Consider This from NPR - FDA reverses decades of guidance on hormone therapy for menopause

Episode Date: November 10, 2025

The FDA is removing the black box warning on estrogen therapy after two decades. Should it?Women who want to use estrogen to treat menopause symptoms often face a difficult choice.That’s because those hormone treatments contain a “black-box warning.”The Food and Drug Administration uses black box warnings to indicate a medication has potentially life threatening side effects.In the case of estrogen for menopause symptoms, an increased risk of endometrial cancer, cardiovascular disorders, dementia and breast cancer.Well those warnings are going away.  For sponsor-free episodes of Consider This, sign up for Consider This+ via Apple Podcasts or at plus.npr.org. Email us at [e-mail] episode was produced by Mia Venkat and Erika Ryan. It was edited by Courtney Dorning and Scott Hensley.Our executive producer is Sami Yenigun.Learn more about sponsor message choices: podcastchoices.com/adchoicesNPR Privacy Policy

About 20 years ago, the Food and Drug Administration added a black box warning to hormones used to treat menopause symptoms, symptoms that include night sweats, brain fog, weight gain, and urinary tract infections. Prescriptions for hormone replacement therapy plummeted in the United States. Women flushed their pills down the toilet. 50 million plus women have not been offered the incredible potential health benefits of hormone replacement. therapy because of medical dogma. That's Dr. Marty McCarrie, the FDA Commissioner. He was speaking at a July panel about menopause and hormone replacement therapy for women. The addition of that black box warning, the strongest to label the FDA uses to warn of drug-related risks, came after a 2002 study by the Women's Health Initiative, which found use of hormone replacement therapy led to higher risks of cardiovascular disease, breast cancer, uterine cancer, stroke, and dementia. But

Over the last two decades, as more and more studies have been done, many doctors say they know a lot more about how these medications can help women. When we looked at all the data, not just the WHOI, we realized that for women who were under 60 or within 10 years of menopause, it was not only effective. It was safe and actually had benefits on preventing heart disease, potentially preventing fractures, treating hot flushes and night sweats. That's Joanne Pinkerton, a menopause specialist. And she says she's seen how menopause affects women firsthand in her practice and how hormone

replacement therapy has helped. We prescribe these more contemporary hormones all the time. And one of the most gratifying parts of my job is to take somebody who's absolutely miserable who says, I can't think, I can't function, it's affecting my work, it's affecting my relationships at home. I'm irritable. I'm snappy. I wake up four or five times at night, covers on, covers off, having to change.

clothes, and within, you know, for eight weeks, they are dramatically improved. Pankerton says she has patients who pick up the medication, read the black box label warning, and they get scared and decide not to use it. That's what happens every day in my clinical practice. And then, you know, every year, maybe two or three women end up with sepsis from a urinary tract infection that I feel could have been prevented. Dr. Pankerton had a patient who'd been a horseback rider, and she started having urinary tract infections that were so bad, she had to stop writing. And I'm like, okay, so this is straightforward vaginal atrophy, genitory syndrome of menopause, you know, the whole constellation. We started her on vaginal estrogen. She had such severe symptoms, took about

six months, and then she walks in smiling, and she goes, I'm horseback riding again. And she hasn't had any urinary tract infections since she became regular and faithful with her vaginal estrogen. Consider this. The FDA is removing the black box warning on hormone therapy for menopause. What are the reasons why? And is it safe for everyone? I think we'll find that not only will the providers feel more comfort with prescribing, more women will have access, and I think their relationships will improve and their health will improve. Coming up, we speak to FDA Commissioner Marty McCarrie about this decision. From NPR, I'm Juana Summers.

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Commissioner Marty McCarray led the way on that decision, and he's here with me in studio. Now, thanks for coming by. Great to be with you, Juana. So, I mean, this black box warning that we're talking about it, it's been in place on all estrogen treatments for more than two decades since back in 2003. The timing. Why remove it now? Well, the fear machine did start in 2003, after a 2002 study that really hit the airwaves in the media with a big splash, scaring women out of hormone replacement therapy in the postmenopausal setting. Up to one in four Americans were taking it. Women lived longer and felt better, but then it got deemed a carcinogen based on this study.

It turns out when the study results were finally released after the media announcement, there was no statistically significant increased risk of breast cancer. there was a lower rate of breast cancer in the estrogen-only group, and so it ends up being very nuanced, and the cardiovascular benefits are profound when hormone replacement therapy started within 10 years of the onset of menopause. So there is some nuance here, but unfortunately the fear machine has dominated the field, and women have been talked out of it. They've been denied or never offered hormone replacement therapy despite the profound short-term and long-term benefits. Let's talk about that for a second, because there is a lot of nuance here. Just spell out

