FDA Removes Black Box Warnings: What It Means for Hormone Therapy and Menopause Treatment

Staff of G. DeAn Strobel, MD, PA
5 days ago
2 min read

Big Changes to Hormone Therapy Safety Warnings

If you’ve been unsure about using hormone therapy for menopause, there’s good news. The FDA recently removed the black box warnings (the most serious safety label) from many hormone therapy products. This change is based on newer research showing that hormone therapy is much safer than we once thought, especially when started at the right time.

happy female patient — Happy female on hormone replacement

Why the Warnings Were Removed

Earlier studies, like the Women’s Health Initiative, included older women who started hormone therapy long after menopause. That’s not how most women use it today.

Now, we know that starting hormone therapy:

Before age 60, or
Within 10 years of menopause

can provide big benefits with fewer risks.

What Hormone Therapy Can Help With

Hormone therapy — especially bioidentical hormone therapy — can relieve:

Hot flashes
Night sweats
Vaginal dryness
Sleep problems
Mood swings
Bone loss

It may also help improve quality of life during and after menopause. This includes symptoms such as:

Fatigue
Mood swings
Brain fog
Joint pain
Sex drive
Weight gain
Memory and brain fog

Graphic describing removal of black box warning from hormone replacement — Talk to your doctor about hormones specific for your needs.

Safer, More Personalized Options

Not all hormone therapies are the same, and G. DeAn Strobel MD PA, we have know this and practice in this manner for many years.

You and your doctor can choose between:

Systemic therapy (pills, patches, creams/gels, and implants or pellets) — works throughout the body
Local/vaginal therapy (creams, tablets) — targets specific symptoms with lower risk (but without some of the benefits)

Plus, the old advice to “use the lowest dose for the shortest time” is gone. Treatment is now personalized based on your needs and health history.