Erica Marnatti, an APRN and Menopause Society Certified Practitioner in UK HealthCare's Women’s Health Internal Medicine Clinic, joins the show to discuss the recent lifting of "black box" warnings on hormone replacement therapy.
Menopausal HRT 'Black Box' Warnings Are Going Away. What's That Mean?
Erica Marnatti, APRN, MSCP
Erica Marnatti, APRN, MSCP, is an APRN and Menopause Society Certified Practitioner in UK HealthCare's Women’s Health Internal Medicine Clinic.
Menopausal HRT 'Black Box' Warnings Are Going Away. What's That Mean?
Maggie McKay (Host): Welcome to UK HealthCast, a podcast presented by UK HealthCare. I'm your host, Maggie McKay. Joining us is Erica Marnatti, APRN and Menopause Society-certified practitioner in UK HealthCare's Women's Health Internal Medicine Clinic, to discuss the recent lift of warnings on hormone replacement therapy.
Erica Marnatti, APRN, MSCP: Thank you so much for having me today.
Host: So, what does the FDA's removal of the black box warning actually mean for women?
Erica Marnatti, APRN, MSCP: Well, this is a really big deal, because the FDA finally removed an outdated warning that scared a lot of women and providers from prescribing hormone therapy. What it really means is that women can start making decisions based on the updated science instead of old fear. It doesn't mean that hormone therapy is perfect for everyone. We still are individualizing it based on age, timing, and health history. But overall, this opens the door for more women to consider treatment if they're good candidates, and it gives providers a lot more confidence to have these conversations. Again.
Host: That's great. Why did the FDA place the black box warning in the first place?
Erica Marnatti, APRN, MSCP: Well, it all goes back to the early results of the Women's Health Initiative in 2002. The headlines at the time made it sound like hormone therapy drastically increased risk for heart disease, stroke, blood clots, and breast cancer. So, the FDA added the strongest warning they had, the black box warning, and the use of hormone therapy dropped almost overnight. Women literally flushed their hormones down the toilet. But here's the catch. The average age of women in the WHI was 63. Most were over 10 years past menopause when they started hormone therapy. And this study used older synthetic hormones, which is different than what we typically use today, which are the bioidentical estradiol, and progesterone. When experts went back and they reanalyzed the data, it became clear that the risks were much more nuanced, but it was too late. The media had taken the information and ran with it, causing widespread fear and misinformation.
Host: How do the black box warning make women and providers feel?
Erica Marnatti, APRN, MSCP: The black box warning made women feel scared, confused, and even ashamed for considering hormone therapy. It created a sense that hormones were essentially off limits, even for women who could have genuinely benefited from them. A lot of women felt dismissed or unsupported because their providers were reluctant to prescribe hormone therapy. And their symptoms were often minimized instead of treated. For many, it felt like the door to treatment had been closed, leaving them to just cope on their own.
Host: Wow. What impact did this have on women for the last 20 years?
Erica Marnatti, APRN, MSCP: Well, the impact has been enormous. We now have a whole generation of providers who weren't trained in menopause care, largely because hormone therapy became so stigmatized. And as a result, too many women were dismissed or told that this is just part of aging. Instead of being offered hormone therapy, many were prescribed antidepressants. Even something as simple and safe as low dose vaginal estrogen, which doesn't absorb systemically, has been very under prescribed because the black box warning has even been applied to it. Women are struggling with severe vaginal dryness or recurrent UTIs and have often gone without effective treatment due to the fear surrounding the hormones.
So meanwhile, the women are continuing to have to cope with common menopause symptoms like hot flashes, night sweats, insomnia, mood swings, low libido, and fatigue. And it's not just about symptom relief. Estrogen plays a critical role in long-term health. It protects the heart, it maintains bone density, and it supports cognitive function. So for many women, missing out on hormone therapy has meant both ongoing daily discomfort and lost opportunities to protect their long-term health.
Host: Will this change the way you practice at Women's Health?
Erica Marnatti, APRN, MSCP: Well, since Dr. Beshear opened the menopause clinic last summer, we've been following the latest evidence-based guidelines. So, this change doesn't really change how we currently approach care. We focus on each woman's individual health history. We talk openly about risks and benefits and make sure screenings like mammograms are up to date. We also remind women that some risks like breast cancer exist independently of hormone therapy. And at the end of the day, our goal is simple. Women deserve honest conversations and real options, not care driven by fear.
Host: And what do you hope this change will mean moving forward, in particular at UK HealthCare?
Erica Marnatti, APRN, MSCP: What I hope that the removal of the black box warning on hormone therapy will mean for the University of Kentucky is that more providers will feel confident considering hormone therapy for women who could benefit. I hope it encourages more clinicians to seek out menopause-specific training and feel comfortable prescribing hormone safely.
Most importantly, I want fewer women to be dismissed, to stop hearing there's nothing that we can do. Providers should be able to look at the evidence clearly without decades of fear influencing their care, and give women the relief and long-term health support that they deserve. For large academic centers like UK, it's also a clear signal that investing in menopause education and training is essential.
Host: And in closing, Erica, is there anything else you'd like to add that you'd like women to know?
Erica Marnatti, APRN, MSCP: I would just like women to know that there are really good hormone therapy options out there that can be safe. I would say, you know, there's some women that cannot have hormone therapy for various reasons, but a lot of women can, and it can make a big difference in the quality of life that they experience every day.
Host: That's very encouraging, I'm sure, to a lot of people listening and watching. So, thank you so much for sharing your expertise. We really appreciate it.
Erica Marnatti, APRN, MSCP: You are so welcome. Thank you.
Host: Again, that's Erica Marnatti. To find out more, please visit ukhealthcare.uky.edu. Thank you for listening to UK HealthCast, a podcast from UK HealthCare.