{"id":12007,"date":"2020-06-03T17:35:07","date_gmt":"2020-06-03T21:35:07","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=12007"},"modified":"2020-10-12T15:07:34","modified_gmt":"2020-10-12T19:07:34","slug":"fda-approves-oriahnn","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/fda-approves-oriahnn\/","title":{"rendered":"FDA approves first oral medication for heavy bleeding from uterine fibroids"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">On Friday, May 29, the U.S. Food and Drug Administration (FDA) approved the first oral medication designed to treat the heavy premenstrual bleeding (menorrhagia) associated with uterine fibroids, a condition that causes tumors to grow along the uterine wall.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The medication, Oriahnn, is an estrogen and progestin combination product consisting of elagolix, estradiol, and norethindrone acetate. <\/span><a href=\"https:\/\/news.abbvie.com\/news\/press-releases\/fda-approves-first-oral-medication-for-management-heavy-menstrual-bleeding-due-to-uterine-fibroids-in-pre-menopausal-women.htm\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Manufactured by AbbVie<\/span><\/a><span style=\"font-weight: 400;\"> in conjunction with Neurocrine Biosciences Inc., these capsules are designed to address menorrhagia that fibroids can cause in <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/what-is-perimenopause\/\"><span style=\"font-weight: 400;\">premenopausal women<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Many women turn to surgery to address heavy bleeding, either in the form of a myomectomy to remove the fibroids or a hysterectomy to remove the entire uterus.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cAlthough surgical treatments, such as hysterectomy, are available, patients may not qualify for surgery or want the procedure,\u201d said Christine P. Nguyen, MD, Acting Director, Division of Urology, Obstetrics and Gynecology in FDA\u2019s Center for Drug Evaluation and Research, <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-new-option-treat-heavy-menstrual-bleeding-associated-fibroids-women\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">in a statement<\/span><\/a><span style=\"font-weight: 400;\">. \u201cVarious non-surgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA approved specifically for this use.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Shaili Gandhi, Pharm.D., vice president of formulary operations at SingleCare, notes that uterine fibroids can cause up to four times the amount of menstrual bleeding that a normal menstrual cycle would cause. The FDA approval of Oriahnn opens up another treatment option for women.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cOriahnn provides a non-invasive therapy that reduces the amount of bleeding and thereby, allowing a sense of normalcy,\u201d she says.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">By addressing the heavy bleeding issue, the medication may also help another side effect of fibroids in some women: <\/span><a href=\"https:\/\/www.hopkinsmedicine.org\/health\/conditions-and-diseases\/uterine-fibroids\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">iron-deficiency anemia<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/conditions\/anemia-treatment-and-medications\/\"><b>Anemia treatment and medications<\/b><\/a><\/p>\n<h2><b>Expanding the current treatments for fibroids<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Fibroids, which are also known as leiomyomas or myomas, affect more women than you might realize.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The Office on Women\u2019s Health estimates that somewhere <\/span><a href=\"https:\/\/www.womenshealth.gov\/a-z-topics\/uterine-fibroids#:~:text=About%2020%20percent%20to%2080,fibroids%20hard%20to%20live%20with.\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">between 20% and 80% of women<\/span><\/a><span style=\"font-weight: 400;\"> develop uterine fibroids by the time they turn 50 years of age. Age is definitely a factor; the closer a woman gets to menopause, the more likely that she is to develop these typically benign tumors. However, after menopause, the fibroids tend to shrink.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Not everyone with fibroids experiences severe bleeding, however. Women with mild symptoms often take low-dose birth control pills, and some opt for other birth control methods containing progesterone such as the injectable medication <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/depo-provera\"><span style=\"font-weight: 400;\">Depo-Provera<\/span><\/a><span style=\"font-weight: 400;\"> or <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/mirena-52-mg\"><span style=\"font-weight: 400;\">Mirena<\/span><\/a><span style=\"font-weight: 400;\">, an intrauterine device (IUD).\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Some women with mild to moderate symptoms take gonadotropin-releasing hormone agonists, like <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/lupron-depot-3-month\"><span style=\"font-weight: 400;\">Lupron<\/span><\/a><span style=\"font-weight: 400;\">, to shrink fibroids and reduce or even eliminate bleeding. However, the benefits of the agonists only last as long as you take the medication, and due to side effects like bone-thinning, experts recommend capping the length of time you take them at six months.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Oriahnn can also cause <\/span><a href=\"https:\/\/www.singlecare.com\/conditions\/osteoporosis-treatment-and-medications\/\"><span style=\"font-weight: 400;\">bone loss<\/span><\/a><span style=\"font-weight: 400;\"> over time, so the manufacturer cautions that a woman should not take this medication for more than 24 months. Regular bone scans are also recommended.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Other potential side effects include an increased likelihood of blood clots, heart attack, or stroke, especially in women over 35 who smoke or have certain conditions like high blood pressure, high cholesterol, diabetes, or obesity.\u00a0<\/span><\/p>\n<h2><b>When is Oriahnn available?<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">People who are interested in trying Oriahnn shouldn\u2019t have to wait much longer. The product should hit the pharmacy shelves very soon. AbbVie has announced that Oriahnn will be available to patients in the U.S. by the end of June. <\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On Friday, May 29, the U.S. Food and Drug Administration (FDA) approved the first oral medication designed to treat the heavy premenstrual bleeding (menorrhagia) associated with uterine fibroids, a condition that causes tumors to grow along the uterine wall.\u00a0 The medication, Oriahnn, is an estrogen and progestin combination product consisting of elagolix, estradiol, and norethindrone [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":6925,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4589,4114],"tags":[4141,8670],"coauthors":[9482],"class_list":["post-12007","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-info","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>Oriahnn: New FDA-approval for treatment of menorrhagia from uterine fibroids<\/title>\n<meta name=\"description\" content=\"An oral medication will soon be available to alleviate heavy menstrual bleeding (menorrhagia) from uterine fibroids, thanks to the FDA-approval of Oriahnn.\" \/>\n<meta name=\"robots\" content=\"index, follow, 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