A recent drug labeling change from the FDA concerning hormone replacement therapy (HRT) could make a real difference for millions of perimenopausal and menopausal women across the United States.
25 years ago, hormone replacement therapy for menopause symptoms was common
In the 90s and early 2000s, millions of American women took hormone replacement therapy (HRT) medications for relief from symptoms caused by the natural drop off of estrogen and progesterone that occurs as the ovaries ramp down hormone production over a period of four to eight years—a process known as perimenopause. A woman is considered to be in menopause when her menstrual cycle completely stops, and she has not had a period for twelve months.
Starting in perimenopause and accelerating in menopause, the naturally occurring decrease in estrogen and progesterone is associated with dozens of symptoms affecting virtually every body system, from night sweats and brain fog, to eczema, vaginal dryness, and low libido, to weight gain and new food sensitivities. In other words, menopause isn’t just associated with “pesky” symptoms—for some women, symptoms can be downright debilitating.
According to menopause expert and OB/GYN Dr. Mary Claire Haver in her book The New Menopause: Navigating Your Path through Hormonal Change with Passion, Power, and Purpose, menopause also comes with certain health risks related to low estrogen. These include osteoporosis, coronary artery disease, insulin resistance and diabetes, inflammation in the brain, and muscle mass loss (Haver, 71-72).
Is hormone replacement therapy the same as hormonal birth control?
In contrast to hormonal birth control, which seeks to override the body’s natural hormonal production and rhythms with the goal of stopping ovulation, hormone replacement therapy adds back estrogen and progesterone (either synthetic or bioidentical) to support the body through the transition to menopause. Though some hormone combinations prescribed for menopause are also prescribed for birth control, the dosages are significantly less for HRT and their function is supplementation, not hormonal suppression. (Though Dr. Haver does sometimes prescribe hormonal birth control for perimenopausal symptoms, Natural Womanhood takes issue with this approach.)
In contrast to hormonal birth control, which seeks to override the body’s natural hormonal production and rhythms with the goal of stopping ovulation, hormone replacement therapy adds back estrogen and progesterone (either synthetic or bioidentical) to support the body through the transition to menopause. Though some hormone combinations prescribed for menopause are also prescribed for birth control, the dosages are significantly less for HRT and their function is supplementation, not hormonal suppression.
2002: The year hormone replacement therapy became unpopular
But following the release of preliminary data from the 2002 Women’s Health Initiative (WHI) study—which suggested a slight increase in breast cancer diagnoses for users of hormone replacement therapy (HRT, also known as menopause replacement therapy or MHT)-—HRT prescriptions dropped by 80% “practically overnight” (Haver, 25).
And in 2003, the FDA initiated labeling changes, eventually escalating to ‘black box’ warnings (the agency’s highest level of drug safety warning) on HRT products. These warnings cautioned users that estrogen-containing HRT medications, whether estrogen alone or in combination with progestin or progesterone, were associated with increased risk of heart attacks, cancer, strokes, and dementia.
Two decades of research paint a different picture of HRT safety
In the intervening decades, however, several themes have emerged, summarized in the 2018 book Estrogen Matters by oncologist Dr. Avrum Bluming and social psychologist Dr. Carol Tavris (an explainer interview with the authors on the Hello Menopause podcast is here). Firstly, the increase in breast cancer risk was so small as to be statistically nonsignificant: a mere 1 additional case per 1,000 women using HRT. Additionally, the increased risk was not noted in women who used HRT for five years or less.
Second, while 20+ formulations of HRT for moderate to severe menopausal symptoms exist today, only one was studied in the 2002 WHI trial, and that formulation (which included an oral form of the same progestin as the controversial and risky Depo-Provera shot) is no longer commonly used for HRT. Experts now believe that the slight increase in breast cancer risk was actually related to that particular progestin in the studied HRT formulation, not due to the estrogen it contained.
But doesn’t estrogen cause blood clots?
We know that estrogen-containing birth control is associated with increased risk of strokes, blood clots, heart attacks, and breast cancer, but recall that hormone replacement therapy medications are given in much smaller doses and to supplement hormones to correct deficiency in the body. Advocates have also long pointed out that topical vaginal estrogen, which is often prescribed for perimenopausal vaginal dryness or other genitourinary symptoms, does not have the same clotting risks as oral estrogen (Haver 97-99).
We know that estrogen-containing birth control is associated with increased risk of strokes, blood clots, heart attacks, and breast cancer, but recall that hormone replacement therapy medications are given in much smaller doses and to supplement hormones to correct deficiency in the body.
Why bioidentical hormones matter for hormone replacement therapy
Dr. Haver categorizes HRT medications as synthetic or bioidentical. While both kinds are created in a lab, synthetic hormones “are made from chemical compounds” that “do not have the same molecular structure as the original sex hormones in your body, so your body converts them into usable form” (Haver, 93). In contrast, bioidentical hormones “are made from naturally derived ingredients and are usually plant derived. They are structurally identical to those naturally produced by the body” (Haver, 94). Haver encourages bioidentical hormone use when possible because “it makes sense to me to ‘give them back the water they were drinking’” (Haver, 94).
