{"id":369886,"date":"2025-11-10T19:55:12","date_gmt":"2025-11-10T19:55:12","guid":{"rendered":"https:\/\/www.europesays.com\/us\/369886\/"},"modified":"2025-11-10T19:55:12","modified_gmt":"2025-11-10T19:55:12","slug":"fda-removing-warning-from-hormone-based-menopause-drugs","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/369886\/","title":{"rendered":"FDA removing warning from hormone-based menopause drugs"},"content":{"rendered":"

WASHINGTON (AP) \u2014 Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia and other serious risks, the Food and Drug Administration<\/a> announced Monday.<\/p>\n

U.S. health officials said they will remove the boxed warning from more than 20 pills, patches and creams containing hormones like estrogen and progestin, which are approved to ease disruptive symptoms like night sweats.<\/p>\n

The change has been supported by some doctors \u2014 including FDA Commissioner Marty Makary<\/a>, who has called the current label outdated and unnecessary. But some doctors worried that the process that led to the decision was flawed.<\/p>\n

Health officials explained the move by pointing to studies suggesting hormone therapy<\/a> has few risks when started before age 60 or within 10 years of menopause symptoms.<\/p>\n

\u201cWe\u2019re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts,\u201d Health Secretary Robert F. Kennedy Jr.<\/a> said in introducing the update.<\/p>\n

The 22-year-old FDA warning advised doctors that hormone therapy can increase the risk of blood clots, heart problems and other health issues, citing data published more than 20 years ago.<\/p>\n

Many doctors \u2014 and pharmaceutical companies \u2014 have called for removing or revising the label, which they say discourages prescriptions and scares off women who could benefit.<\/p>\n

Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said the warnings have created a lot of hesitancy among patients.<\/p>\n

\u201cI can spend 30 minutes counseling someone about hormone-replacement therapy\u2014 tell them everything \u2014 but when they fill the prescription and see that warning they just get scared,\u201d Fleischman said.<\/p>\n

Other experts have opposed making changes to the label without a careful, transparent process<\/a>. They say the FDA should have convened its independent advisers to publicly consider any revisions.<\/p>\n

Medical guidelines generally recommend the drugs for a limited duration in younger women going through menopause who don\u2019t have complicating risks, such as breast cancer. FDA\u2019s updated prescribing information mostly matches that approach.<\/p>\n

But Makary and some other doctors have suggested that hormone therapy\u2019s benefits can go far beyond managing uncomfortable mid-life symptoms. Before becoming FDA commissioner, Makary dedicated a chapter of his most recent book to extolling the overall benefits of hormone therapy and criticizing doctors unwilling to prescribe it.<\/p>\n

On Monday he reiterated that viewpoint, citing figures suggesting hormone-therapy reduces heart disease, Alzheimer\u2019s and other age-related conditions.<\/p>\n

\u201cWith few exceptions, there may be no other medication in the modern era that can improve the health outcomes of women at a population level more than hormone replacement therapy,\u201d Makary told reporters.<\/p>\n

The veracity of those benefits remains the subject of ongoing research and debate\u2014 including among experts whose work led to the original warning.<\/p>\n

Dr. JoAnn Manson of Harvard Medical School said the evidence for overall health benefits is not \u201cas conclusive or definitive\u201d as what Makary described. Still, removing the warning is a good step because it could lead to physicians and patients making more personalized decisions, she said.<\/p>\n

\u201cThe black box is really one size fits all. It scares everyone away,\u201d Manson said. \u201cWithout the black box warning there may be more focus on the actual findings, how they differ by age and underlying health factors.\u201d<\/p>\n

In the 1990s, more than 1 in 4 U.S. women took estrogen alone or in combination with progestin on the assumption that \u2014 in addition to treating menopause \u2014 it would reduce rates of heart disease, dementia and other issues.<\/p>\n

But a landmark study of more than 26,000 women upended that idea, linking two different types of hormone pills to higher rates of stroke, blood clots, breast cancer and other serious risks. After the initial findings were published in 2002, prescriptions plummeted among women of all age groups, including those in earlier stages of menopause.<\/p>\n

Since then, all estrogen drugs have carried the FDA\u2019s boxed warning \u2014 the most serious type. <\/p>\n

\u201cThat study was misrepresented and created a fear machine that lingers to this day,\u201d Makary said.<\/p>\n

Continuing analysis has shown a more nuanced picture of the risks.<\/p>\n

A new analysis of the 2002 data published in September found that women in their 50s taking estrogen-based drugs faced no increased risk of heart problems, whereas women in their 70s did. The data was unclear for women in their 60s, and the authors advised caution.<\/p>\n

Additionally, many newer forms of the drugs have been introduced since the early 2000s, including vaginal creams and tablets that deliver lower hormone doses than pills, patches and other drugs that circulate throughout the bloodstream.<\/p>\n

The original language contained in the boxed warning will still be available to prescribers, but it will appear lower down on the label. The label will retain a boxed warning that women who have not had a hysterectomy should receive a combination of estrogen-progestin due to risks of cancer in the lining of the uterus.<\/p>\n

Hanging over Monday\u2019s announcement was the way the agency laid the groundwork for the decision.<\/p>\n

Rather than convening a standing advisory committees on women\u2019s health or drug safety, Makary earlier this year invited a dozen doctors and researchers who overwhelmingly supported the health benefits of hormone-replacement drugs.<\/p>\n

Many of the panelists invited to the July meeting consult for drugmakers or prescribe the medications in their private practices. Two of the experts also spoke at Monday\u2019s FDA news conference.<\/p>\n

Nearly 80 researchers later sent a letter to the FDA calling for an official advisory committee meeting.<\/p>\n

Diana Zuckerman of the nonprofit National Center for Health Research, which analyzes medical research, accused Makary of undermining the FDA\u2019s credibility by announcing the change \u201crather than having scientists scrutinize the research at an FDA scientific meeting.\u201d<\/p>\n

___<\/p>\n

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute\u2019s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. <\/p>\n","protected":false},"excerpt":{"rendered":"WASHINGTON (AP) \u2014 Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry…\n","protected":false},"author":3,"featured_media":369887,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[57,210,15817,1060,27989,15010,178456,15005,61,67,132,68,15649],"class_list":{"0":"post-369886","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health","8":"tag-general-news","9":"tag-health","10":"tag-marty-makary","11":"tag-medication","12":"tag-menopause","13":"tag-robert-f-kennedy-jr","14":"tag-steven-fleischman","15":"tag-u-s-food-and-drug-administration","16":"tag-u-s-news","17":"tag-united-states","18":"tag-unitedstates","19":"tag-us","20":"tag-womens-health"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/115527163935490183","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/369886","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=369886"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/369886\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/369887"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=369886"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=369886"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=369886"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}