FDA reverses decades of guidance on hormone therapy for menopause

Summary

---

Consider This from NPR

Episode: FDA Reverses Decades of Guidance on Hormone Therapy for Menopause

Air Date: November 10, 2025
Host: Juana Summers
Guests: Dr. Marty Makary (FDA Commissioner), Dr. Joanne Pinkerton (Menopause Specialist)

---

Episode Overview

This episode examines the FDA’s landmark decision to remove the black box warning — the strongest caution for prescription drugs — from hormone replacement therapy (HRT) for menopause. Host Juana Summers, along with expert guests Dr. Marty Makary and Dr. Joanne Pinkerton, discuss why the change was made, the evolving science around HRT, and what this means for the millions of women experiencing menopause symptoms. The conversation covers historical context, clinical evidence, risks and benefits, and implications for patients and providers.

---

Key Discussion Points & Insights

1. The History and Impact of the Black Box Warning

• [00:00 – 01:08]
  • In 2002, a major Women’s Health Initiative (WHI) study found risks — cardiovascular disease, breast and uterine cancer, stroke, and dementia — linked to HRT, prompting the FDA to add a black box warning in 2003.
  • As a result, HRT prescriptions plummeted (Dr. Makary: “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 of health benefits of hormone replacement therapy because of medical dogma.” [00:13])
  • Dr. Joanne Pinkerton, a menopause specialist, notes many women still suffer debilitating symptoms due to fear and stigma attached to hormone therapy.

2. Evolving Medical Understanding

• [01:08 – 02:55]
  • More recent analyses show HRT can be safe — and beneficial — for women under 60 or within 10 years of menopause.
    • Dr. Pinkerton: “When we looked at all the data, not just the WHI, 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 sweatshirts.” [01:08]
  • HRT dramatically improves quality of life for many, reducing symptoms like night sweats, brain fog, and recurrent urinary tract infections.
    • Dr. Pinkerton shares a compelling case: “One of the most gratifying parts of my job is to take somebody who is absolutely miserable... And within, you know, four to eight weeks, they are dramatically improved.” [01:37]
    • She describes a patient who returned to horseback riding after resolving UTIs with vaginal estrogen: “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.” [02:32]

3. The FDA’s Decision and Rationale

• [03:03 – 04:50]
  • The FDA, led by Dr. Makary, is removing the black box warning based on nuanced, updated data.
    • “Well, the fear machine did start in 2003... But then it got deemed a carcinogen. Based on this study. Turns out... 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.” [04:58]
  • Makary underscores profound cardiovascular and cognitive benefits when HRT is started soon after menopause: “The cardiovascular benefits are profound when hormone replacement therapy started within 10 years of the onset of menopause.” [05:40]
  • The FDA’s new approach aims for clarity and better patient information. Nuances and individual risk are now included in package inserts, not a blanket warning.

4. Risks, Contraindications, and Individualization

• [07:32 – 08:48]
  • Risks of HRT remain, especially if started late (>10 years post-menopause), due to hardened blood vessels and increased clot risk.
    • “When started more than 10 years after the onset of menopause, then you actually see some of these risks...” [07:37]
  • Major contraindications: history of blood clots, active or past breast cancer; women with a uterus should also take progesterone to mitigate cancer risk.
  • For the majority: “The vast majority of women who go through menopause, which is about 2 million women a year, are great candidates for hormone replacement therapy.” [08:51]

5. FDA’s Fast-Tracked Process

• [09:34 – 10:34]
  • The agency shortcut its usual, lengthy review, convening diverse outside experts directly and responding to petitions ignored for nearly a decade.
    • “We didn't go through the long, bureaucratic, expensive process of bringing in conflicted experts... We brought in a range of diverse medical experts who passionately made the case for stopping this fear machine by removing the black box warnings...” [09:43]

6. Balancing Benefit and Risk — Avoiding Overcorrection

• [10:34 – 11:57]
  • Still, Dr. Makary cautions: “We can argue whether or not the old type of progesterone used... may have slightly increased the risk of breast cancer... But no clinical trial has ever found that it increases the risk of breast cancer mortality.” [10:55]
  • He stresses the conversation should be individualized and evidence-based — not dominated by past fears or new hype.

