Podcast Summary: Dr. Chapa’s OBGYN Clinical Pearls

Episode: HISTORY MADE: New HRT News TODAY (11/10/25)
Date: November 10, 2025
Host: Dr. Chapa
Topic: Historic FDA Decision to Remove Black Box Warning on Hormone Replacement Therapy (HRT)

Episode Overview

This high-energy, fast-paced episode breaks down a landmark announcement: the FDA’s decision to remove the black box warning for most hormone replacement therapy (HRT) products used in menopause. Dr. Chapa explores the historical context, recent evidence, and the clinical and practical ramifications of this decision, highlighting the shift from decades of caution and fear towards renewed recognition of HRT’s health benefits for women.

Key Discussion Points & Insights

1. Historical Context and the "American Tragedy"

The episode opens with commentary on what’s considered a major misstep in women’s health: a 20+ year-old government study suggesting HRT increases breast cancer risk.
Dr. Chapa notes that this led to mass avoidance of HRT by both patients and providers out of fear, despite growing evidence of benefits and flaws in the original study.

"It's an American tragedy. I do think it's one of the biggest mistakes in modern medicine." — Dr. Chapa [00:08]

2. Announcement: Removal of Black Box Warning (11/10/25)

The FDA has decided to remove the black box warning from menopausal and perimenopausal HRT, including patches and transdermal options, following the latest scientific evidence and expert panel recommendations.
Dr. Chapa emphasizes the historical significance of this change and the speed of this breaking news.

"This is historic...something that has blocked countless hundreds of women from starting hormone replacement therapy out of fear is now going away." — Dr. Chapa [00:45]

3. The Evidence Driving Change

New analyses confirm the original breast cancer risk data were statistically non-significant—meaning, there is no clear evidence that HRT increases breast cancer mortality.
Randomized studies now show that, when started within 10 years of menopause (generally before age 60), HRT brings significant health benefits.

"There was no statistical significance and no subsequent clinical trial has ever shown increase in breast cancer mortality." — Dr. Chapa [00:27]

"Updated evidence shows a statistically non significant increase in the risk of breast cancer diagnosis." — Dr. Chapa quoting FDA panel [08:11]

4. Health Benefits of HRT in Focus

Dr. Chapa details the confirmed benefits, supported by new and existing studies:
- Reduction in cognitive decline and Alzheimer’s risk
- Decreased rates of heart attack and cardiovascular disease
- Marked decrease in bone fractures
- Overall reduction in all-cause mortality
"Women may also reduce the risk of cardiovascular disease by as much as 50%, Alzheimer's disease by 35%, and bone fractures by 50 to 60%." — Dr. Chapa reading HHS statement [13:52]

5. Changes & What Stays the Same

What’s Changing:
- Removal of references to cardiovascular disease, breast cancer, and dementia as contraindications in the black box warning for most HRT products
- Major rewording of patient information and package inserts likely to follow
What’s Not Changing:
- The black box warning still applies to systemic estrogen-only therapy regarding the risk of endometrial (uterine) cancer unless balanced with progestogen.
"The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen alone products ... that's real." — Dr. Chapa [10:55]

6. Community & Advocacy

Dr. Chapa highlights the collaborative spirit of the medical community, giving personal shout-outs to colleagues and listeners for rapidly sharing key developments and holding one another to high standards of evidence-based care.

"Encouragement breeds encouragement. I think we hold each other to a higher level of evidence based data and care." — Dr. Chapa [06:07]

7. Practical Advice for Clinicians

For HRT to confer maximal benefit, therapy should be initiated within 10 years of menopause onset and usually before age 60.
The episode encourages clinicians to review updated guidelines, revisit their approach to discussing HRT, and consult prior podcast episodes for deep dives into the data.

Notable Quotes & Memorable Moments

On the reversal's magnitude:

"...for the first time, now every time before this, hormone therapy always had the caveat of if the patient accepts risks. Now...notice it says long term health benefits. Amazing." — Dr. Chapa [05:12]
On the bad data of the original warning:

"Because the breast cancer data was messed up. Messed up. According to the WHI, it was bad data." — Dr. Chapa [08:45]
Numbers that matter:

"Randomized studies show that women who initiate HRT...within 10 years of the onset of menopause...have a reduction in all cause mortality and fractures...Cardiovascular disease by as much as 50%, Alzheimer's by 35% and bone fractures by 50 to 60%." — Dr. Chapa reading HHS [13:52]

Timestamps for Important Segments

00:08 – 01:00: Discussion of the original "HRT and breast cancer" controversy
01:01 – 03:40: Announcement & personal reflections on breaking news
04:50 – 06:21: Community and colleague shout-outs; podcast’s advocacy roots
08:10 – 10:00: Dissection of risk data and FDA panel position
10:50 – 12:20: What the black box removal does and does not affect (estrogen-only vs. combination products)
13:52 – 15:24: Reading new benefit statistics from HHS
16:00 – 16:20: Final takeaways & future directions

