreak is still ongoing. Authorities will continue to provide updates as new information becomes available. In the meantime, the following recommendations are crucial:
- Consumers, restaurants, retailers, and wholesalers should refrain from consuming, selling, or serving recalled cantaloupes or products containing cantaloupe.
- Those who have frozen cantaloupes for later use should check their freezers and discard any recalled fresh or cut cantaloupes.
- If you are unsure whether your cantaloupe is part of the recall, it is best to err on the side of caution and dispose of it.
- Retailers and wholesalers who received recalled whole melons should identify the boxes labeled “Malachita/Z Farms” or “Malichita” or “Rudy” from Crown Jewels Produce and Sofia Produce (TruFresh) and remove them from their inventory.
- It is crucial to follow FDA’s safe handling and cleaning advice, ensuring that any surfaces and containers that may have come in contact with the recalled products are thoroughly cleaned and sanitized to prevent cross-contamination.
- If you suspect you may be experiencing symptoms of a Salmonella infection after consuming recalled cantaloupes, it is essential to seek medical attention promptly.
The outbreak investigation of Salmonella linked to cantaloupes is a matter of concern, and authorities are actively working to protect public health. By staying informed, following the recommendations, and taking necessary precautions, we can collectively mitigate the risks associated with this outbreak. Stay tuned for updates and adhere to the guidance provided by health authorities to ensure the safety of yourself and your loved ones.
FDA Expands Cinnamon Applesauce Recall: Lead Contamination Concerns
FDA expands recall of cinnamon applesauce pouches due to lead contamination. Illnesses potentially linked to recalled product reported. Investigation ongoing.
In a recent development, the Food and Drug Administration (FDA) has issued an updated advisory regarding the investigation of elevated lead levels in cinnamon applesauce pouches. This update includes an expanded recall from WanaBana LLC, now encompassing Weis and Schnucks-brand cinnamon applesauce pouches. The move comes in response to growing concerns over potential health risks associated with lead contamination in these products.
Emerging Health Concerns:
As of November 13, 2023, the FDA has received 22 reports of illnesses that may be connected to the recalled cinnamon applesauce pouches. In light of this, the FDA is diligently assessing incoming adverse reports of related illnesses. Their investigation is ongoing, with a primary focus on identifying the source of lead contamination and determining whether additional products are also linked to these reported illnesses.
The FDA’s Commitment:
To ensure public safety, the FDA will continue to update this advisory as new information becomes available. This demonstrates their dedication to protecting consumers and their commitment to swift action when potential health risks are identified.
The expanded recall of cinnamon applesauce pouches serves as a stark reminder of the importance of rigorous product safety measures. It is crucial for consumers to stay informed and heed the FDA’s recommendations regarding recalled products. By working together, government agencies, manufacturers, and consumers can help maintain the highest standards of food safety, ultimately safeguarding the well-being of individuals and families across the nation. https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-parents-and-caregivers-not-buy-or-feed-wanabana-apple-cinnamon-fruit-puree-pouches?utm_medium=email&utm_source=govdelivery
FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases
Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications:
Adult patients with:
- moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
- active psoriatic arthritis;
- moderately to severely active Crohn’s disease; and
- moderately to severely active ulcerative colitis.
Pediatric patients 6 years of age and older with:
- moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and
- active psoriatic arthritis.
Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.
“Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” said Nikolay Nikolov, M.D., director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “Today’s approval could have a meaningful impact for patients managing their disease.”
Biological products include medications for treating many serious illnesses and chronic health conditions. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). An interchangeable biosimilar is a biosimilar that has been shown to meet other requirements under the law and may be substituted for the reference product without consulting the prescriber. The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” — similar to how generic drugs are substituted for brand name drugs.
All biological products are approved only after they meet the FDA’s rigorous approval standards. This means health care providers and patients can expect the same safety and effectiveness from both a biosimilar and an interchangeable biosimilar, just as they would for a reference product. Biosimilar and interchangeable biosimilar products may cost less than the brand-name medicine.
“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research. “This approval can empower patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”
The FDA’s approval of Wezlana is based on a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency (i.e., safety and effectiveness). This evidence included comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data. The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level.
Like Stelara, the most serious known side effect of Wezlana is infection. The most common adverse reactions with ustekinumab products are nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, influenza, fever and diarrhea.
The labeling for Wezlana, like Stelara, contains a warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization. There is also a warning that some malignancies, hypersensitivity reactions, and cases of Posterior Reversible Encephalopathy Syndrome have been reported in patients who received Wezlana in clinical studies. Wezlana must be dispensed with a patient Medication Guide that describes important information about its uses and risks.
The FDA granted the approval of Wezlana to Amgen, Inc.
- Information on Biosimilars for Patients and Health Care Providers
- Prescribing Biosimilars and Interchangeable Biosimilars
- Purple Book Database of Licensed Biological Products
Community9 months ago
Diana Gregory Talks to us about Diana Gregory’s Outreach Services
Senior Pickleball Report10 months ago
ACE PICKLEBALL CLUB TO DEBUT THEIR HIGHLY ANTICIPATED INDOOR PICKLEBALL FRANCHISES IN THE US, IN EARLY 2023
Entertainment11 months ago
The Absolute Most Comfortable Pickleball Shoe I’ve Ever Worn!
Blog10 months ago
Unique Experiences at the CitizenM
Automotive9 months ago
2023 Nissan Sentra pricing starts at $19,950
Senior Pickleball Report10 months ago
“THE PEOPLE’S CHOICE AWARDS OF PICKLEBALL” – VOTING OPEN
influencers9 months ago
Keeping Pickleball WEIRD, INEXPENSIVE and FUN? These GUYS are!
Blog11 months ago
Assistory Showing Support on Senior Assist Day