Haver also differentiates between compounded bioidentical vs.FDA-approved bioidentical hormones and lays out when she recommends one vs. the other.
HRT needs to be started by age 60 or within 10 years of menopause
Third, researchers have learned that the timing of HRT matters a great deal. The average age of participants in the 2002 WHI study was 63. But there appears to be a “window of opportunity” during which HRT can be most beneficial by getting out in front of age-related cardiovascular disease risk. HRT started after this time period may no longer be worth it in a risk-benefit analysis.
Specifically, when started within ten years of menopause (the average age of menopause for American women is 51) or by age 60, use of HRT is associated with a lower risk of cardiovascular disease, deaths from all causes, and strokes, according to a November 2025 commentary from the FDA published in JAMA, outlining the reason behind the labeling changes.
The FDA noted, “Hormone therapy has also been associated with a 25% to 50% reduction in fatal cardiovascular events2 (the leading cause of death in women), a 50% to 60% reduction in bone fractures,3 a 64% reduction in cognitive decline,4 and a 35% decreased risk of Alzheimer disease.5” This makes sense given estrogen’s protective effect for bone, breast, and brain health as Natural Womanhood has showcased in its Reasons Women Need Periods series.
Estrogen-containing HRT medications will no longer carry the black box warning
On November 10, 2025, HHS announced that “following a comprehensive review of the scientific literature, an expert panel in July, and a public comment period,” “black box” warnings concerning risk of cardiovascular disease, dementia, and breast cancer will be removed from estrogen-containing HRT medications. That includes both estrogen-only products as well as estrogen-progestin medications.
One warning that will remain in place will be risk of endometrial cancer from use of estrogen-only medications, which would be used by women who have had hysterectomies (a woman with a uterus will need progesterone along with estrogen).
HRT isn’t the only treatment option for perimenopausal and menopausal symptoms
Some Natural Womanhood readers may be reluctant to turn to HRT as a first-line treatment for perimenopause or menopause symptoms, wondering if other natural or holistic treatment options exist. For example, magnesium supplementation may help with insomnia and/or anxiety, DHEA may be given for pain with intercourse related to vaginal dryness and/or atrophy, diindolymethane (DIM) may be taken for hormone balance, and evening primrose oil may ease hot flashes and night sweats.
Still, in a 2024 episode of the Hormone Genius podcast, NaProTECHNOLOGY-trained women’s health nurse practitioner Teresa Kenney affirmed the value of hormone replacement therapy, noting that while she does sometimes recommend supplements to her perimenopausal and menopausal patients, they “will never, ever take the place of HRT. They won’t even come close.”
Certainly, prioritizing HRT access does not negate the value of lifestyle interventions to manage or minimize perimenopausal or menopausal symptoms. Among proven effective interventions is exercise, particularly strength training with weights (Dr. Stacy Sims, an expert on the intersection of women’s hormones and fitness even encourages lifting heavy weights, jump training, and sprint training when a woman hits her 50s!), and, as Kenney noted, incorporating movement throughout the day rather than just 30-45 minute chunks a couple times per week. Cycle charting can also help identify when a woman enters perimenopause and may inform appropriate timing of medications. A roundup of key lifestyle interventions for perimenopause and menopause is here.
Find a healthcare practitioner skilled in providing menopause care
Both Teresa Kenney and Dr. Mary Claire Haver emphasized the importance of seeking out a healthcare practitioner specifically skilled in menopause treatment and care. While millions of women enter perimenopause each year, menopause education has historically been a mere footnote in medical school curricula.
As one example of the real-life implications of this educational gap, while the FDA labeling change is a welcome one based on research, during the press conference announcing it, FDA Commissioner Dr. Marty Makary encouraged “having a doctor evaluate your estrogen levels to figure out when is the right time to start.”
In contrast, as the progressive magazine Mother Jones noted, “the North American Menopause Society explicitly recommends against testing for estrogen levels in perimenopausal women because they fluctuate so much throughout a woman’s cycle. Instead, doctors should prescribe estrogen based on a woman’s symptoms.” Makary’s misstep was a reminder that while the evidence-based change in HRT medication labels is a welcome one, we have a long way to go when it comes to perimenopause and menopause education and treatment.
The bottom line
The FDA’s removal of black box warnings from HRT medications is a promising step towards real relief for women experiencing perimenopause or menopause. As Commissioner Makary’s slip-up exemplifies, however, much work remains to be done in educating both the public and healthcare professionals about appropriate care for women at the end of their childbearing years. For more information on perimenopause and menopause, please see Dr. Mary Claire Haver’s The New Menopause, the Hormone Genius podcast episode on the topic, or the Let’s Talk Menopause website.