---

Notable Quotes & Memorable Moments

• On the power of the black box warning:
  • Dr. Joanne Pinkerton: “I have patients who pick up the medication, read the black box label warning, and they get scared and decide not to use it.” [02:04]
• On data and empowerment:
  • Dr. Marty Makary: “Women lived longer and felt better. But then it got deemed a carcinogen... There was a lower rate of breast cancer in the estrogen only group.” [04:58]
• On risk and medical nuance:
  • Dr. Makary: “The long term benefits are remarkable and massively misunderstood. It reduces the risk of bone fractures later in life by 50 to 60%... It reduces cognitive decline by up to 64% in one study, reduced the risk of ulcer by 35%...” [06:38]
• On accelerating FDA decisions:
  • Dr. Makary: “We are getting things done in this administration at the FDA, we're getting things done. They were talking about removing or banning a food dye for 35 years... Within weeks, we took action...” [09:43]
• On shifting the narrative:
  • Dr. Makary: “50 million women have been denied or talked out of hormone replacement therapy, in part because of the fear machine...” [10:55]

---

Timestamps for Key Segments

• History of the warning & collapse in HRT prescribing: 00:00 – 01:08
• Clinical experience and benefits of hormone therapy: 01:27 – 02:55
• FDA’s rationale for removing the black box: 04:58 – 07:06
• Details on risks and individualized recommendations: 07:32 – 09:34
• FDA’s process for the reversal decision: 09:34 – 10:34
• Cautions about overcorrection and summary: 10:34 – 11:57

---

Tone & Language

The conversation is assertive, clear, and nuanced — balancing decades of medical caution with contemporary evidence. Both experts emphasize moving away from fear-based medicine and toward individualized care, while maintaining a respect for complexity and risk.

---

Summary prepared for listeners seeking an in-depth understanding of this pivotal FDA decision and its implications for menopause treatment.

Transcript

[Juana Summers]

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.

[Dr. Marty Makary]

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 of health benefits of hormone replacement therapy because of medical dogma.

[Juana Summers]

That's Dr. Marty Makary, 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 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.

[Joanne Pinkerton]

When we looked at all the data, not just the WHI, 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 sweatshirts.

[Juana Summers]

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.

[Joanne Pinkerton]

We prescribe these more contemporary hormones all the time. And one of the most gratifying parts of my job is to take somebody who is 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 my clothes. And within, you know, four to eight weeks, they are dramatically improved.

[Juana Summers]

Pinkerton 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.

[Joanne Pinkerton]

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.

[Juana Summers]

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 riding.

[Joanne Pinkerton]

And I'm like, okay, so this is straightforward vaginal atrophy, genitourinary syndrome, and menopause. You know, the whole constellation. We started her on vaginal estrogen. She was 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.

[Juana Summers]

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?

[Joanne Pinkerton]

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.

[Juana Summers]

Coming up, we speak to FDA Commissioner Marty Makary about this decision. From npr, I'm Juana Summers.

[Dr. Marty Makary]

This message comes from Grammarly. They have features that are tailor made for working professionals so you can get all your writing done from start to finish all in one place. Grammarly is designed to help professionals with real time writing support on any project, email and more. Sign up for free and experience how Grammarly can elevate your professional writing from start to finish. Visit Grammarly.com podcast. That's Grammarly.com podcast.

[Juana Summers]

There are tens of thousands of veterans behind bars in the US Often without any of the mental health services they may need.

[Dr. Marty Makary]

When you go to prison, you automatically lose your benefits. As a veteran, you become a war to the state.

