What FDA Lifting Estrogen Black Box Warnings Means for You—Doctors Say It Could Change Menopause Care Forever
One doctor calls it a 'positive step' that could impact 50 million women denied therapy
The U.S. Food and Drug Administration (FDA) announced this week that it would no longer require “black box warnings”—the highest level of medication safety warnings—on prescription low-dose estrogen products used to treat perimenopause and menopause. Years of research now show that the early concerns about hormone replacement therapy (HRT) were wrong or exaggerated and kept many women from getting the beneficial treatment they needed.
In a news conference, FDA commissioner Martin Makary, MD, MPH, said the FDA would “stop the fear machine steering women away from this life-changing, even lifesaving treatment.” Keep reading to learn everything you need to know about this landmark decision and how it stands to improve millions of women’s health and longevity in the future.
Why did the FDA remove the black box warning on estrogen?
The FDA will no longer require drug makers of low-dose estrogen, now commonly called menopausal hormone therapy (MHT), to print black box warnings (used to alert patients to serious or life-threatening risks) about potential health complications specifically related to heart disease, breast cancer and dementia on their labels. Instead, they will leave it to the pharmaceutical companies to decide how and where to include information about potential risks in their package inserts. (You know, those small-print, folded-up papers we’re supposed to read whenever we fill a prescription—but probably rarely do.)
Woman's World Answers
Internist Heather Hirsch, MD, was one of the 12 physicians who appeared before an FDA panel to advocate for the removal. She tells Woman’s World, “This is really fantastic news. Removing the [black] box warning is a signal to retrain doctors, have meaningful discussions and get more women treated.” And Dr. Hirsch knows her stuff—she’s the founder of the Menopause Clinic at Brigham and Women’s Hospital in Boston. Dr. Hirsch says, “This is a very positive step.”
In fact, many health experts now believe the broad, one-size-fits-all warnings should never have been on all estrogen drugs in the first place. “The most important thing to know is that they were actually inaccurate,” Dr. Hirsch explains. “The black box warning was just one more barrier for women to get the care they need” to help manage symptoms such as hot flashes, night sweats, vaginal dryness and more.
These black box warnings for estrogen had been in place since 2003
How exactly did we get here? In the 1990s, a long-term study called the Women’s Health Initiative (WHI) was launched. But it was prematurely shut down in 2002 over fears that hormone therapy could cause serious health conditions. Spoiler: Those findings were misunderstood and flawed.
For one example, the study tested estrogen on women who were 20 years post-menopausal, rather than the younger patients who would actually need the medication in their 40s and 50s. Dr. Hirsch says, “ A blanket black box warning was really unfair because the timing of taking these medications matters.” (In fact, studies show starting HRT earlier may even reduce Alzheimer’s risk.)
What research now shows about estrogen and health risks
Turns out, the formulation of estrogen mattered too. UCSF-trained physician and menopause expert Sophia Yen, MD, MPH, co-founder of Pandia Health, says, “Different dosages—and different delivery systems—have different effects.” She compares vaginal cream with 0.01 percent estrogen used twice a week versus an oral estrogen pill of 0.625 mg taken daily that was used in the WHI study.
She says, “They took the results of one study of a specific regimen of a specific combination of medications and then put the warning on an entire class of medications. Someone didn’t think it through. The warning was never clinically justified.”
Early fears and lasting damage
Following the faulty WHI findings, doctors and patients immediately became afraid of exploring estrogen as a treatment option to help manage symptoms of menopause. In the years following the study, the number of menopausal women taking hormone therapy nosedived from nearly 50 percent to between just 5 to 2 percent.
“The use of hormone therapy plummeted, menopause training for physicians became extinct and the harm to women has been massive,” Dr. Hirsch says. “Hormone therapy became kryptonite. No one wanted to go towards it,” adds the author of The Perimenopause Survival Guide.
