FDA REMOVES BLACKBOX WARNING FROM ESTROGEN: (What does this mean)

FDA REMOVES BLACKBOX WARNING FROM ESTROGEN:

What does this mean? ~Dr. Erin Thorne, ND

The FDA recently removed the old black box warning from several hormone replacement therapy (HRT) products. The warning used to highlight risks like breast cancer, blood clots, and stroke. That warning was originally based on early interpretations of the Women’s Health Initiative (WHI), which we now know didn’t accurately reflect the risks for most women, especially younger women in perimenopause or early menopause.

So why was it removed?
Over the past 20+ years, the evidence has consistently shown that appropriately prescribed HRT — especially when started within 10 years of menopause — is not only safe for most women but can be incredibly beneficial (hot flashes, sleep, brain fog, bone health, heart health…the list is long). The FDA updated the labeling to better match what current research actually says.

But here’s the part I want you to really understand:
Removing the black box warning does not mean all hormones are equal, interchangeable, or risk-free.

Different forms of estrogen behave very differently in the body:

Estrogens (vaginal, topical vs oral)

1.) Vaginal estrogen
Extremely low dose, works locally, very minimal systemic absorption. Very low risk. This is the safest category and shouldn’t be lumped in with systemic HRT.

2.) Transdermal/topical estrogen (patches, gels)
Bypasses the liver, resulting in lower clot risk and a more steady hormone level. This is what many functional and integrative clinicians prefer for long-term use.

3.) Oral estrogen
Metabolized through the liver first. This increases clotting factors and can raise triglycerides. It’s not “bad,” but it carries a higher risk profile than transdermal options, especially for women with migraines, clotting risk, or metabolic concerns.

Progesterone vs. Progestins: This is where the WHI risks came from.

Bioidentical progesterone (micronized progesterone)

– Calming, can improve sleep and anxiety.
– Helps uterine protection without the same inflammatory or clotting risks seen with synthetic progestins.
– Not linked to increased breast-cancer risk in the research we have so far.

Progestins (synthetic versions used in older HRT products)

– Include medroxyprogesterone acetate — the “P” in Prempro.
– Different structure = different effects on the body.
– More likely to increase breast cell proliferation, inflammation, and clot risk.

So what did the WHI actually show?

This is the part that got misunderstood for years:

Estrogen + synthetic progestin (Prempro)
→ Small increased risk of breast cancer over several years.
→ More risk than estrogen alone.

Estrogen-only therapy (for women without a uterus)
→ Actually showed a lower risk of breast cancer compared to placebo.
→ And lower mortality.

So while the FDA’s move is a step forward, some of us in the hormone field feel it may have been a little premature, mainly because it could unintentionally make it seem like all estrogen therapies are equally safe or processed the same way, which simply isn’t the case.

What Im trying to say….
The black box removal is good news and reflects more accurate science — but it doesn’t replace the need for personalized hormone prescribing. Your age, symptoms, health history, route of administration, dose, and timing all still matter.

Estrogen Metabolism Testing

If you really want to use functional medicine to understand your risk factors when taking estrogen then using a urine or saliva estrogen metabolism testing.