Tone & Style

Dr. Chapa’s tone is fast, conversational, and candid, with exuberant support for the decision:

"I love it, I love it, I love it." [06:20]
"Phenomenal. Phenomenal. Phenomenal. So this is good news. Again. Just wanted to put this out there." [15:14]

Key Takeaways

The FDA has agreed to remove the black box warning for most HRT, reflecting a consensus that the original breast cancer risk was overstated.
Evidence now overwhelmingly shows HRT—if started at the right time—provides major health benefits for women in menopause, with minimal increased cancer risk.
Endometrial cancer risk with estrogen-only therapy still warrants the black box—this has not changed.
The field is shifting toward a more open, evidence-based approach to HRT, and clinicians are encouraged to confidently discuss these changes with patients.

Transcript

A (0:08)

It's an American tragedy. I do think it's one of the biggest mistakes in modern medicine.

B (0:14)

That mistake, according to FDA Commissioner Dr. Marty Makary, is the conclusion from a government study more than 20 years ago that suggested hormone therapy leads to an increased risk of breast cancer.

A (0:27)

There was no statistical significance and no subsequent clinical trial has ever shown increase in breast cancer mortality. And look at the long term health benefits, the reduction in cognitive decline in heart attacks, in bone fractures, in other conditions including cancer and diabetes that have been suggested in some studies.

B (0:45)

