{"id":47793,"date":"2025-09-16T10:15:51","date_gmt":"2025-09-16T10:15:51","guid":{"rendered":"https:\/\/site.itshrt.com\/worldnews\/weighing-the-benefits-and-risks-of-hormone-therapy-for-menopause-as-fda-considers-removing-black-box-warnings\/"},"modified":"2025-09-16T10:15:51","modified_gmt":"2025-09-16T10:15:51","slug":"weighing-the-benefits-and-risks-of-hormone-therapy-for-menopause-as-fda-considers-removing-black-box-warnings","status":"publish","type":"post","link":"https:\/\/site.itshrt.com\/worldnews\/weighing-the-benefits-and-risks-of-hormone-therapy-for-menopause-as-fda-considers-removing-black-box-warnings\/","title":{"rendered":"Weighing the benefits and risks of hormone therapy for menopause as FDA considers removing &#8220;black box&#8221; warnings"},"content":{"rendered":"<p> <script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<\/p>\n<div id=\"\">\n<p>Hot flashes and sleepless nights are just some of the symptoms of perimenopause that have been disrupting Isabel Kallman&#8217;s life.<\/p>\n<p>At 53 years old, Kallman&#8217;s hormones naturally started to decline, and the only medication available for her is menopause hormone therapy. For women experiencing the lead-up to menopause, hormone therapy treatment can involve using estrogen to help alleviate symptoms \u2014 but Kallman said she has been on the fence about it due to so-called &#8220;black box&#8221; labels on the medication, warning of the risk for stroke, blood clots, dementia and breast cancer.<\/p>\n<p>Kallman told CBS News she has been using &#8220;Fanny,&#8221; a handheld fan that she keeps in her bag to help with some of her symptoms. But now she&#8217;s considering hormone replacement as the Food and Drug Administration weighs removing some of the health warnings for <span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/news\/hormone-therapy-breast-cancer-risk-study\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">certain treatments<\/a><\/span>.<\/p>\n<p>Dr. Mary Rosser, who has been Kallman&#8217;s doctor for five years, said she believes flawed research from more than 20 years ago overstated the risks of breast cancer because it focused on older women.\u00a0<\/p>\n<p>&#8220;It&#8217;s been overblown,&#8221; Dr. Rosser, the director of Integrated Women&#8217;s Health at Columbia University Irving Medical Center\/NewYork-Presbyterian, told CBS News.<\/p>\n<p>The 2002\u00a0<span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/news\/shifting-world-of-womens-health\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">Women&#8217;s Health Initiative<\/a><\/span>, the largest long-term study on women&#8217;s health at the time, focused on older women who may not have started hormone replacement therapy until 10 or so years after going through\u00a0<span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/news\/menopause-grown-woman-talk-obgyn\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">menopause<\/a><\/span>.\u00a0<\/p>\n<p>The study, which raised safety concerns and led to a\u00a0<span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/news\/hormone-therapy-menopause-slow-aging\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">longtime public misunderstanding<\/a><\/span>\u00a0around hormone therapy, has since been found problematic in terms of how it was designed, according to Dr. C\u00e9line Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News. Now, health care professionals say factors such as age and dosing contribute to the safety of the treatment.<\/p>\n<p>More recent studies show that timing of treatment matters \u2014 a woman&#8217;s age when she begins menopause hormone therapy, along with the delivery method, can substantially mitigate risks, Gounder says.<\/p>\n<p>It&#8217;s &#8220;an example of [how] science evolves,&#8221; Gounder said of recent studies. Hormone therapy is the most effective treatment for a lot of perimenopausal symptoms, according to Gounder, who stressed that patients need to sit down with their doctors to determine what is right for them.<\/p>\n<p>Generally, treatment should start as close to the patient&#8217;s final menstrual period and continue until about the age of 60, Dr. Rosser says.<\/p>\n<p>&#8220;We have to look at your risk and calculate your risk score,&#8221; Dr. Rosser told Kallman.<\/p>\n<p>Dr. Rosser has spent the past nine months working through the <a href=\"https:\/\/www.cbsnews.com\/video\/study-shows-hormone-therapy-can-benefit-womens-health-during-menopause\/\" target=\"_blank\" rel=\"nofollow\" data-invalid-url-rewritten-http=\"\">benefits<\/a> and risks with her patient, who has a family history of breast cancer. While Kallman said she&#8217;s still hesitant, she realizes hormone therapy may be her best chance at relief.\u00a0<\/p>\n<p>&#8220;I&#8217;m hoping that there is an opportunity for me to do it,&#8221; Kallman told CBS News, adding that she hopes there&#8217;s an option that will help her in the short term.<\/p>\n<p>One type of treatment is low-dose vaginal estrogen therapy. Others include whole-body therapy like <span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/news\/pill-hot-flashes-women-menopause\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">pills<\/a><\/span>, patches, sprays, gels or a vaginal ring that deliver doses of hormones into the bloodstream at levels high enough to have significant effects on symptoms such as hot flashes.<\/p>\n<p>As experts like Dr. Rosser continue to have conversations about how to present the treatment&#8217;s pros and cons, an FDA-assembled panel has stressed the benefits and suggested health warnings be removed from at least some versions. However, dozens of experts called for more input before making any changes.<\/p>\n<p>A letter signed by 76 doctors and researchers argues that &#8220;removing label warnings without adequate scientific assessment puts patients at risk,&#8221; The Associated Press reported. The group asked the FDA to hold an advisory committee meeting with a public hearing before making any changes.<\/p>\n<p>Dr. Rosser said she sees it as a step in the right direction.\u00a0<\/p>\n<p>&#8220;This is a public health priority, and this is a sign that the FDA sees that,&#8221; she told CBS News.<\/p>\n<p>    <!-- data-recirc-source=\"queryly\" --><\/p>\n<aside class=\"component list recirculation component--type-recirculation \">\n<p><h3 class=\"component__title\">More from CBS News<\/h3>\n<\/p>\n<\/aside>\n<p>    <!-- tags --><\/p>\n<div class=\"content-author\">\n      <a href=\"https:\/\/www.cbsnews.com\/team\/nikki-battiste\/\" class=\"content-author__name\" data-invalid-url-rewritten-http=\"\">Nikki  Battiste<\/a><\/p>\n<div class=\"content-author__bio\">\n<div class=\"content-author__full-information\">\n<p class=\"content-author__text\">Nikki Battiste is a CBS News national correspondent based in New York. She is an Emmy and Peabody-award winning journalist, and her reporting appears across all CBS News broadcasts and platforms.<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<p><script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<br \/><a href=\"https:\/\/www.cbsnews.com\/news\/hrt-for-menopause-risks-benefits-fda-black-box-warnings\/\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Hot flashes and sleepless nights are just some of the symptoms of perimenopause that have been disrupting Isabel Kallman&#8217;s life.<\/p>\n","protected":false},"author":1,"featured_media":47794,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[32],"tags":[3642],"class_list":["post-47793","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-top-stories","tag-menopause"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Weighing the benefits and risks of hormone therapy for menopause as FDA considers removing &quot;black box&quot; warnings - World News<\/title>\n<meta name=\"description\" content=\"Research on hormone therapy for women going through menopause has changed over the past two decades. 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