By Sumathi Reddy
A longevity drug for women, or a danger to their health? Menopausal hormone therapy has been touted as both and everything in between.
The past week's government announcement calling for the removal of a black-box warning from all forms of hormone therapy was big news for women. On social media, there were virtual celebrations from influencers and doctors. But some longtime researchers have concerns the move was too quick, unclear and could prove harmful.
Menopausal hormone therapy, or hormone replacement therapy, as it is also called, was once commonly prescribed to combat declining estrogen levels in middle-aged women. Its popularity plummeted in 2003 when the government-funded Women's Health Initiative trial was abruptly halted because of signs it caused an increased risk of blood clots, stroke, and breast cancer.
The risks were largely concentrated among older, postmenopausal women. But the findings were applied across the board, resulting in prescriptions dropping to just 5% of women by 2020.
The Food and Drug Administration's recent announcement left many women with questions over who should be taking hormone therapy, when and why. Here's a breakdown.
What is local estrogen?
Across the board, doctors and researchers believe removing the black-box warning from local estrogen products is long overdue.
Local estrogen therapy typically involves applying a topical, low-dose estrogen to the vaginal area to treat genitourinary symptoms of menopause such as vaginal dryness as well as recurrent urinary tract infections.
About 70% to 80% of postmenopausal women experience urinary tract and vaginal symptoms that are lifelong and get progressively worse, says Dr. Lauren Streicher, clinical professor at Northwestern University's Feinberg School of Medicine.
A significant percentage of women given a prescription for local estrogen read the black-box warning and decide not to take it.
"For local vaginal estrogen that label was never appropriate in the first place," Streicher says.
Local estrogen results in minimal absorption into the bloodstream. So it is considered safe for women of all ages, including former breast-cancer patients.
What is systemic estrogen?
Systemic estrogen is used to treat a wider array of menopausal symptoms, and results in estrogen circulating throughout the bloodstream. It typically consists of taking estradiol -- delivered through pills, patches, gels and sprays -- often given in combination with oral progesterone to reduce the risk of uterine cancer.
Hormone therapy is approved for the treatment of hot flashes, night sweats and bone loss. It is often prescribed off-label for other symptoms.
When weighing potential benefits, it's important to determine whether the symptoms are related to menopause, says Stephanie Faubion, medical director of the Menopause Society and director of the Mayo Clinic Center for Women's Health.
"Would I start hormone therapy just for joint aches, no," she says. "Would I start it for mood-related symptoms? It depends on if it really seems to be hormonally related mood symptoms and do they have other symptoms. Most of the time these symptoms don't happen alone."
"We have to be very careful to not attribute all symptoms that occur in midlife to menopause and perimenopause," she adds.
Why was the decision to remove the black-box label from systemic estrogen controversial?
Most doctors agree hormone therapy has been underused as a treatment. But some believe the FDA went too far in removing the black-box warning from all forms and that a more thorough evaluation should have been conducted.
Not every type of systemic estrogen comes with the same risks. Oral estrogen, for example, has an increased risk of blood clots. Conjugated equine estrogen -- made from the urine of horses and used in the WHI study -- decreases breast-cancer risk in postmenopausal women when used without progesterone.
"Every one of these estrogen products has very specific risks, very specific benefits," Streicher says. "And instead of class labeling what we really need is product-specific labels."
Others like Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, said while the step won't change the guidance he has been giving patients for decades, it should help keep women from being unnecessarily alarmed.
"I think many of us believe the black-box warning may have been an overreaction to a study that was flawed," says Fleischman. "It doesn't mean that everyone should take hormone replacement therapy. The risks still exist but the black-box warning put an extra level of fear in women."
Who should take systemic estrogen?
Women who have symptoms in the years before and after reaching menopause should speak to their clinician about the benefits and risks of hormone therapy.
The best time to initiate hormone therapy is around the time of menopause, says Faubion.
Women who want to start taking it when they are 60 and over will likely not benefit and may incur health risks. They are generally advised against it.
Time since menopause may be a more important factor than biological age, says Faubion.
The average age women reach menopause -- defined as a year since your last natural period -- is 51, but there can be wide variation, she notes.
Government officials alluded to potential longevity benefits for women taking hormone therapy, such as a decreased risk of heart disease and cognitive decline. Some researchers think such comments were premature.
Studies looking at heart and cognitive health have produced mixed results. "Culturally, we want hormone therapy to be able to really solve all the issues that midlife women are facing, and no one medication can do that," says Dr. Rebecca Thurston, assistant dean for women's health research at the University of Pittsburgh.
Who shouldn't take systemic hormone therapy?
Besides older women and those more than 10 years postmenopause, several health conditions have contraindications to hormone therapy.
Women of any age with a history of heart attacks, stroke or severe liver disease are typically advised against initiating hormone therapy, Faubion says.
Those with a history of blood clots should have a discussion about the specifics of their condition to determine whether they are a good candidate, she says.
Women with a history of hormone-sensitive cancers and most types of breast cancer are also usually advised against taking hormone therapy.
Some breast-cancer doctors and advocates are worried about how the current messaging will affect their patients.
"These medications are not safe for our patients," says Dr. Shari Goldfarb, a breast oncologist at Memorial Sloan Kettering Cancer Center. "I worry that our patients are going to come in and want it, and it's going to increase breast-cancer recurrences and incidence of new primary breast cancers."
For women with a family history of breast cancer and other risk factors, clinicians will typically have a nuanced discussion to weigh the benefits and risks of the medication.
The bottom line: So, yes, concerns about the messaging of changing the label on hormone therapy are valid. And some touted benefits may be overblown. But increasing access to a treatment that could benefit millions of middle-aged women seems like a win for women's health.
Write to Sumathi Reddy at Sumathi.Reddy@wsj.com
(END) Dow Jones Newswires
November 16, 2025 09:00 ET (14:00 GMT)
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