“I saw that cancer warning in the papers that came with the prescription, so I never used it.”
For over 20 years, I heard this at least once a week.
A woman would come in with painful sex that started in menopause. Her doctor had prescribed vaginal estrogen years ago. But she never filled it—or filled it and threw it away—because of the terrifying black box warning on the package.
She suffered for years with a condition that could have been easily treated, all because of a misleading FDA warning.
In November 2025, that finally changed.
After decades of advocacy from women’s health experts, the FDA announced it would remove black box warnings from all estrogen products, including vaginal estrogen. The agency acknowledged that outdated warnings had scared millions of women away from safe, effective treatment.
But the damage has been done. An entire generation of women avoided treatment they needed because of warnings based on research that didn’t even apply to vaginal estrogen.
Here’s what actually happened, what the research shows, and what this historic change means for you.
The Scary Warning Label (And Why It’s There)
If you’ve ever looked at the package insert for vaginal estrogen, you’ve seen language like this:
“The Women’s Health Initiative (WHI) reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women…”
Heart attacks. Stroke. Breast cancer. Blood clots.
No wonder women are terrified.
Since 2003, all estrogen products—including low-dose vaginal estrogen—have been required to carry this black box warning. Black box warnings are reserved for the most dangerous medications with potentially life-threatening adverse effects.
But here’s what the warning doesn’t tell you: This research was about systemic hormone therapy, not vaginal estrogen. And it doesn’t apply to the low doses used for vaginal symptoms.
How We Got Here: The Women’s Health Initiative
Before 2001, hormone therapy (HT) was considered safe and beneficial. Doctors believed estrogen protected against heart disease and had minimal effect on breast cancer risk. HT was the #1 prescribed medication in America in the 1990s.
Then came the Women’s Health Initiative (WHI)—the first large randomized controlled trial of hormone therapy.
The study enrolled over 15,000 women to examine the effects of HT on cardiovascular disease, breast cancer, and other health outcomes. In 2001, researchers stopped the study early because they found increased risks of breast cancer and cardiovascular disease in women taking HT.
The announcement made front-page news. Women worldwide stopped taking hormones. Doctors stopped discussing menopause treatment. And the FDA mandated black box warnings on all estrogen products.
The problem: The WHI studied systemic hormone therapy—oral pills or patches designed to raise estrogen levels throughout the entire body.
It did not study low-dose vaginal estrogen.
Systemic vs. Vaginal Estrogen: A Critical Difference
Systemic hormone therapy (HT):
- Delivered via pills or patches
- Designed to raise estrogen levels throughout the body
- Used to treat hot flashes, night sweats, bone loss
- Higher doses
Low-dose vaginal estrogen:
- Delivered via creams, tablets, rings, or suppositories
- Applied directly to vaginal and vulvar tissue
- Used to treat vaginal dryness, painful sex, urinary symptoms
- Much lower doses
How much lower?
The average dose of vaginal estrogen is 10 mcg of estradiol, typically used twice weekly. An entire year’s supply equals 1 mg of estradiol—less than half the dose of one birth control pill.
There are even lower-dose versions available (4 mcg).
Does Vaginal Estrogen Get Into Your Bloodstream?
Yes. Medications applied to vaginal tissue do get absorbed into the bloodstream to some degree.
Research shows that estrogen levels rise transiently when vaginal estrogen is applied, but these levels don’t stay elevated above normal postmenopausal ranges.
The real question: Does this small, temporary increase cause the same risks as systemic hormone therapy?
What the Research Actually Shows
Fortunately, we have excellent data to answer this question.
The WHI included an observational component that tracked health outcomes for women using systemic HT or vaginal estrogen. Between 1992 and 2005, this study enrolled 93,676 postmenopausal women. About 4,200 used vaginal estrogen alone (without systemic HT). These women were followed for an average of 6-7 years.
The findings: Low-dose vaginal estrogen did not increase rates of cardiovascular disease, cancer, or blood clots.
A 2020 comprehensive review of all research on low-dose vaginal estrogen confirmed the same conclusion: it is effective and it is safe.
What About Women Who’ve Had Breast Cancer?
This is where things get especially important.
Women who’ve had breast cancer often undergo treatments that drastically lower estrogen levels to reduce cancer recurrence risk. These treatments can cause severe vaginal dryness and painful sex.
For years, the answer to “Can I use vaginal estrogen?” was an absolute, unequivocal NO.
That’s changing.
Multiple studies have found no increased breast cancer risk or recurrence in women using low-dose vaginal estrogen:
- The WHI observational study found no connection
- A large Finnish study found no connection
- Multiple smaller studies confirmed the same
In 2016, the American College of Obstetricians and Gynecologists (ACOG) stated: “The data do not show an increased recurrence among women currently undergoing treatment for breast cancer or those with a personal history of breast cancer who use vaginal estrogen to relieve urogenital symptoms.”
