Much to the delight of ob-gyns long espousing the upsides of hormone therapy (a.k.a. hormone replacement therapy, or HRT) for menopause symptoms, the FDA announced today that HRT products will no longer have a “black box” warning. Originally added in 2003, the label calls out risks of conditions like breast cancer, heart attack, stroke, and dementia based on a large study called the Women’s Health Initiative (WHI)—it was stopped short in 2002 when researchers first spotted such potential for poor outcomes. But in the decades since, it’s been well-established that the data didn’t support the warning that followed.
In a press conference today, FDA commissioner Marty Makary, MD, said that at the time, the FDA “reacted out of fear, not gold-standard science,” and that “instead of correcting the record, the medical establishment doubled down in groupthink.” It only makes sense that HRT prescriptions and usage plummeted in the years after the warning label was added—down from about a quarter of eligible women in 1999 to roughly 5% in 2020.
That equates to millions of women who may have suffered needlessly through menopause symptoms like hot flashes, night sweats, vaginal dryness, and insomnia that HRT could have alleviated. And the effect of leaving these symptoms untreated isn’t just poor quality of life; it can trickle into relationship and career issues, not to mention risk for downstream medical problems like recurrent urinary tract infections and a slew of conditions prompted by inadequate sleep.
Even as plenty of doctors have scrambled to address the flaws of the WHI and the benefits of HRT for quelling the symptoms of menopause, women have remained, understandably, deterred by the scary warning. “That’s the hole, literally, that we’ve been trying to dig out of,” Sharon Malone, MD, a DC-based ob-gyn and certified menopause practitioner, and chief clinical director at menopause telehealth platform Alloy, tells SELF. The decision to strip the warning makes it easier for doctors and patients to weigh the pros and cons of HRT on an individual basis, without that conversation being overshadowed by debunked findings.
Why did the black box warning for HRT exist in the first place, and what changed?
The results of the WHI initially suggested that women using the most commonly prescribed type of HRT, a combo of estrogen and progestin, had an increased likelihood of having a heart attack, stroke, breast cancer, or dementia. But when the data were reviewed, a host of problems surfaced with the study’s design and even more so, how it was interpreted.
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