The U.S. Food and Drug Administration (FDA) has announced the removal of black box safety warnings from all hormone therapy treatments used to relieve menopause and perimenopause symptoms. These products include creams, pills, and patches containing estrogen or other related hormones.
Previously, the prominent warnings cautioned that such therapies might increase risks of certain cancers, dementia, heart attacks, and strokes. The decision marks a major shift in how the agency views hormone therapy, aiming to provide women with more balanced and accurate information.
FDA Commissioner: “Ending the fear machine”
During a Monday press conference, FDA Commissioner Marty Makary declared that the agency’s move was grounded in updated evidence: “The FDA today is announcing that we are going to stop the fear machine steering women away from this life-changing, even lifesaving treatment.”
Makary explained that instead of stark black box warnings, the FDA will now require nuanced risk explanations within package inserts to give patients more context. “The idea is to get better information in front of women,” he told NPR’s *All Things Considered*.
Doctors and medical organizations welcome the update
Dr. Steven Fleischman, president of the American College of Obstetrics and Gynecology (ACOG), supported the change, saying the updated labeling will enhance shared decision-making between patients and clinicians.
He emphasized that while ACOG’s official guidance remains unchanged, the new labels remove unnecessary barriers to care. “Like all medications, systemic estrogen products are not without risk, and their use should be based on an individualized conversation between patients and their clinicians,” Fleischman added.
Reevaluating decades of research and stigma
The FDA’s move follows a lengthy debate over the safety of hormone therapy. In 2002, the Women’s Health Initiative study linked hormone replacement therapy to higher risks of cancer and stroke. However, subsequent research has revealed that those risks were overstated—especially for women who begin treatment earlier—and that the therapy can lower heart disease risks.
“Fifty million women since that study have been denied or talked out of the life-changing, lifesaving benefits of hormone replacement therapy — including my mom,” Makary said. He also noted that menopause symptoms are more severe and longer-lasting than many doctors realize, with up to 80% of women affected for an average of eight years.
FDA process sparks debate among medical experts
Despite overall support for removing the warnings, some experts criticized the FDA’s process. The agency convened a brief expert panel in July rather than a full advisory committee meeting, which the ACOG argued was less rigorous.
In its formal comment, ACOG wrote, “A brief panel such as the two-hour July 17th Expert Panel should not be considered an adequate substitute for an advisory committee meeting.” The group urged the FDA to hold separate advisory meetings for low-dose vaginal estrogen and systemic hormone therapy, allowing for broader scientific and public engagement.
Scientific evidence underpinning the decision
The FDA cited multiple studies dating from the 1980s to early 2000s that demonstrated benefits of hormone therapy, including reduced risks of Alzheimer’s disease, heart attack, and hip fractures.
While the decision remains controversial, many medical professionals view it as a long-overdue correction that may improve the quality of life for millions of women experiencing menopausal symptoms.
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