CEimpact Podcast

FDA Removes Boxed Warnings on Menopausal Hormone Therapy

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Menopausal hormone therapy has long carried a boxed warning (formerly a "black box warning") that may not accurately reflect the therapy's risk-benefit profile for all patients. This course discusses the FDA's recent removal of boxed warnings for select hormone therapy (HT) products, the rationale for this change, and how evolving guidance may impact patient care. You will explore strategies to support evidence-based counseling and individualized decision-making for patients considering HT.

HOST
Rachel Maynard, PharmD
GameChangers Podcast Host and Clinical Editor, CEimpact
Lead Editor, Pyrls

GUEST
Erin Raney, PharmD
Professor
Midwestern University College of Pharmacy


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Purchase the Clinical Update Series or this course individually to receive the exclusive downloadable practice resource handout to use as a reference guide to the podcast.

 
CPE REDEMPTION
This course is accredited for continuing pharmacy education! Click the link below that applies to you to take the exam and evaluation:


 CPE INFORMATION
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Summarize the FDA's updated position on boxed warnings for menopausal hormone therapy.
2. Identify key considerations for pharmacists when counseling patients about the benefits and risks of hormone therapy.

Rachel Maynard and Erin Raney have no relevant financial relationships with ineligible companies to disclose.

0.075 CEU/0.75 Hr
UAN: 0107-0000-26-044-H01-P
Initial release date: 1/26/2026
Expiration date: 1/26/2027
Additional CPE details can be found here.

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SPEAKER_00:

Here on Game Changers, we're all about helping you stay ahead of pharmacy practice. But why stop at listening? You can earn CE credit for this episode and hundreds more by visiting CEimpact.com and logging into your account or creating a new one. Get credit, get inspired, and make your learning count. Hey CE Impact subscribers, and welcome to the Game Changers Clinical Update Podcast. I'm your host, Rachel Maynard, and our topic today is one that I think will be very interesting to discuss. So recently, the U.S. Department of Health and Human Services announced that the FDA is initiating the removal of broad black box warnings from menopausal hormone therapy products, sometimes called hormone replacement therapy. And this is part of a swinging pendulum that's been happening over decades, and this labeling change has been called years in the making from some leading organizations. So today we're going to sort through all of that noise and headlines. We're going to discuss why hormone therapy has a complex history. We'll clarify what FDA has recently done and why, and we'll come to a bottom line on how we as pharmacists can support patients with evidence-based and individualized decision making. So to help shed light on this topic, I'm so excited to introduce our guest today, Dr. Erin Rainey. So welcome, Erin. Thank you. I'm excited as well. Excellent. Well, Erin, maybe you could share a little bit about your background, your current role, and why you're interested in this topic.

SPEAKER_01:

Yeah, great. As I mentioned, I'm really excited to be talking about this topic. I am a professor of pharmacy practice at Midwestern University in our Glendale campus. And over my career, since 1998, I've had a role in academia. I've had an interest in endocrinology and had clinical practice in family medicine, but I've also taught endocrine topics for those years and continue to here at Midwestern. And as I have had this love for reproductive health care and endocrine topics, I have had output in clinical practice, but also in scholarly work as well. So this is my wheelhouse, and it is great to be here to talk about it.

SPEAKER_00:

Fantastic. Well, thank you so much for your time. I know you've got a busy schedule, so really appreciate you joining us today. And I just love that you brought up 1998 as the year that you sort of have been seeing this through all of the changes that have evolved over the last few decades. And so I think to help put this most recent change in perspective, it'd be really helpful to understand the history that sort of led us here. And I mentioned that pendulum sort of swinging back and forth over the decades. So could you give us an overview of the change in thinking that we've seen with hormone therapy over time and just sort of that historical background?

SPEAKER_01:

Yeah, if anything is beneficial about being around so long, I can provide a historical perspective. Hormone therapy for menopause has was popular in the 1940s, 50s, and women were receiving benefit all the way back then from estrogen. There was a concern in the 1970s when they realized, oh, when we give estrogen to a woman with a uterus, she gets endometrial cancer. So that caused increased information about needing a progestin added to an estrogen in women who had a uterus. So we proceed into the 1980s, and there is common use of estrogens with or without progestins for hormone therapy at menopause, and a recognition that perhaps even giving that therapy lifelong through menopause and postmenopause would provide some chronic disease prevention benefits, things like heart disease reduction, osteoporosis prevention, even cognitive benefits.