plainly for us some of the benefits of hormone therapy as you see them. Yeah, so starting hormone replacement therapy around the time of menopause, not only can alleviate the short-term symptoms of menopause. That is, the hot flashes, night sweats, mood swings, weight gain, difficulty, difficulty, difficulty, there are 50-plus different symptoms, and every woman experiences them differently. You know, we were taught at medical school that some women have symptoms, but they're usually mild and they last just a couple years. Not true. 80-plus percent of women have symptoms. The average duration is eight years, and for many women, it is severe. They are debilitating. The long-term benefits are remarkable and massively misunderstood. It reduces

the risk of bone fractures later in life by 50 to 60 percent. That's a New England Journal study. It reduces cognitive decline by up to 64 percent. In one study, reduced the risk of Alzheimer's by 35 percent. And there are cardiovascular benefits when it started within 10 years of the onset of menopause. Does it matter if a woman is taking a pill, which is systemic or using a cream, which is a local treatment? So there are pills, there are patches, there are creams and gels. And so all of these products had a black box warning from the FDA as a part of this pile on, as a part of this bandwagon thinking in 2002, 2003. We are removing those and putting the nuances of the risks in the package insert and the idea is to get better information in front of

women. Spell out some of these risks for us because there are still risks associated with hormone replacement therapy. Is that right? Yeah. When started more than 10 years after the onset of menopause, then you actually see some of these risks that are, have been attributed to all hormone replacement therapy products. And that's probably because the body naturally is making estrogen. And that increases nitric oxide. It keeps the blood vessels soft and the walls soft and healthy and dilated. And so when it started such that there's not a gap where your body is without it, then there are cardiovascular benefits where the reduction in heart disease has been noted to be 35, 30 to 50 percent. That is a 30 to 50 percent reduction in heart disease.

And in a study in circulation two years ago, a 48% decline in heart attack deaths. And so that is because of the effect of estrogen. So if it started too late, the blood vessels are narrowing, and the theory is that they're hardening and that aging and atherosclerosis can then result in a situation that is prone for a blood clot with hormone therapy. Commissioner, are there women who should not be using hormone therapy? Yes, many doctors do identify some contraindications. A woman with an underlying risk for blood clots, a woman with active breast cancer or past breast cancer, depending on the practice style of the physician. But the vast majority of women who go through menopause, which is about 2 million women a year, are great candidates for hormone replacement therapy. If a woman has a uterus, it's important for them to also take progesterone to reduce the risk of endometrial hyperplacement. and possibly uterine cancer. But women who have been taking this for a long time have reported

tremendous benefits, and they're talking about it on social media now. So there is a bit of an awakening. I do want to ask you about the process here, because in preparing to remove the black box warning, there's usually a formal, very detailed process. Things seem to play out differently this time. Tell us why. Yeah, we're getting things done. In this administration at the FDA, we're getting things done. They were talking about removing or banning a food die for 35 years before I got to the FDA. Within weeks, we took action to remove nine petroleum based food dies from the food supply. That's all artificial dies. In this case, we are responding to a petition that was filed in 2016. It was basically blown off. It was refiled in 2025. We held an

expert panel. We didn't go through the long bureaucratic, expensive process of bringing in conflicted experts to talk about a product. We brought in a range of diverse medical experts who passionately made the case for stopping the sphere machine by removing the black box warnings around cardiovascular disease, dementia, and breast cancer. I mean, over the last several years in our society, I don't have to tell you this, but there has been this increasing recognition of the health challenges, the very real challenges that women face during menopause. And you and I were talking about the nuance in this conversation earlier. Do you worry at all that by removing this black box warning that it might result in the pendulum tipping the other way and there's now

going to be an overuse of hormone therapy? Well, tragically over the last 23 years, 50 million women have been denied or talked out of hormone replacement therapy in part because of the fear machine that hormone replacement therapy is a carcinogen. It causes breast cancer. We can argue whether or not the old type of progesterone use called MPA in that original study may have slightly increased the risk of breast cancer in women who took that MPA, but no clinical trial has ever found that it increases the risk of breast cancer mortality. And if it did, that harm would be far eclipsed by the profound cardiovascular benefits. You know, early on in the 1920s, Mayo Clinic researchers noted that young girls who had their ovaries removed went on to have heart disease in their 30s and 40s

suggesting a profound cardiovascular protective effect. And so that's the nuanced conversation that people need to have. We've been speaking with FDA Commissioner, Dr. Marty McCarrie, coming in to talk to us about the FDA's decision to remove black box warnings for estrogen treatments for menopause. Thank you so much for coming by our studios. Great to be with you, Juana. This episode was produced by Mia Venkat and Erica Ryan. It was edited by Courtney Dorney and Scott Hensley. Our executive producer is Sammy Yenigan. And before we wrap up, a quick plug for our recent bonus episode,

where you can hear an interview with a fifth-generation cattle rancher from South Dakota, who voted for President Trump and says his administration's approach to beef prices is hurting farmers. Bonus episodes of Consider This are one perk for our NPR Plus support. reporters who also hear every episode without sponsor messages. Learn more at plus.npr.org. It's Consider This from NPR. I'm Juana Summers.