The FDA removes a long-standing warning from hormone-based menopause
drugs
[November 11, 2025]
By MATTHEW PERRONE
WASHINGTON (AP) — Hormone-based drugs used to treat hot flashes and
other menopause symptoms will no longer carry a bold warning label about
stroke, heart attack, dementia and other serious risks, the Food and
Drug Administration announced Monday.
U.S. health officials said they will remove the boxed warning from more
than 20 pills, patches and creams containing hormones like estrogen and
progestin, which are approved to ease disruptive symptoms like night
sweats.
The change has been supported by some doctors — including FDA
Commissioner Marty Makary, who has called the current label outdated and
unnecessary. But some doctors worried that the process which led to the
decision was flawed.
Health officials explained the move by pointing to studies suggesting
hormone therapy has few risks when started before age 60 and 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“We’re challenging outdated thinking and recommitting to evidence-based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 in introducing the update.
The 22-year-old FDA warning advised doctors that hormone therapy
increases the risk of blood clots, heart problems and other health
issues, citing data from an influential study published more than 20
years ago.
Many doctors — and pharmaceutical companies — have called for removing
or revising the label, which they say discourages prescriptions and
scares off women who could benefit.
Dr. Steven Fleischman, president of the American College of
Obstetricians and Gynecologists, said the warnings have created a lot of
hesitancy among patients.
“I can spend 30 minutes counseling someone about hormone-replacement
therapy— tell them everything — but when they fill the prescription and
see that warning they just get scared,” Fleischman said.
Other experts have opposed making changes to the label without a
careful, transparent process. They say the FDA should have convened its
independent advisers to publicly consider any revisions.
Debate over the health benefits of hormone therapy continues
Medical guidelines generally recommend the drugs for a limited duration
in younger women going through menopause who don’t have complicating
risks, such as breast cancer. FDA’s updated prescribing information
mostly matches that approach.
But Makary and some other doctors have suggested that hormone therapy’s
benefits can go far beyond managing uncomfortable mid-life symptoms.
Before becoming FDA commissioner, Makary dedicated a chapter of his most
recent book to extolling the overall benefits of hormone therapy and
criticizing doctors unwilling to prescribe it.
On Monday he reiterated that viewpoint, citing figures suggesting
hormone-therapy reduces heart disease, Alzheimer’s and other age-related
conditions.
“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 veracity of those benefits remains the subject of ongoing research
and debate— including among the experts whose work led to the original
warning.
Dr. JoAnn Manson of Harvard Medical School said the evidence for overall
health benefits is not “as conclusive or definitive” as what Makary
described. Still, removing the warning is a good step because it could
lead to physicians and patients making more personalized decisions, she
said.
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Health and Human Services Secretary Robert F. Kennedy Jr. speaks
during an event about drug prices with President Donald Trump,
Thursday, Nov. 6, 2025, in the Oval Office of the White House in
Washington. (AP Photo/Evan Vucci)
 “The black box is really one size
fits all. It scares everyone away,” Manson said. “Without the black
box warning there may be more focus on the actual findings, how they
differ by age and underlying health factors.”
Hormone therapy was once the norm for American women
In the 1990s, more than 1 in 4 U.S. women took estrogen alone or in
combination with progestin on the assumption that — in addition to
treating menopause — it would reduce rates of heart disease,
dementia and other issues.
But a landmark study of more than 26,000 women challenged that idea,
linking two different types of hormone pills to higher rates of
stroke, blood clots, breast cancer and other serious risks. After
the initial findings were published in 2002, prescriptions plummeted
among women of all age groups, including younger menopausal women.
Since then, all estrogen drugs have carried the FDA’s boxed warning
— the most serious type.
“That study was misrepresented and created a fear machine that
lingers to this day,” Makary said.
Continuing analysis has shown a more nuanced picture of the risks.
A new analysis of the 2002 data published in September found that
women in their 50s taking estrogen-based drugs faced no increased
risk of heart problems, whereas women in their 70s did. The data was
unclear for women in their 60s, and the authors advised caution.
Additionally, many newer forms of the drugs have been introduced
since the early 2000s, including vaginal creams and tablets that
deliver lower hormone doses than pills, patches and other drugs that
circulate throughout the bloodstream.
The original language contained in the boxed warning will still be
available to prescribers, but it will appear lower down on the
label. The drugs will retain a boxed warning that women who have not
had a hysterectomy should receive a combination of
estrogen-progestin due to risks of cancer in the lining of the
uterus.
FDA sidestepped its usual public process in reviewing warning
Rather than convening one of FDA's standing advisory committees on
women’s health or drug safety, Makary earlier this year invited a
dozen doctors and researchers who overwhelmingly supported the
health benefits of hormone-replacement drugs.
Many of the panelists at the July meeting consult for drugmakers or
prescribe the medications in their private practices. Two of the
experts also spoke at Monday's FDA news conference.
Asked Monday why the FDA didn't convene a formal advisory panel on
the issue, Makary said such meetings are “bureaucratic, long, often
conflicted and very expensive.”
Diana Zuckerman of the nonprofit National Center for Health
Research, which analyzes medical research, accused Makary of
undermining the FDA’s credibility by announcing the change “rather
than having scientists scrutinize the research at an FDA scientific
meeting.”
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