The Food and Drug Administration will remove a 22-year-old boxed warning from hormone-based menopause drugs.
More than 20 pills, patches, and creams containing estrogen and progestin will no longer carry bold labels about stroke, heart attack, and dementia risks.
The decision could reshape menopause treatment for millions of American women. FDA Commissioner Marty Makary called the current warnings outdated and unnecessary.
Health officials cited studies suggesting hormone therapy poses few risks when started before age 60. The therapy can also begin within 10 years of menopause symptoms.
“We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts,” Health Secretary Robert F. Kennedy Jr. said. Before the warning label, more than 1 in 20 American women took hormones, Kennedy noted.
Today, fewer than 1 in 20 use them. Many doctors and pharmaceutical companies have lobbied for years to remove the warning.
Other experts strongly opposed changing the label without proper review. They argue the FDA should have convened independent advisers to publicly consider revisions.
Current medical guidelines recommend limited hormone use for younger women without complications. FDA’s updated prescribing information largely aligns with this approach.
Makary went further, suggesting hormone therapy offers benefits beyond symptom relief. “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,” Makary told reporters.
The debate stems from a landmark 2002 study of 26,000 women. The research linked hormone pills to higher rates of stroke, blood clots, and breast cancer.
Prescriptions plummeted after those findings. All estrogen drugs have carried boxed warnings since then.
“That study was misrepresented and created a fear machine that lingers to this day,” Makary said. Recent analysis paints a more nuanced picture of the risks.
A September study found that women in their 50s taking estrogen faced no increased risk of heart disease. Women in their 70s did face higher risks.
Newer drug forms deliver lower hormone doses than earlier versions. Vaginal creams, rings, and tablets will receive separate labels reflecting their unique risk profiles.
The original warning language will remain in the prescribing information, but it will not be prominently displayed. Products will retain warnings about uterine cancer risks for certain women.
Critics questioned how the FDA reached this decision. Rather than convening standard advisory committees, Makary invited doctors who overwhelmingly supported hormone therapy benefits.
Many panelists at the July meeting consult for pharmaceutical companies or prescribe their medications. Some had ties to pharmaceutical campaigns lobbying for the removal of warnings.
Nearly 80 researchers sent the FDA a letter demanding an official advisory committee meeting. Diana Zuckerman of the National Center for Health Research accused Makary of undermining the FDA’s credibility.
The agency announced the change “rather than having scientists scrutinize the research at an FDA scientific meeting,” Zuckerman said. The decision marks a significant shift in federal guidance on menopause treatment.