The Food and Drug Administration announced it will remove the black box safety warnings from estrogen-containing hormone therapies prescribed for menopause and perimenopause. Those warnings warned that these treatments could increase risks of certain cancers, dementia, heart attacks and strokes.
At a press conference Monday, FDA Commissioner Marty Makary said the agency is ending what he called a “fear machine” that steered women away from “life-changing, even lifesaving” treatment. He said the decision follows a review of recent scientific evidence and that the agency plans to replace the black box warnings with more nuanced information in packaging inserts so women receive better risk information.
Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), said the label changes should increase access and support shared decision-making between patients and clinicians. He noted, however, that ACOG’s guidance on estrogen therapy hasn’t changed and that systemic estrogen is not without risk; use should be individualized.
The FDA convened an expert panel in July and opened a public docket, receiving nearly 3,000 comments by the Sept. 24 deadline. ACOG’s formal comment encouraged reevaluation of warnings for low-dose vaginal estrogen but stressed that low-dose vaginal products and systemic estrogen therapies (pills, patches) are distinct and should be considered separately. ACOG also criticized the July expert panel as a brief substitute for a full advisory committee meeting and urged the FDA to hold separate advisory committee meetings with public engagement before making labeling decisions.
Makary said the agency chose expert panels over advisory committees because advisory committees can be bureaucratic, lengthy, expensive and sometimes conflicted. The FDA provided several studies it said support the change, citing older research that linked hormone therapy with reduced risks of Alzheimer’s disease, heart attack and hip fracture, plus an analysis suggesting that earlier initiation of hormone replacement therapy could save lives.
The debate over hormone therapy dates to a 2002 report from the Women’s Health Initiative that associated treatment with higher risks of cancer and stroke. Since then, additional research has suggested those risks were overstated and that starting therapy earlier may reduce cardiovascular risk for some women.
Makary argued many women were denied therapy after the 2002 findings, saying “fifty million women since that study 23 years ago have been denied or never offered or talked out of the life changing lifesaving benefits of hormone replacement therapy,” and noting that medical education often downplays menopause. He said symptoms affect over 80% of women, last on average eight years, and can be severe and debilitating, including mood swings, night sweats, weight gain and hot flashes.
ACOG reiterated that systemic estrogen has risks that must be weighed individually and maintained that more thorough FDA advisory processes would better ensure transparency and public input before broad labeling changes. The FDA, however, is moving forward with the label revisions based on its review and expert panels.