[Juana Summers]

How much do we owe these veterans who have fought our wars? Listen now to the Sunday story on the UPVERSE podcast from npr. It's Consider this from npr. For more than two decades, the Food and Drug Administration has warned women about the potential risks of using estrogen to treat menopause symptoms. And that's because early studies showed an increased risk of endometrial cancer, cardiovascular disorders and breast cancer. Well, those warnings are going away and FDA Commissioner Marty Makary led the way on that decision and he's here with me in studio now. Thanks for coming by.

[Dr. Marty Makary]

Great to be with you, Juana.

[Juana Summers]

So I mean, the split black box warning that we're talking about, it's been in place on all estrogen treatments for more than two decades, since back in 2003. The timing, why remove it now?

[Dr. Marty Makary]

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 Turns out when the study results were finally released and 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.

[Juana Summers]

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.

[Dr. Marty Makary]

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 sleeping, pain with sexual activity. There are 50 plus different symptoms and every woman experiences them differently. You know, we were taught at 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 8 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%. That's a new England Journal study. It reduces cognitive decline by up to 64% in one study, reduced the risk of ulcer by 35%. And there are cardiovascular benefits when it started, within 10 years, the onset of menopause.

[Juana Summers]

Does it matter if a woman is taking a pill which is systemic, or using a cream which is a local treatment?

[Dr. Marty Makary]

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, 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.

[Juana Summers]

Some of these risks for us. Because there are still risks associated with hormone replacement therapy, is that right?

[Dr. Marty Makary]

Yeah. When started more than 10 years after the onset of menopause, then you actually see some of these risks that 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%. That is a 30 to 50% 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.

[Juana Summers]

Commissioner, are there women who should not be using hormone therapy?

[Dr. Marty Makary]

Yes. Many doctors do identify some contraindications. A woman with an underlying risk for blood clots, a woman 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 hyperplasia 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.

[Juana Summers]

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.

[Dr. Marty Makary]

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 dye for 35 years before I got to the FDA. Within weeks, we took action to remove nine petroleum based food dyes from the food supply. That's all artificial dyes. 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 this fear machine by removing the black box warnings around cardiovascular disease, dementia and breast cancer.

[Juana Summers]

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?

[Dr. Marty Makary]

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 used, called MPA, in that original study may have slightly increased the risk of breast cancer in women who took that drug, 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 thickness 30s and 40s, suggesting a profound cardiovascular protective effect. And so that's the nuanced conversation that people need to have.

[Juana Summers]

We've been speaking with FDA Commissioner Dr. Marty Makary, 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 studio today.

[Dr. Marty Makary]

Great to be with you, Juana.

[Juana Summers]

This episode was produced by Mia Venkat and Erica Ryan. It was edited by Courtney Dorning and Scott Hensley. Our executive producer is Sammy Yenigun. 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 supporters who also hear every episode without sponsor messages. Learn more at plus.NPR.org It's Consider this from NPR. I'm Juana Summers.

[Joanne Pinkerton]

I'm Rachel Martin. If you're tired of small talk, check out the Wild Card Podcast. I invite influential thinkers to open up about the big topics we all think about, but rarely talk about. Tune in this fall to hear Mel Robbins, Malala Yousafzai and Brene Brown talk about everything from grief and God to ambition and forgiveness. Watch or listen on the NPR app, YouTube or wherever you get your podcasts.

[Dr. Marty Makary]

Making time for the news is important, but when you need a break, we've got you covered on All Songs Considered, NPR's music podcast. Think of it like a music discovery show. A well deserved escape with friends. And yeah, some serious music insight. I'm Keep it real. I have no idea what this story is about. Hear new episodes of All Songs Considered every Tuesday day wherever you get Podcasts.

[Juana Summers]

Want to hear this podcast without sponsor breaks? Amazon prime members can listen to Consider this sponsor free through Amazon Music. Or you can also support NPR's vital journalism and get consider this plus@ +npr.org that's +npr.org.