Ep. 518 Finally! The FDA Fix That Could Transform Hormone Therapy Safety & Confidence

It’s Nurse Practitioners Week, and today, we have a special episode to highlight a historic moment in time.

On November 11, the FDA changed the labeling on hormone replacement therapy. 

Join me for a short, focused episode where I read a recently published JAMA article detailing those changes, to keep you up to date on this significant development.

IN THIS EPISODE, YOU WILL LEARN:

• How recent FDA updates are changing menopausal hormone therapy

• The history of estrogen’s role in heart and bone health

• How past research sparked fear around hormone therapy

• What the new labeling means for patients and prescribers

• How individualized treatment is reshaping dosage and timing decisions.

• Updated FDA labeling now distinguishes between systemic and topical therapies

• Key considerations for menopause-related urinary and genital health

• How these updates will potentially impact women’s long-term health

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“If you have a uterus, you need progesterone with estrogen.”

– Cynthia Thurlow

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Transcript:

Cynthia Thurlow: [00:00:02] Welcome to Everyday Wellness Podcast. I'm your host, Nurse Practitioner Cynthia Thurlow. This podcast is designed to educate, empower and inspire you to achieve your health and wellness goals. My goal and intent is to provide you with the best content and conversations from leaders in the health and wellness industry each week and impact over a million lives.

[00:00:29] This is Updated Labeling for Menopausal Hormone Therapy. Martin Makary is the primary physician listed on this and it says the role of estrogen replacement for perimenopausal and menopausal women has been the subject of controversy. In the mid 20th century, clinicians observed that women who underwent bilateral oophorectomy before menopause-- that means they had a total abdominal hysterectomy, bilateral oophorectomy means they had their ovaries removed before menopause, faced heightened cardiovascular disease risk, suggesting that estrogen may have cardioprotective effects. 

[00.01:06] In 1942, the U.S. Food and Drug Administration approved the first formulation for the treatment of menopausal symptoms. Current evidence suggests that hormone therapy initiated within a decade of the onset of perimenopause, has been associated with numerous long-term health benefits including reduced vasomotor symptoms without significantly affecting atherosclerotic cardiovascular disease, heart disease among younger menopausal women age 50 to 59. Remember that heart disease is the number one killer of women, one in three.

[00:01:37] Hormone therapy has also been associated with a 25% to 50% reduction in fatal cardiovascular events, the leading cause of death in women. I'll just reaffirm that. A 50% to 60% reduction in bone fractures. That's why estradiol therapy is primary prevention for osteoporosis. A 64% reduction in cognitive decline and a 35% decreased risk of Alzheimer's.

[00.02:03] Currently there are more than 20 estrogen alone and combined estrogen progestogen products in various doses and forms and with the exceptions of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy. This is-- I'm getting chills as I'm saying this. I hope that you are feeling as excited as I am that we are finally getting repeal of these black box warnings on hormone replacement therapy.

[00:02:40] I think it's really significant. Hormone therapy is also approved to treat moderate-to-severe menopausal symptoms such as hot flashes and night sweats that could lead to insomnia, sleep disruption, and mood changes and it specifically states following the release of the findings from the 2002 Women's Health Initiative, hormone therapy prescriptions decreased due to fears that hormone therapy, increased a women's risk of dying of breast cancer.

[00:03:09] I was a baby Nurse Practitioner back then. I remember it well. The increased risk in breast cancer cases observed in the original study was one additional non-fatal breast cancer diagnosis per 1000 women treated in a year and it has subsequently been recognized to be attributable to the particular progesterone formulation used in the study, which is a progestin. It's synthetic progesterone. It's called medroxyprogesterone acetate, not the same as progesterone, a formulation that is not in common use today for hormone therapy.

[00:03:43] And so, I think that this is really exciting because it has really been a grassroots effort. I would like to give credit to many of the gyns and internal medicine docs and urologists, Dr. Kelly Casperson, Dr. Vonda Wright, Dr. Heather Hirsch, Dr. Rachel Rubin, many other talented clinicians that have really been at the forefront of getting this reversed and the FDA hormone therapy label updates include removal of the box warnings which previously fear mongered about cardiovascular disease, stroke, breast cancer, and probable dementia except for the box warning and systemic estrogen labels for endometrial cancer with unopposed estrogen in women with a uterus, completely appropriate, as it is important to remind practitioners that if you have an intact uterus and you are taking estrogen, you also need progesterone to balance out the effects. It also removed the recommendation to prescribe hormone therapy at the lowest effective dose for the shortest duration. We know that is not standard of care.