SPEAKER_00:

With that, pause for a second there. So in the 80s timeframe that you're mentioning, it was estrogen therapy, hormone therapy was being used to help manage menopausal symptoms specifically. It was not being used for chronic disease prevention at that point. It was being used for menopausal symptoms. Is that right?

SPEAKER_01:

Yeah, it was being used for symptom management, but noticing that this could be the need to replace hormones. That's where the HRT came from that were missing post-menopause and to really put a woman into a pre-menopausal state again with not only symptom benefit, but long-term benefit was the expectation at that time. There were observational studies that were showing some of that benefit. And in the 90s, early 90s, the Women's Health Initiative was created to enroll individuals for a long-term period of time in a randomized control setting to really test that hypothesis that when women receive hormone therapy, that they will have a reduction in coronary heart disease risk, they will have a reduction in osteoprotic fractures, and really test that theory. So that was the reason that the WHI was born in the 90s. Excellent. So there were dietary interventions, calcium and vitamin D, and the intent of also an observational trial longitudinally as well. And so as we have our discussion, I think we'll talk about the WHI in a lot of frameworks. But what we are most interested in, I think, in right now, is looking at those hormone therapy trials that were the RCTs. They enrolled individuals through 1998. And then as we know, in the 2002 year, when I was prepping menopause lectures very routinely after teaching this topic to pharmacy students for several years, the menopause world turned upside down because there was evidence in the estrogen progestin arm that was our conjugated equine estrogens with madroxy progesterone orally, that there wasn't evidence that there was the CHD risk reduction. In fact, there is trending towards an increased risk along with increased stroke and VTE or thromboembolic events. But then also what was shown is increased incidence of breast cancer. So that arm of the trial was halted in 2002. We had the trial that involved estrogen-only arm that continued a couple years longer than that, 2004. And the reason that that happened was although there was some evidence of increased strokes, there wasn't that breast cancer increased risk. In fact, there was an evidence towards a lower risk. There still wasn't that CHD risk reduction that was expected. And that's why that one was halted in 2004, a year earlier than intended.

SPEAKER_00:

Excellent summary. So now, once we had that initial data from the WHI, what was the response to that? And what did women, clinicians, what did we all take away from that?

SPEAKER_01:

Yeah, so it was a really important time to take take the consequences of these findings and move forward with that. I can't imagine what it would have been like if we had social media at that time. There was no social media. But you're regardless, there was a lot of fear. Patients were worried, clinicians were worried, as you mentioned. What do we do with these findings? Because it was never intended that administration of hormone therapy would cause harm, right? The intent was that it would be helpful in all ways. So broadly, what we saw was a dramatic decrease in hormone therapy prescriptions that would be expected on both the patient and clinician part, that fear that I was speaking about. And then a movement or a change from FDA on product labeling. And so at that point, there was a very broad brush approach to changing and adding a boxed warning to all hormone therapy products used for menopause, estrogen and progestin products, even those that were not studied in the WHI. So all forms, routes of administration, oral, vaginal, transdermal. And that boxed warning summarized the WHI findings at that time, indicated that there was risk in terms of venous thromboembolism, the breast cancer risk with the combo therapy, as well as heart disease risk. And then, if I might just read even from the labeling, a statement that in the absence of comparable data, these risks should be assumed to be similar for other doses of the products and other combinations and dosage forms. So that was explicitly stated in the boxed warning, and that they the products should only be used at the lowest effective doses for the shortest duration of time. So that was the boxed labeling that was added, the boxed warning across the board. And that literally has not changed since then, even though there's lots of new data that somewhere.

SPEAKER_00:

Okay. Okay. Yeah. So that's a really important point, I think. The fact that you said this was applied in res this boxed warning was applied to the labeling in response to WHI data and applied across the board to all the various forms of hormone therapy. And so I think that's a good opportunity to actually just dig a little bit deeper into those various hormone therapy products because you did mention oral versus transgermal versus vaginal. And so help us just get on the same page about what those different forms are and maybe some of the risks that may or may not exist with each product, each type of product, and based on what we know and don't know from WHI.

