{"id":7103,"date":"2025-11-10T15:07:59","date_gmt":"2025-11-10T21:07:59","guid":{"rendered":"https:\/\/westplexnews.com\/index.php\/2025\/11\/10\/fda-to-remove-black-box-warning-from-hormone-replacement-therapy-drugs-2\/"},"modified":"2025-11-10T15:07:59","modified_gmt":"2025-11-10T21:07:59","slug":"fda-to-remove-black-box-warning-from-hormone-replacement-therapy-drugs-2","status":"publish","type":"post","link":"https:\/\/westplexnews.com\/index.php\/2025\/11\/10\/fda-to-remove-black-box-warning-from-hormone-replacement-therapy-drugs-2\/","title":{"rendered":"FDA to remove black box warning from hormone replacement therapy drugs"},"content":{"rendered":"

\"Blister<\/p>\n

Blister packs of hormone replacement therapy medication. (Getty photos)<\/p>\n

WASHINGTON \u2014 The U.S. Food and Drug Administration announced Monday it plans to remove warnings from hormone replacement therapy drugs that can be used to address symptoms of menopause, saying the statements are no longer needed.\u00a0<\/p>\n

The black box warning, the strongest caution possible from the FDA, was added in the early 2000s after a study from the Women\u2019s Health Initiative<\/a> showed an uptick in rates of blood clots, breast cancer, heart attacks and strokes for women who used certain types of hormone replacement therapy.\u00a0<\/p>\n

FDA Commissioner Marty Makary said during\u00a0a press conference<\/a> the change for estrogen-related products \u201cis based on a robust review of the latest scientific evidence.\u201d<\/p>\n

Makary rebuked the medical establishment for not putting enough effort into researching women\u2019s health conditions, including menopause.\u00a0<\/p>\n

\u201cA male-dominated medical profession, let\u2019s be honest, has minimized the symptoms of menopause, and as a result, women\u2019s health issues have not received the attention that they deserve. More than 80% of women have notable severe symptoms lasting up to eight years. How could the medical establishment get it so wrong for so long?\u201d Makary said. \u201cWomen deserve the same rigorous sciences as is used for men.\u201d<\/p>\n

Study criticized<\/h4>\n

Department of Health and Human Services Advanced Research Projects Agency for Health Director Alicia Jackson said the black box warning on estrogen was based on \u201cthe flawed, overgeneralized and misinterpreted WHI study.\u201d\u00a0<\/p>\n

Jackson said menopause leads to a series of complicated and often painful experiences for women, including \u201csleepless nights, derailed careers, painful sex, broken bones and a loss of wellbeing.\u201d<\/p>\n

Jackson explained that when the level of estrogen drops throughout and after menopause, \u201ca cascade of disease and aging begins.\u201d<\/p>\n

\u201cA preponderance of data now shows that estrogen, when started early, acts as a protective shield for the brain, lowering risks of memory loss, mental health decline and neurodegenerative disease, even Alzheimer\u2019s,\u201d Jackson said.\u00a0\u00a0<\/p>\n

Makary said women should talk with their doctors and can request their estrogen levels be monitored as they approach the age where menopause typically begins and throughout that years-long process.\u00a0<\/p>\n

He said that sometimes doctors can prescribe microdosing for hormone replacement therapy, followed by a half-dose and eventually a full dose as a woman\u2019s estrogen levels decrease over time.\u00a0<\/p>\n

Makary didn\u2019t say how many of the companies that produce hormone replacement therapies plan to remove the black box warning but said he expects nearly all will do so.\u00a0<\/p>\n

\u201cCompanies are, generally speaking, very excited when the FDA tells them they can remove a scary warning on your product,\u201d he said.\u00a0<\/p>\n

Review by panel<\/h4>\n

The FDA\u2019s process for removing the black box warning requirement, Makary said, began with an expert panel earlier this year. The FDA\u2019s subject-matter experts then conducted a \u201ccomprehensive review of the literature\u201d and recommended the agency remove the requirement, which Makary accepted.\u00a0<\/p>\n

The scientists who were part of the expert panel, he said, have written an article that will be published in the Journal of the American Medical Association.<\/p>\n

President of the American College of Obstetricians & Gynecologists Steven J. Fleischman wrote in a statement that he \u201ccommends the HHS leadership for improving the lives of perimenopausal women by making the estrogen products they need more accessible to them.\u201d<\/p>\n

\u201cThe modifications to certain warning labels for estrogen products are years in the making, reflecting the dedicated advocacy of physicians and patients across the country,\u201d Fleischman wrote. \u201cThe updated labels will better allow patients and clinicians to engage in a shared decision-making process, without an unnecessary barrier, when it comes to treatment of menopausal symptoms. ACOG has long advised clinicians to counsel patients based on an individual\u2019s unique risk factors and treatment goals; this announcement does not change ACOG\u2019s guidance on estrogen therapy.\u201d<\/p>","protected":false},"excerpt":{"rendered":"

Blister packs of hormone replacement therapy medication. (Getty photos) WASHINGTON \u2014 The U.S. Food and Drug Administration announced Monday it plans to remove warnings from hormone replacement therapy drugs that can be used to address symptoms of menopause, saying the statements are no longer needed.\u00a0 The black box warning, the strongest caution possible from the…<\/p>\n","protected":false},"author":2,"featured_media":7104,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_kadence_starter_templates_imported_post":false,"_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-7103","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\nFDA to remove black box warning from hormone replacement therapy drugs - WestplexNews.com<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/westplexnews.com\/index.php\/2025\/11\/10\/fda-to-remove-black-box-warning-from-hormone-replacement-therapy-drugs-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA to remove black box warning from hormone replacement therapy drugs - WestplexNews.com\" \/>\n<meta property=\"og:description\" content=\"Blister packs of hormone replacement therapy medication. 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