SILVER SPRING, Md. /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.
“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in the FDA’s Center for Drug Evaluation and Research. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”
Menopause is a normal, natural change in a woman’s life when her period stops, usually occurring between ages 45 and 55. Menopause is often referred to as “the change of life” or “the change.” During menopause a woman’s body slowly produces less of the hormones estrogen and progesterone. A woman has reached menopause when she has not had a menstrual period for 12 consecutive months. Hot flashes occur in around 80% of menopausal women and can include periods of sweating, flushing and chills lasting for several minutes.
Some women who experience hot flashes and have a history of vaginal bleeding, stroke, heart attack, blood clots or liver disease, cannot take hormone therapies. Veozah is not a hormone. It targets the neural activity which causes hot flashes during menopause.
Patients taking Veozah should take one 45 milligram pill orally, once a day, with or without food. The pill should be taken at the same time each day. If a dose is missed, or not taken at the regular time, patients should take it as soon as possible and return to their regular schedule the following day.
The effectiveness of Veozah to treat moderate to severe hot flashes was demonstrated in each of the first 12-week, randomized, placebo-controlled, double-blind portions of two phase 3 clinical trials. In both trials, after the first 12 weeks, the women on placebo were then re-randomized to Veozah for a 40-week extension study to evaluate safety. Each trial ran a total of 52 weeks. The average age of the trial participants was 54 years old.
The prescribing information for Veozah includes a warning for elevated hepatic transaminase, or liver injury. Before using Veozah, patients should have blood work done to test for liver damage or infection. While on Veozah, routine bloodwork should be performed every three months for the first nine months of using the medication. Patients experiencing symptoms related to liver damage—such as nausea, vomiting, or yellowing of the skin and eyes—should contact a physician. Veozah cannot be used with CYP1A2 inhibitors. Patients with known cirrhosis, severe renal damage or end-stage renal disease should not take Veozah.
The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases.
The FDA granted the Veozah application Priority Review designation.
The approval of Veozah was granted to Astellas Pharma US, Inc.
- Menopause & Hormones Common Questions
- Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine-Division of Urology, Obstetrics, and Gynecology (DUOG)
SOURCE U.S. Food and Drug Administration
FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors
Today, the U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.
Desmoid tumors are non-cancerous but can be locally aggressive. The tumors may invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life. Although surgical removal has historically been the treatment of choice, there is a high risk that the tumor will return or that other health challenges will occur after removal; therefore, systemic therapies (cancer treatment targeting the entire body) are being increasingly evaluated in clinical trials.
“The FDA continues to address unmet medical need and advance the development of safe and effective therapies for the millions of Americans whose lives are affected by rare tumors,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Desmoid tumors are rare tumors that can lead to severe pain and disability. Today’s approval will offer the first approved treatment option for patients beyond surgery and radiation.”
The effectiveness of Ogsiveo was evaluated in an international, multicenter, randomized, double-blind, placebo-controlled trial in 142 adult patients with progressing desmoid tumors not amenable to surgery. Patients were randomized to receive 150 milligrams (mg) of Ogsiveo or placebo orally, twice daily, until disease progression or unacceptable toxicity. The main efficacy outcome measure was progression-free survival (the length of time after the start of treatment for which a person is alive and their cancer does not grow or spread). Objective response rate (a measure of tumor shrinkage) was an additional efficacy outcome measure.
The pivotal clinical trial demonstrated that Ogsiveo provided clinically meaningful and statistically significant improvement in progression-free survival compared to placebo. Additionally, the objective response rate was also statistically different between the two arms with a response rate of 41% in the Ogsiveo arm and 8% in the placebo arm. The progression-free survival results were also supported by an assessment of patient-reported pain favoring the Ogsiveo arm.
The most common side effects seen in at least 15% of the patients in the trial were diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection and dyspnea.
Ogsiveo was granted Priority Review under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition compared to available therapies. Ogsiveo also received FDA Fast Track and Breakthrough Therapy designations for the indication noted above, as well as Orphan-Drug designation for treatment of desmoid tumor (aggressive fibromatosis). Orphan-drug designation provides incentives to assist and encourage drug development for rare diseases.
The FDA granted the approval of Ogsiveo to SpringWorks Therapeutics Inc.
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
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