The FDA Just Removed the Warning Label on Menopause Hormone Therapies

In July, the FDA convened its first-ever panel on menopause at its headquarters. Twelve leading physicians reached a unified conclusion: The “boxed warning” on hormone therapies used to treat the symptoms of menopause should be reconsidered.

Why was this warning label added in the first place? For decades, estrogen, progesterone, and testosterone (known as Hormone Replacement Therapy, or HRT) were used to treat menopause symptoms and hailed as a modern medicine miracle. Then, a large government funded trial called the Women’s Health Initiative (WHI) was launched in 1991 to understand the benefits and risks of a type of synthetic hormone in the prevention of heart disease.

On July 9, 2002, some of the WHI researchers announced preliminary findings at a press conference. Of note, this announcement went against the advice of their colleagues. Their announcement: HRT increased breast cancer risk. What we know now is that this statement was misleading, as the finding wasn’t statistically significant.

To be clear, estradiol, a hormone your body naturally makes, wasn’t even studied in the WHI. What’s more, the media storm about this statement from the WHI researchers hit before the actual publication of the paper, which meant clinicians couldn’t read the paper to make sense of the findings until days after the press release. Remember, these were the days studies arrived in print journals, not directly in your email inbox. The result? Many physicians were terrified to continue prescribing HRT and told their patients to stop taking it; others knew HRT was safe but had no platform at the time to communicate the reassuring news. The proverbial genie was out of the bottle. The takeaway: a hormone your body naturally makes is trying to kill you. Except that is not true. 

Prescriptions for hormones plummeted. Nearly all research on hormones stopped. An FDA approval for a female-dosed testosterone was declined. Training on how to prescribe hormone therapy for new physicians dried up. By 2003, the FDA had placed a box warning on all estrogen products, no matter the dose or formulation, citing elevated risks of heart attack, stroke, clots, breast cancer, and “probable dementia.” All of which are not true with vaginal estradiol or transdermal systemic preparations. 

The result was two decades of women’s unnecessary suffering. Doctors were understandably fearful of prescribing HRT, with many never trained to prescribe these hormones in the first place. Patients were left with few options, and the rates of other medications (such as antidepressants, anti-anxiety medications, blood pressure medications and lipid lowering medications) rose, likely because these medications were prescribed to treat many of the symptoms of declining hormones.

The cost to American health care and families has been significant. A 2023 survey by AARP estimates that in the U.S. alone, untreated menopause symptoms contribute to about $1.8 billion in yearly lost productivity for women, plus more than $24 billion in related health care costs. The cost of untreated menopause symptoms extends far beyond hot flashes and brain fog. It is impacting American families. A 2022 UK-based survey of more than 1,000 women by the Family Law Menopause Project and Newson Health found that 73 percent blamed menopause for divorce or serious marital strain. Behind those statistics are broken marriages, disrupted careers, rising substance use from untreated menopause symptoms, and women navigating midlife alone when support could have made all the difference.

Now, the tide is finally turning. At its July panel, the FDA heard experts acknowledge the benefits of HRT and the harms of withholding it, and it prompted the agency to reconsider the  box warning on vaginal estrogen.

Thankfully, the FDA has corrected course with yesterday’s announcement that the boxed warning on estrogen-related products will be removed. But the challenge remains: How do we retrain an entire generation of doctors who were taught that estrogen was dangerous and testosterone doesn’t exist in the female body? How do we make sure women navigating the menopause transition understand that they have treatment options? How do we get a prescription for safe vaginal estrogen into the hands of everyone who would benefit? This is where we start:

Women need to know that low-dose vaginal estrogen is safe. The box warning has historically scared many women away from using this therapy. Even if a woman is lucky enough to get a vaginal estrogen prescription (which is something far too many patients have to proactively ask for), many won’t use it after reading the warning label. Hopefully, the removal of this label will change this fact.

Vaginal estrogen should be considered essential preventive care given how it helps prevent UTIs (which become more common after menopause), which in turn could prevent antibiotic use (which disrupt our healthy microbiome, often have other side effects, and contribute to the growing problem of antibiotic resistance). As Dr. Rachel Rubin, MD, so eloquently stated at the FDA’s first hearing on this matter back in July, “If you put every woman over the age of 65 on vaginal estrogen, you’d save Medicare $13 billion per year in urinary tract prevention alone.”

We need to collectively talk about vaginal estrogen to take away any lingering taboo and make sure more of us see it as the essential preventive skin care it is. Think about it this way: Do you wait until your skin is cracked and dry before applying lotion? Probably not. So, why wait until you experience symptoms of the Genitourinary Syndrome of Menopause (GSM) to start using vaginal estrogen? Said another way: Why suffer first? And what if suffering was optional? 

The truth is that vaginal estrogen is for almost everyone who has a vagina, especially for women who’ve reached menopause. The box warning on this product was outdated, misleading, and flat-out wrong. Historic progress was made at the FDA.  

Every day, women suffer needlessly. They struggle with painful sex, recurrent UTIs, and tissue atrophy, because they’re afraid of a box warning that doesn’t apply to them. This isn’t just about correcting bad science, it’s also about restoring trust. Now, women can make informed choices without fear.

Dr. Kelly Casperson is a board-certified urologic surgeon, CEO and founder of The Casperson Clinic, and host of the top-ranking podcast You Are Not Broken. Sharon Kedar, CFA is Co-Founder, Partner of Northpond Ventures and a health advocate.