The FDA removes a long- standing warning from hormone-based menopause drugs

[Sarah B ✅]

Title:  The FDA removes a long- standing warning from hormone-based menopause drugs
Link To: Article 🔗 [Link: apnews.com/article/menopause-​hormones-​warning-​fda-​drugs-​pills-​women-​f26a8208fd3f5174ec96d61140439561/]
Author: Matthew Perrone
Date: 10 November 2025
"We're challenging outdated thinking and recommitting to evidence‑based medicine that empowers rather than restricts," Health Secretary Robert F.  Kennedy Jr.

"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."

"The 22‑year‑old FDA warning advised doctors that hormone therapy increases the risk of blood clots, heart problems and other health issues, citing data from an influential study published more than 20 years ago."

"Many doctors — and pharmaceutical companies — have called for removing or revising the label, which they say discourages prescriptions and scares off women who could benefit."

"I can spend 30 minutes counseling someone about hormone‑replacement therapy— tell them everything — but when they fill the prescription and see that warning they just get scared," Dr.  Steven Fleischman.

"Health officials explained the move by pointing to studies suggesting hormone therapy has few risks when started before age 60 and within 10 years of menopause symptoms."

"With 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," FDA Commissioner Marty Makary.

"The veracity of those benefits remains the subject of ongoing research and debate... Dr.  JoAnn Manson of Harvard Medical School said the evidence for overall health benefits is not 'as conclusive or definitive' as what Makary described."

"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."

"Rather than convening one of FDA's standing advisory committees on women's health or drug safety, Makary earlier this year invited a dozen doctors and researchers who overwhelmingly supported the health benefits of hormone‑replacement drugs."
Best Wishes Always
Sarah B
Global Moderator

[Resmiranda]

Good. First time I picked up a estradiol prescription in person, the pharmacist looked at it, at me, and then insisted I listen to them explain about blood clots.

Wholly unnecessary. My Endo was unhappy on my behalf. Saving newbies the trouble, not to mention everyone else needing HRT, seems a real win.

[Lori Dee ✅]

I have been saying this for years.

Ever since the Women's Health Initiative study, people have freaked out about blood clots and cancers. I've spent all my transition time educating healthcare providers and encouraging them to read the latest studies. Most just don't have time, or won't bother.

In the WHI study, 53,000 women participated to determine whether "adding a synthetic progestin to Premarin would improve the cardiovascular health of post-menopausal women".
Not one of the participants was transgender. Most providers have stopped prescribing Premarin (horse estrogen) and prefer to use bioidentical hormones instead of synthetic progestins.

The blood clot risk is still real for those who have certain health risk factors. But it only applies to estrogen pills. As the pills get metabolized by the liver, the metabolites (leftovers) affect the coagulation of the blood. Studies have found that this risk is not present when using sublingual, patches, gels, or injectables.

Now, if we can get them to remove the incorrect warnings about bioidentical progesterone, we will be making progress. But at least we are moving forward.