SPEAKER_01:

Yeah. So just to give kind of a background, put us all on the same page here. We know that the estrogen component of hormone therapy is going to provide that benefit for menopause symptoms. Now we can categorize those as vasomotor symptoms like hot flashes, but also vulvo-vaginal symptoms or genitourinary syndrome of menopause or GSM. And those are very different presentations of symptoms that would relate back to different routes of administration of estrogen. So with estrogens, we have the oral, the transdermal, which could be in a patch form, it could be a topical gel. Then we have vaginal administration in the many different forms, vaginal tablets, vaginal rings, creams, other formulations that can be compounded. So we have lots of opportunity with estrogens in that way. The progestin, we have oral formulations, there's a combination patch, but for the most part, we have a less opportunity for the routes of administration with progestins. But within both categories, there's different chemical formulations. So we have the conjugated equine estrogens, which were studied in the WHI, but then there's bioidentical estradiol, which is available in commercial and compounded formulations. We have hydroxy progesterone, which is the progestin that was studied in the WHI, but we also have bioidentical progesterone, which comes in a micronized form, and that also either commercially available or compounded. There are others as well, but that just gives kind of that broad overview and reminder of the vast options that we have, thinking back to one boxed warning that is applied across all of those.

SPEAKER_00:

Right, right. Okay, great clarification there. And just to recap the point you made earlier about the progestines, when are the progestines needed, if being used for hormone therapy in combination with the estrogen? And what is the risk-benefit consideration there? You could just summarize that again.

SPEAKER_01:

Yeah, the the issue with estrogen that's unopposed is that when someone has an alliguterus, then that endometrial lining, we can have hyperplasia and a risk for endometrial cancer. What we know is that we can administer progesterone or progestin along with the estrogen that prevents that hyperplasia and reduces the endometrial cancer risk back to baseline. We have to be careful not to say zero because there might be an additional risk for cancer that a patient has. When we do that, we can either give it in a daily dose or in a sequential dose, which might be 12 to 14 days each month. But that provides that protection. Now, to get on to another topic, we don't only have to use a progestin. There's a CERM or a selective estrogen receptor modulator, vasodoxifine, that also provides that protection. That's in a completely different product. But overall, when a woman has a uterus, then we want to protect that endometrial lining. And the way to do that best would be with the estrogen in combination with a progestin.

SPEAKER_00:

Okay, excellent. Again, great summary and orienting us. And I do appreciate that you mentioned, you know, we're focusing on hormone therapy in this discussion, but there are other therapies that may be used to help manage menopausal symptoms that we're not really going to be able to address in much detail today, but good to be aware of other options as well. And narrowing in on our hormone therapy, thinking about some of these recent changes from FDA. Let's talk now about what those recent labeling changes are, what prompted this change. And there's quite a lot of nuance in terms of what was removed, what wasn't removed, how it affected various products. So that's why that overview you gave of the local versus systemic is so important. So let's dive into that a bit more.

SPEAKER_01:

Yeah, so as we think about the recommendations just in last fall for labeling changes, I do want to provide the perspective that this is not a new request or something that has just come up in 2025. The experts in menopause care have been requesting a labeling change for the last 20 years since the WHI, specifically for the vaginal estrogens, which we know are not, except for one product, there is one vaginal ring that is intended for systemic absorption. That's the estradiol acetate ring. The other vaginal products don't provide this excess serum estrogen level that would be anything different than our postmenopausal level. And so all along past decades, even petitions to FDA have been denied for labeling changes in on those products. So in the the changes that happened when it came out as the announcement, the change to label uh the labels for vaginal estrogens has been applauded by pretty uh universally. And that would be removing the WHI data that was not related to vaginal estrogens from the from a boxed warning there and only having in the vaginal products the intent the summary of studies that were of vaginal estrogens. Um so that is that side of things. Now, as we look at the systemic therapies, there's also a recommendation to remove the components of the boxed warning for all systemic products, whether it is oral or transdermal, and also vaginal, as I mentioned, related to risks for heart disease, breast cancer, et cetera, that occurred from the WHI initial data. Um, those that removal will be across all products. There's a recommendation to add some language about preferentially considering hormone therapy for vasomotor symptoms in individuals who are within 10 years of menopause under 60 years old. That will be something that is might be added to the labeling there. And then making sure to retain the language that confirms that endometrial cancer risk is real if we don't provide that progestin with the estrogen for women who have a uterus. So that that's kind of some of the language that's expected to change in the product labeling.

SPEAKER_00:

Excellent. So just to narrow in on one of those changes, which I think is really important and we can tie back to the WHI data a bit, is that that addition of the consideration of starting home therapy for moderate to severe vasomotor symptoms in women less than six years old or within 10 years since menopause. Maybe we can dig into that a little bit more because this timing consideration I think is an important one to be aware of.

