Docs react to FDA’s removal of HRT black box warning: ‘An incredible mistake was made 25 years ago’—but not all agree

By MDLinx staffPublished November 12, 2025

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An incredible mistake was made 25 years ago... It's very hard not to argue that [it was] the greatest single failure of the modern medical system.

—Peter Attia, physician and longevity researcher, interview with 60 Minutes

The whole typical process was subverted with no transparency and no actual public commentary in the traditional way.

—Jen Gunter, MD

For years, the landscape of menopausal care has been haunted by the imposing presence of the black box warning that has loomed over hormone replacement therapy (HRT).^[] That warning—once a blunt instrument meant to signal elevated risks of cardiovascular disease, breast cancer, and dementia—is now being dismantled.

On November 10, 2025, the Food and Drug Administration (FDA), under direction from the US Department of Health and Human Services (HHS), announced the removal of the “boxed warning” label for many menopausal hormone therapies, which the FDA began adding in 2003. ^[]^[]

That regulatory shift is more than just a labeling change. It signals a broader reorientation in how we think about HRT—moving away from fear-driven caution toward a more nuanced, evidence-based dialogue about timing, patient selection, and benefit/risk calculus.

But while policy has pivoted, the real work lies in the exam room: Doctors are assessing, reacting, and reconsidering what this means for their patients now.

Docs react to the news

"That’s a huge shift finally some acknowledgment that the blanket fear around MHT wasn’t evidence-based for healthy women under 60. Hopefully this helps more clinicians feel comfortable offering it when appropriate," said Reddit user and physician @Lazy_Independent_172.

OB/GYN and minimally invasive gynecologic surgeon Karen Tang, MD, offers a similar perspective.

"This is an important step in removing unhelpful barriers—inaccurate barriers—to care, which allow for personalized, accurate counseling and talking to patients about their particular risk in their health goals," Dr. Tang said in a TikTok video.

She added that medication for women is always subjected to much more fear-based scrutiny than medication that affects only men.

"Everyone has heard about the risks of HRT ... but who can name a single risk of Viagra? And did you know that Viagra has been associated with an increased risk of melanoma in many studies? It can also cause blindness. But Viagra doesn't have a black box warning, and HRT did," she said.

In an interview with 60 Minutes, Peter Attia, a physician and longevity researcher, said, "An incredible mistake was made 25 years ago," when MHTs were labeled with the black box warning. "It's very hard not to argue that this is the greatest single failure of the modern medical system," he said.

And while OB/GYN Jen Gunter, MD, agrees with removing the black box warning from vaginal estrogen, she noted there was a lack of transparency about the process.

"The whole typical process was subverted, with no transparency and no actual public commentary in the traditional way," she said in an Instagram Reel. "The big issue, though, was the disinformation spewed by Kennedy and Makary about menopause hormone therapy being proven to reduce cardiovascular disease and dementia ... Makary basically said menopause kills women, menopause causes early death, and I'm like, Well, why are women living 10 years longer than men? I mean, you may as well say that not having menopause kills men. And it's that kind of twisting and cherry-picking and disinformation that does people a disservice."

Of course, not all docs think this is a step in the right direction. Two doctors on Reddit discussed implications that are likely top of mind for many physicians: @147zcbm123, an MD, asked "Does combined estrogen and progesterone not slightly increase the risk of breast cancer?" to which @Professional_Many_83, another MD, responded: "It does. And their messaging about it reducing cardiovascular disease is also bullshit, there’s no causative evidence linking HRT to decreasing cardiovascular risk."

Education refresher: What's changing

The FDA is requesting updates to the labeling of menopausal hormone therapies (MHTs), including both systemic and local vaginal products.^[] In the Boxed Warning—the agency’s most prominent safety notice—the FDA is asking for the removal of language related to cardiovascular disease, breast cancer, and probable dementia, as well as endometrial cancer, except for systemic estrogen-alone products. The recommendation to use the lowest effective dose for the shortest duration will also be removed, and the probable dementia warning will be eliminated throughout the labeling.

Additional changes differ by product type. For systemic MHTs, labeling will highlight consideration of starting therapy for moderate to severe vasomotor symptoms in women under 60 or within 10 years of menopause onset, and include relevant data from the Women’s Health Initiative for women aged 50–59.^[] The Boxed Warning for endometrial cancer (systemic estrogen-alone products) and information about cardiovascular disease and breast cancer will remain. For local vaginal estrogen products, the labeling will condense safety information and emphasize details most relevant to the local formulation.

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