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The 'Pause
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The 'Pause
The FDA Black Box Warning: Why Vaginal Estrogen Deserves Freedom
The FDA is considering removing the black box warning from low-dose vaginal estrogen products following a unanimous opinion from an expert advisory panel that risks have been overstated for years.
• Vaginal estrogen is a local, low-dose treatment that stays in the vagina with minimal systemic absorption
• The black box warning came from the 2002 Women's Health Initiative study that incorrectly applied systemic hormone risks to all estrogen products
• 72% of sepsis cases in older women could potentially be prevented with vaginal estrogen use
• Vaginal estrogen helps restore tissue elasticity, prevent UTIs, and protect the urethra
• Even women on systemic hormone therapy may need vaginal estrogen as the "vagina is her own little desert island"
• Application tip: use your finger to swirl the cream around rather than just using the applicator to prevent leakage
• Treatment regimen is typically twice weekly (like "Monday and Thursday vagina spa nights")
• Results may take up to three months to be fully noticeable
• Removing the warning could help more women access this beneficial treatment
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Welcome to the Pause, the menopause podcast, with unfiltered conversations about the symptoms you hate, the changes you didn't see coming and the hilarious moments midlife can bring. I'm your host, Val Lego, and I've been a dedicated health reporter for 25 years and I wanted to normalize something that every woman goes through menopause. That every woman goes through menopause. So recently the FDA announced they are considering removing the black box warning from low dose vaginal estrogen products. Now this is following a unanimous opinion from an expert advisory panel. Their reason the risks have been overstated for years and the evidence just simply doesn't support keeping this warning for local vaginal estrogen. So welcome back to the Pause. I'm a health journalist, menopause truth teller and fellow hormone rollercoaster rider. I want to talk about why removing this FDA warning is a big finger-crossed moment for us girls, because it gets us just one little pinky toe step closer when it comes to being equal to men and midlife hormonal health. Right now, the warning discourages some health care providers from prescribing vaginal estrogen, even though it can be beneficial for menopause symptoms like vaginal dryness and urinary tract infections. Urinary tract infections Raise your hand right now if you're wondering why you just got rid of one, and two weeks later it burns when you pee again.
Val :I know there's a lot of you out there. It's because your hoo-ha is screaming for estrogen, but the FDA is standing in the way until now. Maybe I don't know. We have to see. I mean, we're really hoping that that's about to change Because of that warning label gets removed, then millions of women will be able to say oh, in so many ways, all right. So to help us unpack what this means, I am joined by someone I deeply trust in the menopause space my co-host, nisha McKenzie. Nisha is a nationally certified menopause provider, a physician's assistant and a sexual health counselor who has dedicated her career to helping women feel informed, empowered and confident in their health decisions. So she's here to give us the real-life impact of this potential change, so you can make decisions for your body based on facts, not fear. I know you are excited to think about the potential removal of this label.
Nisha:Yes, it's been a long time coming. We've. You know, many of my amazing colleagues and friends have been to the FDA two other times in the past five to eight years, petitioning and begging and pleading and showing them all the data. This needs to be removed. That label on estrogen, the vaginal estrogen, is killing women and it needs to be removed.
Val :Yeah, I'm so excited about. Once again, we have to save the potential for this. So for women who might be out there wondering, you know, do I need vaginal estrogen? I'm, you know, maybe they're already on HRT let's talk about what vaginal estrogen is and how it's used.
Nisha:So vaginal estrogen is a low dose. We call it sometimes topical or local or low dose estrogen, usually used in some form of a cream or a tablet or a suppository. There is one oral product that can be used that targets the vaginal estrogen receptors. I would say, at least in my practice, that's not used super commonly but it's available. So typically when you put it in the vagina it stays in the vagina and so we can use vaginal estrogen in anybody 99.9% of the women out there.
Val :if you've got a vagina you can use vaginal estrogen, and you're talking about even women who've had breast cancer.
Nisha:Yes, I mean I could go into the details of the data, but we do have data? On this group as well.
Val :And most people. When they think about using vaginal estrogen, maybe they're thinking like you know dryness, pain during sex but let's talk about those UTIs. That was always surprising to me when I first started learning about this how important estrogen is when it comes to eliminating the number of UTIs. And when you think about the I don't want to call them nursing homes, but you know, when you you know homes that provide for the aging. There's a lot of older women who I know. My mother had dementia and she started getting you know UTIs like crazy and they always say you know that is a symptom that she might die from because of infection, and so I think that's an important fact to really bring home with that vaginal estrogen.
Nisha:And I think it's probably hit most of us right, we've all. My grandmother lived with us for four years before she passed and she, every time she would get a UTI, I would know because she would revert back to her native language. So I stopped being able to understand her. She'd speak some dialect of Indonesian or even of Dutch, and she just would lose her English. I'm like, oh boy, we got to collect her urine and this was before I knew much about vaginal estrogen or I would have had her on it. But these women, when we get older and we get a UTI, sometimes it presents differently. Like I said, like my grandma, her language changed and so we don't always know and by the time we find it then it can have spread through their bloodstream and that's something called sepsis and that's what can kill women. And there is data to show. There was a recent study that came out that said 72% of the cases of sepsis we could prevent if we just had these people on vaginal estrogen.