SPEAKER_01:

Yeah, so I think one of the things that came out right away in 2002 and 2004 is this interest from researchers and why why was this, why were these results seen? What was happening here? And notably the the WHI was enrolling participants to look at cardiovascular health and and fracture risk reduction, and needed a population that would have event rates that would be they'd be able to show a reduction in for an RCT, as we know from our study design. So the intent of that study was not to um evaluate women only in their early menopausal years who for symptom management. They already knew that it helped with phasomotor symptoms at that time. Because of that, then the initial WHI data that was included in the box labeling, boxed warning, only summarized what was initially reported in 2002 and 2004, which is all of that cohort of women 50 to 79. What were the outcomes that were seen there? Now, subsequent to that, then there was a lot of interest in looking at this timing. What about happened to women in that first decade post-menopause, second decade, third decade, was there any difference in this? And that was significant in terms of seeing some unique findings where the cardiovascular risks were and the breast cancer risk were minimized in those early years and more available and evident in the later years. That's the general trend. Now, if we look at each type of risk, there's nuance there. So as the research has developed over the last 20 years, not just the WHI findings, but also many other researchers who are looking at transdermal estrogens or vaginal estrogens or different estradiol versus conjugated estrogens, it has been very important to identify what age group are we studying here? Is it intended that we're looking at newly menopausal individuals who are having vasomotor symptoms or symptoms of menopause? And how does that translate to risk? What has been fairly consistent? And if we look at guidance documents from these expert groups, there is a general guidance that the lowest risk time to use hormone therapy is in that less than 60 years, first 10 years of natural menopause. That is one thing that seems to have a general agreement upon. And so having that part of the language and the product labeling is kind of where that's coming from. But it was not digested in that way in the initial reporting of the results in 2002 and 2004. It was all the 50 to 79-year-old data.

SPEAKER_00:

Right, right. So important distinction there. I think the the recurring theme that will probably come through in this discussion is individualizing care. And so age and onset since when they had menopause, those are very important factors to be considering when thinking about the risk-benefit evaluation for a given patient. One other thing I thought was interesting about the labeling change that is being made is the removal of the recommendation to use the lowest effective dose for the shortest amount of time. What are your thoughts on that? Because, you know, with any sort of therapy, regardless of what we're talking about, reevaluation and you know, following up the patient, reassessment seems to be something that. We want to be considering all the time. What is your your professional stance on that or your take on that change and removing that wording? Yeah, I think that's what would you summarize the organization's stance on?

SPEAKER_01:

Yeah, I think that's really important to consider. One thing that I want to highlight here is that in these studies of the individuals in those earlier years, post-menopause, we want to consider that this doesn't reflect on risk with individuals that have had premature menopause, less than 40 or less than 45. Less than 40 is called primary ovarian insufficiency. There's a completely different risk profile for those individuals. So we are talking about our natural menopause, average age in the US, 53, you know, that that type of age group when we discuss this. Shortest period of time and lowest effective dose seems pretty reasonable, doesn't it? But one of the things that we want to consider is that this is one of the areas that I think is the most controversial that is coming out of this labeling change. Because we need to remind ourselves that when we look at the WHI data, those individuals in the study received hormones for between five to seven years, depending on which arm they were in. And the follow-up that we have 13 years, 17 years, 20 years. Now we'll have 25-year data. That is not of 20 persistent years of hormones. That is of receiving hormones for five to seven years when you're in your early 50s, and then what happens 20 years later? There isn't this longitudinal data set of what happens when we even start at age 50 or 52 and then continue to use therapy until 70, 80, 90. So with that, with that lack of data, what is supposed and recommended with the expert societies is that they don't recommend any certain age as a cutoff for hormone therapy. There is very clear support for considering continuing therapy into the 60s or beyond, but it has to involve all of this individualized risk assessment. So I think what the experts are saying, and I agree with, is that you can take a 54-year-old who has higher cardiovascular risk than some 60 or 70-year-olds, that we don't want to only limit it to age. We want to consider that risk. So I guess from my my standpoint, I like the idea of with any medication, let's use the lowest effective dose. But the shortest period of time, really not so much thinking that it has to be at age 60, we have to stop, but considering that that what we need to do is make sure there's consistent evaluation. And this is not a one and done. We are not evaluating a woman at age 52 and saying, here you go, have hormones the rest of your life. We were saying, let's evaluate your 52, 53, 54, 55. And it is it is time intensive. And wow, we deserve it, right? That is the important thing that comes out of all of this. So I guess that's my my thought. And really, you'll see it if you read the guidance documents from International Menopause Society, the menopause society here in the states. They all agree that let this be a shared decision with the patient and not only age-based.