[00:04:51] We know that treatment decisions absolutely need a bio-individual approach and with the clinical judgment and expertise of the prescriber. I'm going to reemphasize the word prescriber. If you cannot prescribe menopausal hormone replacement or perimenopausal hormone replacement. I'm not suggesting you can't have an opinion. I'm just stating, if you are not a prescriber and you are listening to this, please go to your prescriber so that they can counsel you on risk, benefits, shared consent, etc.

[00:05:23] In its place there will now be tailored safety information. Instead of applying identical class-based language across all hormone therapy labels, safety data will be revised to reflect risk most relevant to each specific type of hormone therapy, meaning just estrogen, just progesterone, and combined therapies.

[00.05:41] For the topical vaginal estrogen only drug label, the emphasis is on the safety findings most relevant to topical vaginal use and not the broader warnings associated with systemic exposure. It is based on what I know of the science that intravaginal estrogen, or whether it's compounded intravaginal estrogen plus or minus DHEA and testosterone, tends to stay localized, very different than taking oral estrogen, very different than taking transdermal estrogen.

[00:06:10] And we know the timing information for hormone replacement. It says labels will include updated guidance on initiating treatment in women younger than 60 or within 10 years of menopause. So, obviously there's this optimal window. That doesn't mean that I have not met many women who were more than 10 years out, had a very extensive cardiovascular risk evaluation and were prescribed systemic hormones, not just intravaginal.

[00.06:36] Every single woman listening will eventually develop genitourinary syndrome of menopause or GSM as we like to call it. You may not need vaginal estrogen or vaginal estrogen plus or minus DHEA and testosterone right now, but eventually you will. That's what the statistics demonstrate and show. I find with some of my thinner patients, they need it sooner rather than later. I jokingly say that's another thing they'll have to pull out of my cold dead hands. I will not ever give it up, and I take a product that is compounded and has two forms of estrogen as well as testosterone and a little bit of DHEA and that helps with the muscular layer.

[00:07:16] One thing I think is really interesting is that many women are told they're more than 10 years out, there's nothing they can do. This is why it's important to see a practitioner who is well informed on not only menopausal care, but also assessing for risk stratification. So, tomorrow, which is Wednesday, I will be dropping a podcast talking about heart disease risk and a lot of the questions that came in with the podcast with Dr. Dayspring that I didn't answer there, that I answered just as a solo podcast and the types of things that I think about is someone with a very lengthy cardiovascular background. Number one, ApoB, Lp (a), what's your fasting insulin like? Really getting granular about metabolic health and then turning the conversation to cardiovascular risk evaluation. Yes, you could do a CAC, coronary artery calcification, you could do a CT angio.

[00:08:10] But I think the Cleerly Lab is AI generated CT angio. I think that is going to be a better bet. It is not yet covered by insurance. Talk to your practitioner, talk to your provider, if that is available to you in your area. That is something that I've gotten very interested in because it looks at hard and soft plaque and it's a little bit more diagnostic.

[00:08:32] Having said that, again to reaffirm what was already stated, the hope is that by reversing these labeling errors that were made previously that it will address this longstanding fear both by prescribers and patients. It’s my mother's generation, our mother's generation that was so impacted by the WHI, and I'm so glad that it's our generation that is making it better for future generations.

[00.09:02] One thing that I think is really important is that when we really look at the statistics of how many women are going into menopause on a yearly basis, not just in the United States, but globally, I think these types of conversations are critically important. I hope that you will take this information and we will put links in the show notes to this direct JAMA article again called Updated Labeling for Menopausal Hormone Therapy. You can also grab it online.

[00:09:28] Martin A. Makary is the physician that has really been at the spear front of this. I'm so, so grateful. It's a really well-informed article. It was published on November 10, which ironically enough is Nurse Practitioner Week.

[00:09:43] So, this is a short and sweet episode on Friday. This is what's keeping me interested and engaged and wanted to make sure you all were aware of these updates. I think it's really exciting. Hopefully this will be published on November 14, which is Friday, so it'll go nicely with your weekend. Short and sweet. Enjoy the episode. Hope to be doing more of these moving forward.

[00:10:09] If you love this podcast episode, please leave a rating and review. Subscribe and tell a friend.

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