FDA Removes Black Box Warning on Menopause Hormone Therapy: What That Means for You

When the U.S. Food and Drug Administration (FDA) announced plans to remove the black box warning—its most serious alert for prescription medications—on menopause hormone therapy (MHT) products, social media influencers took a victory lap. Their posts suggested MHT is good for everything—heart, brain, bones, even reversing the signs of aging.

“The removal of the black box lowers a barrier to appropriate care and reflects evolving evidence,” said Jessica Chan, MD, MSCE, a reproductive endocrinologist at Cedars-Sinai. “But it does not mean MHT is right for every woman in perimenopause or menopause.”  

Why Did MHT Warnings Change?

The FDA black box warning dates to the early 2000s when the Women’s Health Initiative (WHI) study sounded alarms about an increased risk of breast cancer, stroke and blood clots with certain formulations of hormone therapy. Since then, science has evolved and formulations have changed. Also, research has more clearly defined the risk-benefit differences between low-dose vaginal estrogen and systemic therapy, which circulates throughout the body.

The removal of the black box lowers a barrier to appropriate care and reflects evolving evidence. But it does not mean MHT is right for every woman in perimenopause or menopause.

Experts asked the FDA to reconsider the label, claiming the black box warning overestimated risk, deterred appropriate use and complicated insurance coverage.

“Removing the label helps us move beyond fear—especially for younger women who experience early or medical menopause—and into nuanced, individualized care,” Chan said.  

What the MHT Evidence Shows—and Doesn’t

The FDA ruling gives clinicians and patients space to individualize care, but it’s not a license to assume MHT is universally beneficial.

“The FDA’s action is progress, but it doesn’t mean MHT will solve every aging-related concern,” said Sharon Winer, MD, MPH, a reproductive endocrinologist at Cedars-Sinai. “There’s a lot we still don’t know.”

Here’s what the evidence does—and doesn’t—support:‍

• ‍Heart: Social media is swimming with posts claiming that MHT protects the heart, but the truth is more nuanced. Research suggests that women who have hot flashes, night sweats and other vasomotor (blood vessel-related) symptoms during the menopausal transition may benefit from MHT. However, according to Winer, “There’s no data to suggest that MHT prevents heart disease.”‍
• Brain: MHT may improve sleep and daytime functioning when it alleviates hot flashes and night sweats, but evidence regarding its long-term effects on cognition are mixed. “Hormones are not a treatment for dementia,” Chan said. ‍
• Bone: Estrogen helps maintain bone density and reduces fracture risk during treatment. “There’s even a very low-dose estrogen-only formulation called Menostar, which is designed to protect bones but without the risks of traditional MHT,” Winer said. Hormone therapy is not the only tool clinicians have to support bone health. Weight training, vitamin D, calcium and medications such as bisphosphonates can offer similar protection.

Formulation Matters

Since the WHI study data came out in 2002 and spurred hesitation around MHT, formulations have significantly changed. “Modern regimens favor estradiol—which is the same form of estrogen the ovaries produce—paired with micronized progesterone for women who have a uterus,” Winer said. “And clinicians often guide women toward transdermal delivery, such as patches and gels, which are absorbed through the skin and have a lower clot risk than oral pills.” (Micronized drugs are broken up into very fine particles for better absorption.)

The original black box warning also didn’t distinguish between local, vaginal estrogen and systemic therapy, which are strikingly different in terms of their risks and benefits.

• ‍Local treatments: Vaginal formulations include low-dose estrogen creams, rings and vaginal tablets designed to treat genitourinary syndrome of menopause—things like vaginal dryness, painful sex and recurrent urinary tract infections. “These products have very low systemic absorption,” said Chan. “Even breast cancer survivors, who typically shouldn’t get systemic therapy, could potentially use vaginal estrogen.” ‍
• Systemic therapy: Designed to treat hot flashes, night sweats and sleep disturbance, systemic hormone therapy options include transdermal formulations (patch or gel) as well as oral pills. Women who have a uterus must pair systemic estrogen with progesterone or progestin to protect the uterine lining.  

Whether you choose vaginal or systemic therapy, dosing and duration of MHT are important, too. “The conventional wisdom of ‘the lowest dose for the shortest amount of time’ has shifted to ‘the appropriate dose for the appropriate amount of time’—and all of that must be individualized,” Chan said.

For women who have been on hormone therapy for several years, clinicians may encourage tapering their use to see how they feel, since their needs may change as the body adapts to menopause.

Who Should Consider MHT—and Who Shouldn’t

When women reach menopause, levels of estrogen and progesterone plummet, causing symptoms like night sweats, hot flashes, and changes in mood and libido. While MHT may address some of those concerns, the benefits and risks of therapy differ based on myriad factors.

Key considerations include:

• ‍Timing: Women who are under 60, or within 10 years of their final menstrual period, are most likely to benefit from MHT. Starting later may be a reasonable option for some women, but it requires a thoughtful discussion about cardiovascular and clotting risks, since older women have a higher risk of complications.‍
• Symptoms: Troubling symptoms such as hot flashes and night sweats may signal impacts to the heart that may be addressed with MHT. But symptoms alone do not automatically warrant treatment. ‍
• Personal and family medical history: Women in early or surgical menopause should discuss MHT with their physicians. “For these women, the benefits are significant,” said Chan. On the flip side, breast cancer survivors and women with a family or personal history of hormone-driven cancers may not be candidates for systemic therapy.

Is MHT Right for You?

The removal of the black box warning is not a signal that every woman should start taking MHT no matter where they are in their menopause journey. It’s an invitation to have a discussion with your provider about your symptoms, medical history and long-term health goals.

“Estrogen is not a vitamin. It’s a prescription drug, so it requires a conversation with a skilled medical provider who is well versed in menopause medicine,” said Winer.

If menopause symptoms are disrupting your sleep, work or relationships, talk to your doctor about whether MHT may be a viable option for you. Together, you’ll create a plan—with hormones or without—that protects your long-term health while helping you feel like yourself again.

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