As a result, now 23 years later, “many doctors have never seen a mentor counsel or prescribe menopausal hormone therapy, so they’re afraid of it.”
The box warnings hurt more women than they protected
Yes, women suffered because of the inaccurate use of this box warning. Without estrogen therapy, Dr. Hirsch says, “a massive uptick in antidepressant prescriptions were written instead.” And women turned to using hormone pellets churned out by unsafe, non-FDA-approved compounding pharmacies.
The damage of the black box warning can’t be overstated: “Twenty years of postmenopausal women have been deprived of estrogen and its potential benefits,” says Dr. Yen.
“Imagine if all of a sudden, we took thyroid medication away and left women untreated. That’s essentially what it was with menopause”
Dr. Hirsch agrees. “The bone loss that we’ve had since we stopped prescribing hormone therapy: We’ve had a massive increase in bone fractures, which lead to death, costing trillions of healthcare dollars.” She says, “I could go on and on. Women haven’t been feeling well, and we’ve been denying them treatment unnecessarily.”
She makes this comparison: “Imagine if all of a sudden, we took thyroid medication away and left women untreated. That’s essentially what it was with menopause. Denying supplemental treatment—that typifies how dangerous the black box warning was.”
In reality, estrogen can provide health benefits
Newer research offers a better picture of estrogen’s protective perks for women in perimenopause and menopause. Dr. Hirsch says, “If you start menopause hormone therapy early, it decreases heart disease risk, it decreases stroke risk, it decreases dementia risk and it doesn’t increase the risk of breast cancer.”
In fact, an analysis of 30 studies found that starting hormone replacement therapy earlier could actually save lives.
What type of estrogen are we talking about here?
The FDA is lifting its box warnings on low-dose estrogen products that can come in different forms, including creams, patches and pills. These products fall into two groups: local and systemic.
Vaginal (local) estrogen
Ultra low-dose, local estrogen medications that are applied to the vaginal area as a cream are (and have always been) overwhelmingly safe. They do not enter the bloodstream or pose a risk of blood clots. “It doesn’t travel systemically through the body.” It’s even safe for cancer survivors. Dr. Hirsch stresses, “Vaginal or local estrogen is categorically safe for all women—period.”
Dr. Yen adds, “Any post-menopausal woman can still use local vaginal estrogen. It is used to treat genitourinary symptoms and prevent urinary tract infections.”
Systemic estrogen
This can be delivered through oral pills and wearable patches. Dr. Hirsch says, “I also agree that the box warning should be off systemic estrogen medications.”
Dr. Yen says, “All systemic estrogen is generally safe within 10 years of [the onset of] menopause or under 60 years old.”
One estrogen risk to know about
It’s important to note that the FDA will continue to require a black box warning for one issue only on estrogen: risk of uterine cancer. This risk is associated with using systemic estrogen-only products without combining them with progesterone, since the body requires a balance of both. (In the medical world, that’s called “unopposed” estrogen.)
Dr. Yen urges, “All systemic estrogen needs to also be accompanied by progesterone if the person has a uterus.” This can protect against endometrial cancer.
The future looks bright for menopausal women
Dr. Hirsch says, “I’ve studied the research, and I’ve been prescribing hormone medications and seeing 100 percent of my patients do well for the last 15 years.”
She adds, “As an internal medicine doctor, I prescribe medications all the time that have risks associated with them, like antibiotics and anti-seizure medications.” But she sees estrogen as low risk. She’s hopeful that the coming years will bring improvements in both doctor training and women’s care.
Bottom line: Estrogen is safe for most, but still consult a doctor
The FDA’s decision to remove the black box warnings doesn’t mean estrogen medication is right for every patient. Dr. Hirsch says, “Nobody is saying that menopausal hormone therapy is the only way or the best way to do menopause. But all women deserve the full story to decide what’s best for them.” So consult with a doctor who is trained and knowledgeable in menopause care to determine what’s right for you.
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