{"id":230821,"date":"2025-09-16T07:41:10","date_gmt":"2025-09-16T07:41:10","guid":{"rendered":"https:\/\/www.europesays.com\/us\/230821\/"},"modified":"2025-09-16T07:41:10","modified_gmt":"2025-09-16T07:41:10","slug":"weighing-the-benefits-and-risks-of-hormone-therapy-for-menopause-as-fda-considers-removing-black-box-warnings","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/230821\/","title":{"rendered":"Weighing the benefits and risks of hormone therapy for menopause as FDA considers removing &#8220;black box&#8221; warnings"},"content":{"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<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 <a href=\"https:\/\/www.cbsnews.com\/news\/hormone-therapy-breast-cancer-risk-study\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\" rel=\"noopener\">certain treatments<\/a>.<\/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<a href=\"https:\/\/www.cbsnews.com\/news\/shifting-world-of-womens-health\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\" rel=\"noopener\">Women&#8217;s Health Initiative<\/a>, 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<a href=\"https:\/\/www.cbsnews.com\/news\/menopause-grown-woman-talk-obgyn\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\" rel=\"noopener\">menopause<\/a>.\u00a0<\/p>\n<p>The study, which raised safety concerns and led to a\u00a0<a href=\"https:\/\/www.cbsnews.com\/news\/hormone-therapy-menopause-slow-aging\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\" rel=\"noopener\">longtime public misunderstanding<\/a>\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 noopener\" 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 <a href=\"https:\/\/www.cbsnews.com\/news\/pill-hot-flashes-women-menopause\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\" rel=\"noopener\">pills<\/a>, 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>\n        More from CBS News\n      <\/p>\n<p>      <a href=\"https:\/\/www.cbsnews.com\/team\/nikki-battiste\/\" class=\"content-author__name\" data-invalid-url-rewritten-http=\"\" target=\"_blank\" rel=\"noopener\">Nikki  Battiste<\/a><\/p>\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","protected":false},"excerpt":{"rendered":"Hot flashes and sleepless nights are just some of the symptoms of perimenopause that have been disrupting Isabel&hellip;\n","protected":false},"author":3,"featured_media":230822,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[210,27989,67,132,68],"class_list":{"0":"post-230821","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health","8":"tag-health","9":"tag-menopause","10":"tag-united-states","11":"tag-unitedstates","12":"tag-us"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/115212851050665331","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/230821","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=230821"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/230821\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/230822"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=230821"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=230821"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=230821"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}