In 2020, the North American Menopause Society (NAMS) and the International Society for the Study of Women’s Sexual Health (ISSWSH) issued updated guidance:
First-line treatments for vaginal symptoms should be non-hormonal (moisturizers, lubricants, dilators). But if these don’t work, vaginal estrogen can be considered—even for women with breast cancer history.
This is a major shift based on accumulating evidence of safety.
Major Update: The FDA Finally Changed the Warning (November 2025)
For years, women’s health advocates fought to remove the misleading black box warning from vaginal estrogen.
In 2008, the North American Menopause Society petitioned the FDA to remove it. The FDA rejected the petition.
For over a decade, despite mounting evidence, the FDA refused to budge—maintaining that all estrogen products required the same dire warning, regardless of dose or delivery method.
Then, in November 2025, everything changed.
After an expert panel in July 2025 and a comprehensive review of scientific literature, the FDA announced it would remove black box warnings from all hormone therapy products containing estrogen.
FDA Commissioner Dr. Marty Makary called the decades-long warning “one of the greatest mistakes in modern medicine” and said the agency would “stop the fear machine steering women away from this life-changing, even lifesaving, treatment.”
What this means:
- Black box warnings are being removed from all estrogen products, including vaginal estrogen
- Labels will be rewritten with age-specific guidance
- The changes emphasize that benefits outweigh risks for women under 60 or within 10 years of menopause onset
- For vaginal estrogen specifically, the new labels will condense safety information and prioritize what’s actually relevant to low-dose vaginal formulations
Why it took so long: Thousands of petitions, advocacy from urologists and gynecologists, and grassroots efforts from women and doctors finally convinced the FDA to align its warnings with current evidence.
The new labels should appear on products within six months.
What This Means for You
If you’re experiencing vaginal dryness, painful sex, or urinary symptoms after menopause, and your doctor has recommended vaginal estrogen:
The black box warning is based on research that doesn’t apply to vaginal estrogen.
The actual evidence shows low-dose vaginal estrogen is safe and effective for most women, including many with breast cancer history.
Should you use it?
Odds are that it would be a good option for you but that’s a decision you make with your healthcare provider, based on your individual health history and circumstances.
You deserve to make that decision with accurate information—not outdated warnings based on irrelevant research.
Non-Hormonal Options Also Exist
Not everyone will choose vaginal estrogen, and that’s fine. Effective non-hormonal treatments include:
- Vaginal moisturizers (used regularly, 3-5 times per week)
- High-quality lubricants for sexual activity
- Vaginal dilators (for some conditions)
These should always be tried first. But if they’re not enough, vaginal estrogen is a safe option for most women.
The Bottom Line
After more than 20 years of misleading warnings, the FDA has finally acknowledged what the evidence has shown all along: vaginal estrogen is safe and effective.
The removal of the black box warning is a historic victory for women’s health—the result of decades of advocacy from patients, doctors, and medical societies who refused to accept that women should suffer needlessly.
But countless women already have. Women who avoided treatment because they were scared. Women who suffered through painful sex, urinary symptoms, and diminished quality of life because of warnings based on irrelevant research.
If you’re one of them, it wasn’t your fault. You were given false information that made a safe treatment seem dangerous.
Now you know the truth:
Vaginal estrogen is not the same as systemic hormone therapy. The research consistently shows it’s safe. The professional medical societies recommend it. And the FDA has finally removed the warning that scared women away from it for over two decades.
You deserve access to treatments that work—and accurate information to make informed decisions about your own body.
The labels will change within the next six months. But you don’t have to wait to have a conversation with your healthcare provider about whether vaginal estrogen is right for you.
Experiencing vaginal dryness, painful sex, or urinary symptoms?
Sexual medicine consultations can help determine whether vaginal estrogen is appropriate for you and develop a comprehensive treatment plan. Learn more about sexual medicine here.
For questions about navigating menopause, hormone therapy, or sexual changes, sex counseling provides evidence-based guidance tailored to your needs. Learn more about sex counseling here.
Dr. Lori Davis is a Doctor of Nursing Practice, board-certified Family Nurse Practitioner, and AASECT Certified Sex Counselor specializing in menopausal sexual health and genitourinary syndrome of menopause (GSM). She teaches sexuality counseling at the University of Michigan.
Note on language: In this article, terms like “woman/women” and “vagina/vulva” refer to anatomy rather than gender identity. This information applies to anyone with this anatomy, regardless of gender.
