FDA Is Removing the Black Box Warnings from Hormone Therapy Labels

In a move that’s already making waves across women’s health communities, the FDA is removing the black box warnings from hormone replacement therapies (HRT) used to treat menopause symptoms. After reviewing decades of research, the agency concluded that the alarming warnings — which linked hormone therapy to heart disease, breast cancer, and dementia — were based on flawed interpretations of older data.

The FDA will now work with drug companies to revise labels, removing unnecessary fear-driven warnings and replacing them with clearer, more balanced information that reflects current science.

What’s Changing — and Why

FDA Is Removing the Black Box Warnings

The change affects a wide range of hormone replacement options — from creams and pills to patches — designed to help women manage symptoms of menopause and perimenopause like hot flashes, night sweats, mood swings, and sleep issues.

Here’s what’s different:

• Removed Warnings: The FDA is taking out the black box warnings for cardiovascular disease, breast cancer, and dementia.
• Remaining Warning: One black box warning for endometrial cancer will remain for systemic estrogen-only products.
• Reason for Change: The agency acknowledged that previous studies misrepresented the actual risks, discouraging millions of women from using treatments that can significantly improve quality of life.

Dr. Marty Makary, a leading advocate for women’s health, explained that the decision was long overdue. “Women have been denied or never offered hormone replacement therapy despite the profound short- and long-term benefits,” he told NPR. “It’s time the science — not fear — leads the conversation.”

What This Means for Women

For years, menopause care has been clouded by stigma and misinformation. The FDA’s new decision opens the door to more transparent, evidence-based discussions between doctors and patients.

“The updated labels will help women and clinicians engage in shared decision-making, without an unnecessary barrier,” Makary said. “We’re moving away from blanket fear toward informed choice.”

Organizations like the American College of Obstetricians and Gynecologists (ACOG) have also applauded the decision, noting they’ve long encouraged the FDA to review warning labels for hormone therapies — especially low-dose vaginal estrogen products, which differ significantly from systemic options.

A Controversial Review Process

Despite widespread support, not everyone agrees with how the FDA handled the change. Some critics argue the agency’s July expert panel was too short and lacked the depth of traditional advisory committee meetings.

ACOG wrote in a formal statement, “While we appreciate the FDA Expert Panel’s interest, a brief two-hour session is no substitute for a full advisory committee process.”

Dr. Makary countered that the FDA’s new approach allows for faster, more adaptive decisions. “Traditional committees can be bureaucratic, slow, and costly,” he said. “Expert panels can still provide robust, data-driven discussions in a more efficient format.”

A New Chapter in Menopause Care

This historic shift is more than just a label change — it represents a transformation in how society views menopause and women’s health. Around 80% of women experience symptoms that can last an average of eight years, often with life-altering effects on mood, relationships, and well-being.

“For decades, women — including my own mother — were denied the life-changing benefits of hormone replacement therapy,” said Makary. “This change gives women back control over their health.”

The FDA is requesting that companies make changes to the labeling to provide current, accurate and balanced information about the benefits and risks of these drugs, so women, in consultation with their healthcare providers, can make the best decisions for their health.

Specifically, the agency is working with companies to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia. 

The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.

Though the starting time of HRT and duration of use are decisions made between the prescriber and the individual patient, the FDA’s labeled recommendation will be to start HRT within 10 years of menopause onset or before 60 years of age for systemic HRT.

This action follows the FDA’s assessment of the current relevant literature, including a reanalysis of data from younger cohorts of patients who initiated HRT within ten years of the onset of menopause.

The FDA recently approved a generic version of Premarin (conjugated estrogens) tablets, a complex mixture of estrogens used to treat various conditions related to menopause and hormone deficiencies.

The FDA has also approved non-hormonal medication for treating moderate to severe vasomotor symptoms, such as hot flashes.

About HRT

• HRT is FDA-approved for relief from common menopausal symptoms, such as hot flashes and night sweats (also known as vasomotor symptoms) and symptoms due to changes to the vagina, vulva, and urinary tract caused by decreased estrogen, also known as vulvovaginal atrophy or genitourinary syndrome of menopause. Some HRT products are also approved for the prevention of osteoporosis (bone weakening).

Why Ravoke Is Taking This Conversation Further

At Ravoke, this story underscores why we saw a vital need to expand the conversation around menopause — beyond headlines and policy changes — into real, human stories.

That’s why we’ve created a new TV series, filmed in Costa Rica, that brings together five women and leading experts to openly explore the challenges, myths, and breakthroughs surrounding menopause. The series, coming soon to Ravoke.com, dives into the emotional, physical, and spiritual aspects of this transformative stage of life — and how women are reclaiming their voices and power through it.

Learn more about the journey and our upcoming series here:
Four Days: A Life and Health Journey

Some Thoughts

The FDA is removing the black box warnings, but this change is only the beginning. For millions of women, it signals a new era of empowerment — one driven by science, openness, and shared understanding.

And at Ravoke, we’re proud to help lead that movement — one story, one woman, and one conversation at a time.