{"id":58551,"date":"2023-05-18T09:58:08","date_gmt":"2023-05-18T13:58:08","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=58551"},"modified":"2024-09-16T13:25:18","modified_gmt":"2024-09-16T17:25:18","slug":"fezolinetant-fda-approval","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/fezolinetant-fda-approval\/","title":{"rendered":"FDA approves novel drug for hot flashes"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">On Thursday, September 12, 2024, the <\/span><span style=\"font-weight: 400;\">FDA <\/span><a href=\"https:\/\/www.fda.gov\/safety\/medical-product-safety-information\/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">issued<\/span><span style=\"font-weight: 400;\"> a Drug Safety Communication warning<\/span><\/a><span style=\"font-weight: 400;\"> that <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/veozah\"><span style=\"font-weight: 400;\">Veozah (fezolinetant)<\/span><\/a><span style=\"font-weight: 400;\">, a medicine used to <\/span><span style=\"font-weight: 400;\">treat moderate to severe hot flashes caused by menopause<\/span><span style=\"font-weight: 400;\">, can cause rare but serious liver injury. The <\/span><span style=\"font-weight: 400;\">oral medication, manufactured by Astellas Pharma, was <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">FDA-approved<\/span><\/a><span style=\"font-weight: 400;\"> on May 12, 2023. Veozah is the first neurokinin 3 (NK3) receptor antagonist to receive approval for the treatment of vasomotor symptoms (hot flashes).\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Hot flashes are very common among people going through menopause. According to the FDA, about 80% of menopausal women experience vasomotor symptoms like hot flashes. And when they\u2019re frequent and severe, hot flashes and night sweats can take a serious toll on a person\u2019s quality of life\u2014which is why the approval of Veozah is important.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">However, individuals with signs of symptoms suggesting liver injury\u2014such as fatigue, nausea, vomiting, unusual itching, light-colored stools, jaundice (yellowing of the eyes or skin), dark urine, and abdominal pain or swelling are urged to discontinue the medication and seek medical advice from their healthcare provider.<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/menopause-diet\/\"><b>Menopause diet<\/b><\/a><b> | <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/menopause-questions-and-answers\/\"><b>Questions to ask your OBGYN about menopause<\/b><\/a><\/p>\n<h2><span style=\"font-weight: 400;\">How Veozah works<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Currently, hormone therapy is considered the most effective treatment available for this type of symptom, says Stephanie S. Faubion, MD, medical director for <\/span><a href=\"https:\/\/www.menopause.org\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">The North American Menopause Society<\/span><\/a><span style=\"font-weight: 400;\">. But hormone therapy isn\u2019t for everyone. Some people have a history of heart attack, stroke, blood clots, or breast cancer, among other health conditions, that might preclude them from using this treatment. For these individuals, Veozah may be a safer\u2014and still effective\u2014treatment option.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Veozah works by targeting the neural activity that causes hot flashes. Specifically, it works by \u201cbinding to and blocking the activities of the NK3 receptor, which plays a role in the brain\u2019s regulation of body temperature,\u201d according to the FDA. The NK3 receptors are found in the central nervous system and can trigger hot flashes.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The effectiveness of Veozah in addressing hot flashes was demonstrated in two phase 3 clinical trials that each ran for a total of 52 weeks.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">As yet, there have been no studies comparing Veozah to hormone therapy. \u201cIt does appear to be safe and effective and a great non-hormonal option,\u201d Dr. Faubion says.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Who can take Veozah?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Veozah comes with a warning for elevated liver enzymes (liver injury) from the FDA, which may disqualify some people from taking it. People who have cirrhosis or severe or end-stage renal disease should not take Veozah.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Patients will need to undergo blood work to test for liver damage before they can begin taking this medication. Additionally, people who take Veozah will need to undergo routine blood work every three months for the first nine months.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThe benefits outweigh the risks for the majority of healthy women who are under the age of 60 and within 10 years of menopause onset who need symptom relief,\u201d Dr. Faubion says. \u201cIt is wonderful to see a new treatment option for hot flashes and night sweats on the market. That women have more options is a good thing.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If you are currently taking Veozah or starting the medication, be sure to discuss concerns with your healthcare provider. They can help you assess the benefits versus risks and determine if the medication is right for you based on your health history, lifestyle, and medical conditions.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Veozah availability and cost<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Veozah is available in a 45 mg oral dose intended to be taken once daily, with or without food.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The average retail price of Veozah is $738.31 for 30, 45 mg tablets, but you can reduce the cost to about $539.90 using <\/span><a href=\"https:\/\/www.singlecare.com\/prescription-discount-card\"><span style=\"font-weight: 400;\">SingleCare\u2019s free prescription drug discount card<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On Thursday, September 12, 2024, the FDA issued a Drug Safety Communication warning that Veozah (fezolinetant), a medicine used to treat moderate to severe hot flashes caused by menopause, can cause rare but serious liver injury. The oral medication, manufactured by Astellas Pharma, was FDA-approved on May 12, 2023. Veozah is the first neurokinin 3 [&hellip;]<\/p>\n","protected":false},"author":135,"featured_media":6927,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4114],"tags":[4141,8670],"coauthors":[9482],"class_list":["post-58551","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-fda-approvals","tag-womens-health","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Fezolinetant FDA approval for hot flashes<\/title>\n<meta name=\"description\" content=\"The FDA approved Veozah (fezolinetant) for the treatment of hot flashes caused by menopause. 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