SPEAKER_00:

Because patients going through having menopausal symptoms, they may have them for years, right? I mean, from 50 up until 60s or up until 70, is that common?

SPEAKER_01:

Yeah. So actually I'm glad you asked about that because this is where it becomes really important and actually pretty exciting to think about symptoms of menopause with vasomotor symptoms, tend to start like hot flashes, tend to start in the perimenopause or menopause transition, and then continue into early menopause, with most women having the uh waning of symptoms over time, although there are women who have vasomotor symptoms into their 70s and 80s. The other side of things, that vulvo-vaginal atrophy, the genital urinary symptoms, that those genital and urinary tissues are susceptible to lack of estrogen lifelong. And it actually worsens over time with aging. So when we can really fine-tune this to a decision, what is what is our patient experiencing for vasomotor symptoms and systemic estrogen that's needed for that? That might be one line of thinking in terms of how long the therapy is is beneficial. But then we have these, the local vaginal genital and urinary symptoms that this is why it's so important to delineate the vaginal estrogens and that the low local low dose might be something that's used for a very long time in an individual. And and to make sure that we're keeping track of the risks uh appropriately because menopause symptoms are worsening over time with vaginal symptoms and waning over time typically with a vasomotor symptom.

SPEAKER_00:

So gotcha. Yeah, great point to clarify. And still thinking about that reassessment, like you say, every year is important, but not being necessarily alarmed if you're seeing a patient pour years on a local product because they may need that, as long as that reevaluation is happening, but they may need that, as you say, because the symptoms can continue to get worse over time with this.

SPEAKER_01:

Yes. And and another area that you'll see, and and this is why we don't want to oversimplify any of this, and why it's so exciting to just have conversations now that are very public. It's a great opportunity, is that the the nuance to individuals who might need vaginal estrogens long term might have cancer diagnoses and are cancer survivors of various types of cancer and working with oncologists to determine could those local estrogens vaginally administered be something that is absolutely necessary for quality of life. Um, so that's just one example of how how much opportunity we have to really make sure that we're bringing in the expertise for that individual, whether it's a cardiologist or an oncologist or a gynecologist, we all have different layers of risk that we bring to the table.

SPEAKER_00:

Absolutely. So I think we've got a good handle on what those FDA changes are. And as you've sort of alluded to, I think we're going to see probably a lot more interest from patients and the opportunities to have some of these discussions. So thinking about, you know, if you have a patient who's asking you as a pharmacist about what should I make of all of this news about hormone therapy? Um, is this something I should be thinking about? How do you sort of guide the patient and ask those assessment questions to determine if that risk benefit makes sense for them? What are the things that go into that decision-making process for you?

SPEAKER_01:

Yeah, so I think it with a risk benefit, what we can bring to the table as pharmacists. This is what we do best. So if we think about cardiovascular risk assessment, breast cancer risk assessment, fracture risk assessment, these are these long-term risks that we're worried about. We know how to do that. There are risk equations that we can utilize to take into account a patient's family history, their weight, their lifestyle, alcohol use, smoking status, genetic makeup, what is happening with their cardiometabolic risk or cancer risk related to all of these things, fracture risk, et cetera. When we're comprehensively looking at that, my suggestion to a patient would be what, first of all, symptoms are bothersome to you? Is it hot flashes? Is it the local vaginal symptoms or urinary symptoms? Is it both? And then suggesting that in order to know if hormone therapy is right, it very well could be, that we would need to look at this comprehensive view and look at their heart health, look at their bone health and these other risks. That will look different in everyone. It'll take time, it'll take attention, not to be fearful of it. I think we want these risks evaluated whether we're considering considering hormone therapy or not. And so to just normalize the conversation to wow, any any individual in midlife needs to be looking very carefully at all of these risks. If we're going to add hormone therapy in, let's make sure that we are we are tasked with looking at your situation only and what it looks like now, knowing that it might change in two years or 10 years, et cetera. And also emphasizing to a patient, we have lots of options. I think that's very exciting. So I guess probably a tendency for me would be to change this from fear to a positive excitement that this very well might be a great opportunity. But if it isn't, we have even more non-hormonal options than we've ever had in our toolkit. So that a patient would know, you know, if you're having bothersome symptoms, there is something that we can do to help you. This is not, can I get hormones or am I out of luck in all ways possible? That this there's hope. And that I don't think has been clear messaging for a lot of patients in the last couple of decades around menopause. If that's the outcome of all this, I I welcome that for the patient.