First on CBS News podcast Family. That was on CBS MORNINGS today. Now, just as point of reference, this is November 10, 2025. And I had to get this out. I'm in the middle of doing other things, clinical duties. But this was a big deal. I mean, this is historic. This is we're seeing history right now unfold, at least in terms of medications because something that has blocked countless hundreds of women from starting menopausal or perimenopausal hormone replacement therapy out of fear is now going away. Okay, now to be very clear, I mean, it hasn't actually happened yet, but the promise is made, the decision is made, has been made to get rid of the black box warning on hormone replacement therapy. Now that includes patches and transdermal options as well. This is a big, big deal. That was CBS Mornings, not a sponsor with their interview with FDA Commissioner Dr. Marty Makary. Y', all, this happened literally about oh, two, three hours ago. So I'm just going to give you a little blurb here because we have covered this. Go back to the archive. We said this was going happen. Now we're not fortune tellers. We don't play games. But we knew what was coming down the pike. We did this just several weeks ago knowing what was on the horizon. This actually comes after an FDA panel of experts and witnesses who said, yeah, yeah, I mean that data was, was jacked. I mean, historically, look at the numbers, around 1999 ish or so or by the start of 2000, about one in four women were on menopausal hormone replacement therapy, mainly for relief of vasomotor symptoms. Well, spring forward to 20 years. So now just five years ago to 2020, and that number was less than about one in 25. And the main reason was it wasn't lack of availability. We actually have a bunch more products. But ironically, it was because of fear, because of the black box warning on perimenopausal and menopausal hormone therapy. And that scared a lot of people. The Black box war member is the US government's highest warning of of a medication. So this is a big deal. The HHS just announced this this morning again on November 10, 2025. So this is going to be very fast. I just want to let you know what, what's going on, what happened, what was removed and what is not removed. Now to be very clear, something was not removed from this. Okay? So we gotta make sure we understand what it is and what it is not doing. But I thought that was so striking. On another interview, FDA Commissioner Makary stated, quote, tragically, tens of millions of women, tens of millions, think of that. Have been denied the life changing and long term health benefits of hormone replacement therapy because of a medical dogma rooted in distortion of risk. Now, did notice that for the first time. Now every time before this, hormone therapy always had the caveat of if the patient accepts risks. Now with this statement from Makary, notice it says long term health benefits. Amazing. We know that this prevents cognitive decline. We know that it potentially, if taken correctly, can ward off Alzheimer's. We know what it can do for cardio protection. Again, if taken correctly and even for bone health. This is remarkable. So again, I just want to state the obvious history making right now with this new hormone replacement therapy, HRT change. And we're going to get into this right after the quick break. This is Dr. Chapa's OBGYN no Spin podcast. Yep. This is why I love our podcast community. I'm going to give a quick shout out to a good buddy of mine who is with OB hospitalist group who sent me a quick message earlier in the morning. Michael, when do we, when do we actually, I know we covered this recently. It wasn't long ago on August 15, 2020. August 15th. So August 15th we covered why we had to remove the black box warning. Awesome. August 15th. So we've been talking about this. This morning I was getting ready, I was doing some other things. Boom. I get a little text from Dr. Colton. Eric, a good buddy, he's like, hey, the FDA thing, it's happening with the black box warning on menopause. I'm like, brother, love it. Do you all see how we work with this community? I mean our podcast family, guys, I think encouragement breeds encouragement. I think we hold each other to a higher level of evidence based data and care. Eric has sent a variety of great comments. We actually mentioned he was actually part of an episode a couple of weeks back, something we had discussed. I'm like, hey, go on to the episode. And I love this how we build up each other as we serve to take care of our communities in the best way possible. So thank you, Eric for sending that little message. Hey, FDA did move on this thing with the black box warning and. Yeah, and that's why we're covering this. The original data that was presented was on August 15, 2025. You got to go back. We're not going to, you know, redissect that. But all to say, it's in the archive and you got to go in there because we went to the basis of that FDA panel and the specifics and pulled out the data that now FDA commissioner said, yep, it's time to change. Because tens of millions of women have, quote, been denied the life changing and long term health benefits end quote of hrt. I love it, I love it, I love it. So very quickly, what are they going to do? They're going to remove the issue on stroke, remove the black box. Fear the wording over breast cancer and heart attack in addition to a lot of just rewording kind of the package insert for this medication. This is great. This is. It's about time. Because the breast cancer data was messed up. Messed up. According to the whi, it was bad data. And according to updated evidence, we know that, quote, there has not been a. Statistically there has. I'm sorry, let me say that again. I'm trying to get a lot of words out here quickly. Quote, the study has found a statistically non significant increase in the risk of breast cancer diagnosis. Want to be very clear. A statistically non significant increase in the risk of breast cancer diagnosis, end quote. So this is why words get kind of confusing and people get things out of whack is do some women on HRT get breast cancer? Of course. Women without HRT gets breast cancer. And that's the catch, is taking this somehow point fuel on a fire. I'll be very clear. Quote, the updated evidence shows a statistically non significant increase in the risk of breast cancer diagnosis, end quote. That is good news. That is why that is being removed and why the panel is that men in front of the FDA universally called for a stopping, a cease and desist, if you will, of the breast cancer fear in the general population among HRT recipients. Now, the one thing that is not going to change. All right, so the thing that is going to change is going to remove the reference to cardiovascular disease, to breast cancer. There it is. And the issue of dementia, in other words, of making it worse. Because we know now that it has actually protective mechanisms for cognitive decline when Used appropriately. And you got to go back to our previous episode and listen to the data to get into it now. Now what the FDA is not likely going to do and it's not on its agenda, quote, it is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen alone products, end quote. To which every healthcare practitioner goes, duh. I mean, that's real. If you take estrogen only, you should have a black box warning that that is going to make the uterus do weird things. Okay, you need endometrial protection for estrogen only products. So that's good. That should never go away. But the other issues, mainly the fear of breast cancer diagnosis and that big black box warning that says, hey, it's up to you, honey, if you want to take this, it's up to you. That's going away because the long term benefits are very well established. I'm not going to get into those. We already covered all of those in the past. And the data again was on August 15, 2025. You want to go back and listen to that? But if you listen to the press conference from ahs, it was so inspiring, honestly, as inspiring as a bunch of bureaucrats can be because finally they're saying that was not good evidence that that had issues. And if you actually take a look at the data based on age, it's okay. It's okay. So this is great. I love it. I'm all for it. Just wanted to, to put this out there that what we had reviewed in August is now a thing in November, specifically November 10, 2025. Now I do want to give some specific numbers that were referenced in all of these commentaries about the benefits. I gotta say this again, but the benefits of hrt, not just an overall hot flash relief, but a better sleep quality. But specifically in regards to cardiovascular protection, Alzheimer's protection and of course bone fracture protection, which we all get. So according to the data. Okay, so then I'm reading directly here from the commentary from hhs. All right, so this is from hhs Advances in women's health. So here it is. Very quickly, quote, randomized studies show that women who initiate hrt. Here's the catch, guys. You got to do it right within 10 years of the onset of menopause, which is generally before the age of 60, have a reduction in all cause mortality and fractures. So let's stop there already. That's a win. That is a win. Because all cause mortality, those number goes down. That should be a game changer. Game on. Right? There it goes on to say women may also reduce the risk of cardiovascular disease by as much as 50%, Alzheimer's disease by 35% and bone fractures by 50 to 60%. End quote. Phenomenal. Phenomenal. Phenomenal. So this is a good news. Again. Just wanted to put this out there. You can look. I'll put the link for hhs, of course, in these quick show notes because this is great. So again, a little quick blurb. This is a big deal for gynecology. Gynecology, our field is getting some good news and some good attention for a change. And this is phenomenal. And they're also made a promise or a commitment to look at other non hormonal options for vasomotor relief, which we have also covered in this show in the past. Podcast family who's only let you know what's going on. Cause I got to get back to what I'm doing on November 10, 2025. The FDA has now agreed and will remove the black box warning on hormone replacement therapy. It's a big day on November 10, 2025. Now that we've done all that, I got to get back to work and let's take it home. This has been Dr. Chapa Zobichi one y n no spin Podcast Podcast family, thank you for your support. Thank you for listening. And as always, we'll see you on another episode of the no Spin Podcast. It.