The FDA Changed Its Warning. Does That Mean You Should Rethink Menopause Hormone Therapy?
Menopause can be a rough experience for many women: Maybe you’re noticing hot flashes, mood swings, or sudden changes with how your clothes are fitting and are trying to figure out what the heck is going on. You talk with your doctor and agree to start menopause hormone therapy. But when you pick it up, you read on the prescription label:
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA.
Uh, no thanks, Doc. You walk away, and continue to suffer. But at least you aren’t getting cancer, having a heart attack, or losing your mind, right?
Today, I want to talk about menopause hormone therapy (MHT). I want to address the FDA’s decision to remove this warning from estradiol products and why this is a good thing for both women and medical practitioners. I also want to address the many misconceptions as well as best use cases for MHT.
MHT and the Women’s Health Initiative: Where the Confusion Began
The Women’s Health Initiative (WHI) was a large-scale study in the 1990s investigating the impact of MHT for menopausal women in the prevention of cardiovascular disease and osteoporosis. It was stopped early (between 2002 and 2004) due to increased risks of breast cancer, cardiovascular disease, and dementia. This trial also coincided with the rapid growth of the 24-hour news cycle and the internet, fueling the spread of these results to millions of people.
As a result of the WHI, the FDA placed a black box warning on all estradiol products warning patients about the increased risks of cancer, heart disease, and dementia. And also as a result, many women came off MHT or refused MHT treatments despite ongoing menopausal symptoms.
Since the publication and rapid spread of these results, many of the researchers have worked for the next two decades to backtrack on some of these claims.
- Breast cancer risk went from 3 out of every 1,000 women to 4 out of every 1,000 women, an extremely small risk compared to what the headlines said.
- This increased cancer risk was NOT seen in the estradiol-only group but rather in the group that took estrogen + progestin, suggesting that progestin is the more likely culprit.
- Cardiovascular disease risk was only seen in women starting MHT later in life. Women starting MHT soon after menopause showed improved cardiovascular risk.
Why Did the FDA Remove the Black Box Warning?
Black box warnings are necessary to alert patients to the most serious side effects a medication can cause. But since medicine is a constantly evolving science, these warnings can quickly become outdated and inaccurate. The FDA decided to remove the black box warning from estradiol products for this very reason.
- We have better medication options for MHT and rarely prescribe the same synthetic hormones used in the study.
- Further studies have identified that MHT risk varies by age — the younger you are when you start, the less risk and more benefit.
- Black box warnings scare women away from treatments unnecessarily.
This is a change that has been long overdue, as many women have been inappropriately scared away from MHT due to this warning.
The Critical Window for Menopause Hormone Therapy
Follow-up studies to the WHI have shown that women who start MHT within 10 years of menopause have the least risk of adverse outcomes and the most benefits. The goal of MHT is to preserve estradiol signaling within the body for a longer period of time, thereby delaying issues with worsening cardiovascular disease, osteoporosis, and possibly dementia.
This time period between the onset of menopause and 10 years postmenopausal is often referred to as the “critical window” for initiation of MHT.
If someone has been in menopause for over 10 years, the lack of estrogen has already created adverse changes in the body — changes much harder to reverse in vascular plaque characteristics and bone structure, for example. Long-term studies support this, showing worsened cardiovascular outcomes if starting MHT later in life.
Does Menopause Hormone Therapy Cause Cancer?
At the time of this article, we have no randomized trial that definitively shows MHT causes breast cancer — or any cancer for that matter. We even have studies in women with a family history of breast cancer showing no increased cancer risk with MHT.
However, MHT can accelerate cancer once it is present, especially in estrogen- or progesterone-receptor positive breast cancers. These women must come off MHT immediately while undergoing breast cancer treatment.
Most women after breast cancer will not return to MHT, but there is evidence that MHT may be safe in some women post-breast cancer. That discussion is beyond the scope of this article.
Lastly, women who have a uterus must take estradiol AND progesterone, as we do know that estrogen-only therapy increases the risk of endometrial cancer.
Menopause and Its Impact on Long-Term Health
The perimenopause-to-menopause transition is riddled with health complications:
- Brain fog, hot flashes, and night sweats (neuroinflammation)
- Metabolic dysfunction and worsening cholesterol
- Increased midsection body fat
- Bone density decline
- Worsening depression and anxiety
- Decline in libido and self-esteem
Health Risks for Women Over 60
- Two-thirds of dementia cases are women
- Women’s heart attack risk increases in the 50s and equals men by the 60s
- Bone density significantly declines after age 60
While I cannot say MHT definitively prevents heart disease or dementia, it does improve risk factors that drive both — and optimizing risk factors is always a win.
What Are My Menopause Hormone Therapy Options?
Estradiol is available in three forms:
- Oral tablet
- Transdermal patch
- Compounded cream
Key Considerations
- Tablets and patches are usually covered by insurance; compounded creams are often not.
- Transdermal forms are considered safer than oral.
- Oral estrogen increases risk for blood clots, stroke, and liver strain.
- Adhesive sensitivity may make tablets preferable.
- Hormone-sensitive women often do better with creams.
Progesterone comes as capsules or compounded cream.
All women with a uterus must use progesterone with estradiol.
What About Bio-Identical Hormones?
“Bio-identical hormones” simply means the hormone molecule matches what the body naturally produces.
The estradiol in modern patches and pills is 17β-estradiol, identical to the body’s version.
Micronized progesterone mirrors natural progesterone.
In short: most modern MHT is now bio-identical.
My Clinical Framework for MHT
I discuss MHT daily with women in my practice. It is not one-size-fits-all — it’s tailored.
I strongly support MHT for women who:
- Notice major quality-of-life changes after menopause
- Have high dementia risk
- Have low bone density
- Suffer from severe hot flashes or night sweats
These are conditions that shape the rest of a woman’s life. If we can preserve function, increase healthspan, and reduce suffering — shouldn’t we?
The goal is not anti-aging.
The goal is function, independence, confidence, and vitality.
My hope is that now — without a terrifying black box warning — women can have more honest, informed conversations with their doctors about menopause hormone therapy.