SPEAKER_00:

Absolutely. And so for for those patients who, you know, that that evaluation has been made and they may be starting home with therapy, systemic or local, what are some of the key counseling points that patients should be reminded of when starting any of these products? And again, let's maybe differentiate between the systemic versus local because you know there's different considerations there. And and also let's talk about transdermal too and the risk assessment with that and how that compares.

SPEAKER_01:

Yeah, so just generally to answer that first part of the question, I think in any patient counseling, we we have so many different routes of administration. So I think instructions for use is really key, right? We are administering hormones in in all different forms, and there's always an opportunity to not use these correctly, literally, in terms of the administration. Also, we need to the patient to be aware of expectation. How long will they take before there's benefit seen? And depending on the nature of the symptoms, those local vaginal symptoms, that might take. And if if the patient has had symptoms for a while and that tissue is is really friable, it might take months before there's benefit in some patients. They might see it within weeks. Vasomotor symptoms tend to respond fairly quickly within a few weeks to a few months for sure, if if they're at the right dose. So those expectations, I think, are important as well. And then also a discussion about how we will monitor that safety. So depending on the type of product they're receiving, how will we know if there's risk occurring? What are we doing to make sure that they have good cardiovascular health, that they're having cancer screenings and et cetera? I think that should be part of the conversation as well. I think I forgot the second part of your question as I was talking through all of that.

SPEAKER_00:

No, you had those great counseling points. I'm glad you touched on those. This second part was about the transdermal formulations necessarily discuss like oral forms versus transdermal and whether there's a difference in risk there. We talked about local versus systemic, but let's just dig into that a little bit further. Great, great.

SPEAKER_01:

So as the WHI data was published initially, really one of the primary findings, and we knew this already from oral contraceptives, was that there's a thromboembolic risk involved with administering exogenous estrogens. So immediately there is thought that could it be that transdermal administration of the hormones might have a different risk profile, especially related to venous thromboembolic events? And the reason is that when we absorb estrogen through the skin, it does not go through first-pass metabolism, right, being presented immediately to the liver. And so there's less of an activation of clotting factors, uh, serious protein, even triglyceride levels are not increased. And could that then confer or attenuate that risk that we see with causing blood clots or perhaps strokes? Now, over time in the last 20 years, there are studies that are leaning that way, that there appears to be a lower risk with especially venous thromboembolic events for transdermally administered estrogens. Whether there's the lower stroke risk is still being looked at, and there's a lot of interest about whether there's a difference also in the type of progestogen, which I know wasn't part of the question, but is micronized progesterone less thrombo thrombogenic than madroxy progesterone? So it's all this data is percolating and bubbling up, and it's summarized in the clinical recommendations. It is not 100% clear, and that is frustrating. We would love to have, after 20 years, one final answer, but it is leaning towards transdermal estrogen having that potential benefit in terms of like DVT, PE, etc. It doesn't appear to have a difference though, related to breast cancer. Okay, whether versus oral.

SPEAKER_00:

Okay. Okay, thank you for clarifying that. I realize we didn't chat about that specifically earlier, so I did want to touch on that. Um so I think the bottom line from what you've summarized and what the professional organizations are coming out with in response to the FDA changes is uh there is with systemic products in particular, there is risk, but it's not necessarily the same for every patient because this is such an individualized decision-making process. You need to be thinking about those patient risk factors, such as age, such as time since menopause, their personal history, their family history, sort of that broad assessment that you walked us through so nicely earlier. Um, and just a great opportunity to have those conversations and use this as an impetus to allow patients to be coming to you with questions and re-evaluating, you know, maybe patients who had ruled out hormone therapy but have been suffering from menopausal symptoms. This is an opportunity for us to re-engage in those conversations. Is there anything else you want to summarize from sort of the data or these changes or the professional organizations, any sort of other key takeaways that we may not have had a chance to discuss?

