**FDA to Remove Boxed Warning from Menopause Hormone Therapy Drugs**
WASHINGTON — 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 (FDA) announced Monday.
U.S. health officials will remove the boxed warning from more than 20 pills, patches, and creams containing hormones like estrogen and progestin. These medications are approved to ease disruptive menopause symptoms such as night sweats. The change has garnered support from some doctors, including FDA Commissioner Marty Makary, who called the existing label outdated and unnecessary. However, some experts are concerned that the process behind the decision lacked transparency.
**Updated Evidence, Updated Labels**
Health officials explained that recent studies suggest hormone therapy has few serious risks when started before age 60 or within 10 years of menopause onset.
“We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts,” Health Secretary Robert F. Kennedy Jr. said in announcing the update.
The FDA’s original boxed warning, introduced 22 years ago, alerted doctors that hormone therapy increases the risk of blood clots, heart issues, and other health problems, drawing on data from a landmark study published more than two decades ago. Since then, some medical societies and pharmaceutical companies have called for the warning to be updated, arguing it deters both doctors and patients.
**Impact on Patients and Prescribing Trends**
Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said the warnings have created unnecessary fear and hesitation among patients.
“I can spend 30 minutes counseling someone about hormone-replacement therapy, explain everything, but when they fill the prescription and see that warning they just get scared,” Fleischman said.
However, others argue that changes should have been made more transparently, ideally through consultations with the FDA’s independent advisory committees. Critics say skipping this process may undermine trust in the agency’s decision-making.
**Evolving Understanding of Hormone Therapy Risks and Benefits**
Most medical guidelines recommend hormone therapy for limited durations in younger women entering menopause who do not have complicating factors such as breast cancer. The FDA’s updated prescribing information is aligned with that advice.
Commissioner Makary and some doctors believe hormone therapy’s benefits may extend beyond managing symptoms. Before leading the FDA, Makary wrote extensively about the benefits of hormone therapy and criticized clinicians who are hesitant to prescribe it. On Monday, he reaffirmed his belief that hormone therapy can reduce risks of 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.
Not all experts agree. Dr. JoAnn Manson of Harvard Medical School, whose research contributed to the original warning, cautioned that the overall health benefits Makary described are not yet proven.
“Removing the warning is a good step because it could lead to physicians and patients making more personalized decisions,” Manson said. “The black box is really one size fits all. It scares everyone away. Without it, there may be more focus on the actual findings, how they differ by age and underlying health factors.”
**A Complex History: From Common Use to Caution**
In the 1990s, more than one in four U.S. women took estrogen alone or combined with progestin, based on the belief it would reduce rates of heart disease, dementia, and other issues in addition to treating menopause symptoms.
That changed in 2002, when a groundbreaking study of over 26,000 women linked hormone pills to higher rates of stroke, blood clots, breast cancer, and other serious risks. As a result, prescriptions for hormone therapy dropped sharply, even among younger menopausal women, and all estrogen drugs received the FDA’s most serious boxed warning.
“[The 2002] study was misrepresented and created a fear machine that lingers to this day,” Makary said.
Ongoing research has clarified that risks vary with age and health factors. A recent analysis published in September found that women in their 50s taking estrogen-based drugs faced no increased risk of heart problems, while women in their 70s did. The picture was less clear for women in their 60s, and researchers recommended caution.
Newer, lower-dose forms of hormone therapy — such as vaginal creams and tablets — have also been introduced since the early 2000s.
**What’s Changing with the Warning?**
While the original boxed warning language will still be available to prescribers, it will now appear lower down on the label. One key boxed warning will remain: Women who have not had a hysterectomy should receive a combination of estrogen and progestin to reduce the risk of uterine cancer.
**FDA Process Under Scrutiny**
The FDA sidestepped its usual public review process in making this decision. Rather than convening its standing advisory committees for women’s health and drug safety, Commissioner Makary invited a select group of doctors and researchers—most of whom support hormone therapy and many of whom consult for drugmakers or prescribe the medications themselves. Some of these panelists also spoke at the FDA’s news conference on Monday.
Asked why the FDA didn’t hold a formal advisory committee meeting, Makary responded that such meetings are “bureaucratic, long, often conflicted and very expensive.”
Diana Zuckerman, president of the nonprofit National Center for Health Research, criticized the move, saying it undermines FDA credibility: “Instead of having scientists scrutinize the research at an FDA scientific meeting, Makary announced the change himself.”
**The Future of Menopause Care**
The updated labeling is expected to help patients and doctors make more informed, individualized decisions about hormone therapy for menopause symptoms. As research continues, experts hope the conversation will use the best available evidence—balancing benefits and risks for each individual woman.
—
*The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.*
https://abc7.com/post/fda-removes-long-standing-warning-hrt-hormone-replacement-therapy-based-menopause-drugs/18139846/