Hormone Therapy for Menopause and the FDA Update: What It Means for You

If you’ve spotted the recent headlines about HHS and the FDA moving to remove the “black box” warning from certain menopause hormone therapy (MHT) medications, you’re not alone in wondering what this means for your health. Here’s a clear, up-to-date look at what’s changing—and why it matters.

What is a black box warning?

It’s the strongest safety warning the FDA places on a medication label—meant to signal serious risks that patients and clinicians should weigh before starting treatment.

Why did hormone therapy get this warning in the first place?

Back in 2003, early results from the Women’s Health Initiative (WHI) suggested higher rates of heart attack, stroke, blood clots, and breast cancer with hormone therapy. In response, the FDA added a black box warning to all estrogen-containing products, whether estrogen alone or estrogen with a progestogen.  Progestogens are given to a woman with a uterus who is taking estrogen to reduce the changes of endometrial (uterine) cancer.

What’s changed since then?

A lot. Two decades of research tell a more nuanced story:

• For healthy women who start MHT near menopause or before age 60, risks are far lower than originally believed.

• Short-term use (generally under five years) does not appear to raise breast cancer risk significantly for most women.

• Much of the risk seen in older studies came from older progestogens that are rarely used today.  (Women without a uterus don’t need a progestogen at all.)

So what is the FDA doing now?

After reviewing the more recent evidence—and hearing from experts and the public—the FDA is:

• Removing the black box warning on these medications (except the warning about endometrial cancer for estrogen-alone products).

• Updating the language on dosing and duration; the old “lowest dose for the shortest time” is no longer a universal rule.

• Clearing the way for more treatment options, including new generics that may reduce cost barriers.

Are the experts aligned?

Many women’s health leaders agree that labels should reflect current science. Some groups, including ACOG, have raised concerns about the process behind the changes, underscoring the importance of scientific transparency. But overall, there is strong support for updated labeling that aligns risk with the evidence.

Why do women choose hormone therapy?

• As estrogen and progesterone decline, MHT can provide meaningful relief from:

• Hot flashes and night sweats

• Sleep disruptions

• Vaginal dryness and painful sex

• Bone loss

Are there added benefits?

Starting MHT within 10 years of menopause (and before age 60) can reduce fracture risk and may also support heart and cognitive health for select women. The key is individualized assessment—your personal history and symptoms matter.

How can you take hormones?

Options include pills, patches, gels, sprays, and pellets. Each has pros and cons:

• Patches/gels: lower clot risk; gels can give variable dosing

• Pellets: may raise clot risk; dosing can be inconsistent

• Vaginal estrogen: safe for most women, even after breast cancer, when used in low doses for local symptoms

What if you’ve had breast cancer?

Systemic estrogen isn’t recommended, but low-dose vaginal estrogen is considered safe for most women managing dryness and urinary symptoms—even after treatment—when used under medical guidance.

What’s new on the market?

The FDA just approved the first generic version of Premarin (conjugated estrogens), which could make therapy more affordable. Non-hormonal options for hot flashes and night sweats are also expanding for women who can’t or prefer not to take hormones.

The bottom line: What should you do now?

Have a conversation with a clinician who understands menopause—ideally one certified by The Menopause Society. Your age, symptoms, medical risks, and personal preferences all shape the best path forward. With today’s broader range of safer, more personalized options, shared decision-making matters more than ever. Let your provider know what you’re experiencing and the results that you’re hoping for. You deserve care that meets your needs in midlife and beyond.

This information is provided for educational and informational purposes only and is not intended as medical advice. It should not be used to diagnose, treat, or replace the care of a qualified healthcare professional. Always consult your physician or other licensed medical provider with any questions or concerns about your health.