SPEAKER_01:

Well, I could talk for days about this. So, yes, lots of things. But one thing I would like to also bring attention to in doing additional reading, which I recommend for all of us, is that there are some tools emerging for assessing risk related to menopause therapy. Uh, a couple of years ago, there was a publication out of the American College of Cardiology that gave kind of a risk assessment view for heart disease risk and whether hormone therapy would be appropriate, putting people in low, intermediate, or high risk. And the low risk, you can use systemic therapy in all forms in that earlier age group, 50 to 59. If they were intermediate risk based upon the assessment, then maybe the transdermal high risk don't use, go to non-hormonal. So that kind of tool is something that I'm anticipating will continue to emerge. And we need to watch for those things because this doesn't need to be a guess. We need to be able to use these risk assessments in a way that then is supported by expert guidance and documents like that from the cardiology side. There's documents like that from the oncology side. This is what will help those assessments. But I'm just excited that there's a conversation about it. And what we don't want to do is take that the concern about the broad brush, um, simple oversimplification of risk that occurred from WHI and now have a broad brush of oversimplification that the risk was never there. That's not that's not the point. The point is let's take a deep breath, let's talk to each individual without fear and really see what's on the table for them as far as options, hormonal or non-hormonal, and and remove some of that emotion. Let's live in the gray. And I I always I tell my students, let's embrace embrace the complexity. Don't try to make this easy. The individuals that you're working with, those patients deserve that we are taking this in as a complex decision, but that's what we have our expertise in. We don't need this to be simple. So when we look at how this is all communicated, we really want to be careful that patients are aware that this is not a one size fits all in the opposite way either. Um and we need to take care, take care to look at all the data. And the data are summarized even just last month. The International Menopause Society published in December 2025 updated recommendations for care at midlife and menopause. We have the resources available. Let's dig in. We need our patients deserve that.

SPEAKER_00:

I just love how you summarized that. It just made me excited to be thinking about how what an opportunity this is to help improve care for patients and as you said, embrace it, welcome that, and encourage those discussions. I also love how you highlighted the fact that we need to stay on top of this because this will continue to change and this is something we are going to be continuing to get questions about, but also more tools and resources will be coming out about this. I really love the fact that you highlighted that there are already tools, cardiovascular risk assessment tools that can really help guide those conversations. Because I do think both with cardiovascular disease and with breast cancer, for example, you know, I people may think that these options are eliminated for them, but that's not necessarily the case, especially depending on the formulation and product you're talking about. So I just think that's a really important point. And just this idea of the pendulum maybe coming in the right, you know, in the center here a little bit more than where it was in the past decades of back and forth, maybe we're narrowing it in the center, but also not making these blanket one-size-fits-all considerations for pro or against. I just think that's such a nice takeaway for our listeners. And actually, with that, I will go ahead and ask you because it is our game changers clinical update podcast. So, what would you say is the game changer for our listeners today? What would you want them to walk away with? I think we just had a nice summary there, but maybe one more game changer for them to be thinking about.

SPEAKER_01:

I I have already probably alluded to this, but I just want to reiterate the opportunity that the care for individuals experiencing menopausal symptoms has never had a bigger toolkit. We are we are ready. And if we do our due diligence with the data and recognize that there's emerging data every month of every year that that continued investigation and digest digest that data on as good consumers of data would, that that is what the opportunity brings. Whether or not there is a change in the warning label on the product. Is not really the game changer to me. The game changer is that these concepts were known all along. The guidelines have always talked about these individualized risk assessments. It's just opened up the discussion to be something that I think experts have been asking for for decades. And now we have that opportunity, but it is not straightforward and easy. As humans are not.

SPEAKER_00:

Of course not. And I love how you said too, like, live in the gray. This is nothing is black and white when it comes to caring for patients. It would be great if it was, because obviously that would make things very easy, but that's why we're here and we're empowering our ability to care for patients and really individualize that thought process. So I just love that you summarized that so well. And thank you so much, Erin, for your expertise today. I just really appreciated hearing, especially your personal perspective from that start of all of this and where we are now. There's been a lot of evolving evidence, and it's just great to hear you summarize it as you did. So thank you so much for your time.

SPEAKER_01:

Well, thank you for the opportunity. I I really appreciate it. And I'm learning every day myself. So I'm I'm we are all in the boat together. So it's it's a really exciting time. Fantastic.

SPEAKER_00:

Thank you so much. Thanks. So, listeners, be sure to claim your CE credit for this episode of Game Changers by logging in at CEimpact.com. And as always, have a great week and keep learning. I can't wait to dig into another game changing topic with you all next week.