Menopause hormone therapy treatments sheds its warning label. Here's what it means.

NINA MOINI: Well, the Food and Drug Administration has removed their black box warning from hormone-based drugs used to treat menopause symptoms. This black box warning has appeared on hormone-therapy treatments for nearly two decades, after a landmark study found the therapy could increase risks of cancer. But now the FDA is changing course. Here to help us understand how this decision will impact patients in Minnesota, is Diane Feller, a certified nurse, midwife, and menopause practitioner at HealthPartners. Thanks so much for being with us this afternoon, Diane.

DIANE FELLER: You're welcome. Thanks for having me.

NINA MOINI: I'd love if you could start to just tell folks what hormone therapy is and how it, in particular, is used to help people experiencing menopause.

DIANE FELLER: Yeah. Well, to start out with, the hormones aren't for everybody, but they can be very helpful for women going through menopause transition, which starts in the 40s goes through the 60s. So it helps with symptoms. But it also can be beneficial for bone health and just feeling good.

And so hormones are very appropriate and important for most women. There are women that you do need to counsel and discuss more clearly about the effects of the hormone therapy. And depending on their medical history and their history, it all comes into that decision.

So I think what we were glad to hear that the FDA's decision to remove that boxed warning on low-dose vaginal estrogen therapies used to treat genital genitourinary symptoms was good. We've been hoping that would come out for years. But it may have been misleading a little bit because systemic estrogen still comes with some potential risk for certain individuals. Should I go on?

NINA MOINI: Yeah, I mean, and what are the risks then for-- who would not be a good candidate?

DIANE FELLER: So somebody with a history of breast cancer, a strong family history of breast cancer, somebody who has had a blood clot, heart attack just would not be appropriate for the hormones. A lot of counseling goes into that. There are non-hormone therapies that are out there now. So that's encouraging. That's going to be helpful.

NINA MOINI: Yeah, I guess I wonder, with the black box warnings, it sounds like an intense warning that would be on there. And I just wonder, throughout your career, have you seen these come on and off of things? How serious of a warning can it be? I realize science changes over time and discoveries are being made all the time. But what are your reactions, I guess, to that, the removal of that?

DIANE FELLER: So the boxed warning that we were hoping for and that did come out, but it's kind of blanketed over all the hormone therapies, but was mainly for the vaginal estrogen. For years, that black box warning has said it increases the woman's chance of breast cancer and blood clots. And vaginal estrogen just acts locally on those tissues. So that really isn't appropriate to put on that hormone. And like I said, for certain women that might apply for the other hormones. So that are not vaginal estrogen.

NINA MOINI: Yeah and you mentioned just the decision making that goes into things like this and the consultation and the conversation. Overall, do you think that this Warning label removal will lead to more people receiving these treatments? I wonder if it means anything like insurance wise or cost wise to folks, if you hear much about that.

DIANE FELLER: I think it's going to be out there even more than it is right now. Hormone therapy has been in the media a lot the last one to two years. So I think it's just going to make people be more aware. But I think they might have the misunderstanding that any hormone is going to be just fine to take, and that needs to be discussed with the patient as far as all their risks, which can be greater if it's initiated in an older woman, the time to start, especially estrogen systemically would be more around that final period when they're say, around the age of 50 is the average age. You don't want to wait and start estrogen later.

So I think it's a good thing. It's going to be bring awareness even more to the importance of hormone therapy. But it also is going to be a misunderstanding for people that this is safe across the board, and needs to be more of a discussion on that, as far as the FDA and the advisory committee meetings that should be held when they come up with these recommendations. But we were glad to see that it was removed from the vaginal estrogen that has been keeping women from using it for many years.

Some women fear they're going to get breast cancer from it. And they can have very severe genitourinary symptoms, either bladder health, vaginal health. So it's very beneficial for that. And that is good that that black box is off that. But it's not going to blanket all of them.

NINA MOINI: Yeah, it's still important to be having those conversations with your provider and asking those questions. I do wonder, Diane, as somebody who is a menopause practitioner, how do you feel about just how much more people are generally talking about menopause? I feel like in just the last year, almost-- not out of nowhere, probably. But it feels like out of nowhere there are so many conversations happening. How does that feel for you?

DIANE FELLER: It's good and bad. I mean, there's some really good conversations that come out of it and good information. But I think this pendulum has swung really far, whereas 13 years ago when I started just doing menopause therapy, people were scared of going on hormones. And now there is a barrage of patients. We've had to increase the number of providers that we have at Park Nicollet doing menopause care for that very reason. There's such a demand, which is a good thing.

But then there's also misinformation out there. So like anything on the internet, you can go down the rabbit hole and get misinformation. So there's good and bad things about this new awareness of it. So I think it's helpful for women because yeah--

NINA MOINI: Yeah, and I think, too, people might not even honestly that there are specific providers and people helping with menopause. How can patients advocate for themselves when they are at the doctor's office, asking about hormones or anything like that? I mean, what do you recommend?

DIANE FELLER: Yeah, and that's a good question. I think just asking for information, and if that provider cannot give you the information, if they can refer you to somebody that could, the Menopause Society, who I'm credentialed by, and the other providers here that are doing menopause care, on their website, you can go on their website and you can look at your, I believe it's a zip code. It might be the city or whatever. Find a menopause practitioner in that area. So that's quite helpful.

Because I do have a lot of patients that come and they've been not listened to when they say they have not been listened to, or they just haven't gotten the information that they wanted. And some have waited many years so they're almost past that point of starting on estrogen systemically.

NINA MOINI: Yeah, people are in a lot of different situations. It's good to keep having the conversation and bringing it out into the light. Why not?

DIANE FELLER: Yes, yes.

NINA MOINI: All right, Diane.

DIANE FELLER: Always just to how it's all come about.

NINA MOINI: Thank you very much. Appreciate your time. Bye-bye.

DIANE FELLER: Thank you. Have a great day. Bye-bye.

NINA MOINI: Bye that was Diane Feller, a certified nurse, midwife, and menopause practitioner at HealthPartners.