Val :That is an amazing statistic.
Nisha:It's like most.
Val :Yeah.
Nisha:Basically, you can just say most why aren't we doing this?
Val :Almost all women, yeah, yeah. Now so the vaginal estrogen. When you're using it for those purposes, is it thickening the skin?
Nisha:Yeah, it's making that tissue a little bit more elastic and oxygenated and robust and lubricated. And then the tissue that there's rugae or folds in the vagina, so there's supposed to be wrinkles. That's the one place as we get older.
Nisha:You want to have your wrinkles, we want to have wrinkles and we lose them there and we gain them up here on our faces. But so universe is a mean old trick. But those wrinkles or those folds in the tissue are what kind of cover and protect the urethra? They also on the belly button side of your vagina. They also make that tissue between the vagina and the bladder nice and thick and robust. And so if that tissue lacks estrogen it gets, I'll say, like flatter because it doesn't have those folds in it, and then it gets narrower, thinner, and so then the bladder can kind of gravity can kind of help it fall through a little bit, and that's what we call prolapse, right when the bladder kind of starts to come into the vaginal canal a little bit, because you're not, you don't have estrogen there Oftentimes. That's one of the reasons that that can happen, and then those folds don't cover the urethral opening, so then the urethra is just exposed.
Val :Oh gosh.
Nisha:And then we get more frequency, urgency, peeing at night, leaking and urinary tract infections. There's more exposure to the elements and all the bacteria that are down there but are not supposed to be in the urethra. So, yeah, it's really helpful to take that vaginal estrogen and put it in there. And vaginal estrogen is so cheap. You can get a tube of it from Mark Cuban's Cost Plus Drugs. If your insurance doesn't cover it or if your pharmacy charges a lot. It's $13. It'll last you a few months, Depends on how often you forget it Maybe three or four or five months. You need a prescription for it, though. You need a prescription In the United States. You need a prescription for it. There are some countries where it's over the counter, but here, you know, we tell people that it causes cancer and strokes and dementia.
Nisha:The black box warning yeah yeah, that black box warning is what stops people from using it. So if I you think about your typical medical system, they have I don't even know what the average is right now seven and a half to 12 minutes per patient. So the amount of time that they have to go through all of your problems, give you their prescriptions and then sit and explain black box warnings to you, it's not going to happen. So they're going to say, yes. Maybe they'll say yes, you need some vaginal estrogen. Here's this, here's how you use it.
Nisha:You get out the door, you go home, you pick that up and you put it on the table and you and your spouse look at it, or your partner and you go oh my God, this has probable dementia, breast cancer, heart attack, strokes. It's not worth it. We don't need to have sex, babe, like I want you alive. And then that practitioner doesn't see that person again for another year, until their next annual. And so in a year, all the changes that have happened in that vaginal canal, as well as the relationship. Now, if she did get UTIs as the gynecology provider, she might have gone to her primary care provider. They just treat the UTIs, she leaves, that's it. And then I don't see her for a year, right, and she hasn't had that benefit of the badgel estrogen for a whole year Do we even know where this warning came from.
Nisha:From men. That's usually the answer. It came from the WHI, oh my gosh it was in 2002. When that released, the FDA said, oh, hormones cause cancer. And they put a black box warning on all estrogen products, regardless of dose, like route of delivery, what type, whether it was a bioidentical, whether it was synthetic. That it was a blanket statement and they didn't have data to back it up, but they just everybody got scared. So they said black box warning.
Nisha:And it's called black box because there's actually a black box on it around it, so it can stand out and it's the highest level of warning of risk that is issued by, issued or mandated by the FDA.
Val :Now, if you're on hormone replacement therapy although I've been seeing it called HT now, not the replacement, it's hormone therapy. I don't know why we have to get rid of the R, but you know.
Nisha:Semantics. We're a little picky about words. We were just talking about this, you and I, I'm very picky about words because we're a little picky about words. We were just talking about this, you and I, I'm very picky about words because we're not replacing what you had when you were 20, which, if we were thinking about that, that would potentially offer different risks, right? So we want to be really clear about what we're doing. We're not replacing that. We're not. We're not giving you those high levels. We're giving you just enough to where the data shows us it can subdue some of our symptoms, of the the vasomotor symptoms, the hot flashes, the night sweats, the things that we feel and prevent chronic disease in the future. Okay, from this day forward, ht, ht, mht, menopausal hormone therapy Some people will use ET for estrogen therapy, so there's lots of ways to do it. But yeah, we're trying to drop the replacement. It's not wrong to say it, okay.
Val :But if you're on HT, vaginal estrogen still a good idea? Yeah, because systemically.
Nisha:For some reason it's like the vagina is her own little desert island All the way in her own zip code. You need a passport to get there. So when I take something systemically, a small portion, maybe a third of the women that will help their vaginal.
Val :And so when you're talking about systemically, you're like whether or not you're taking your hormone therapy on a patch or through a pill.
Nisha:Oral or injection or trochee yeah, anything you use for your hot flashes that is going through your whole body and your blood system. It sometimes helps the vaginal mucosa, but not often. Most people do need some vaginal estrogen, so I love the fact that we gave the history of it.
Val :But it's also pretty telling that all these years later, the panel unanimously is like hey, we need to take this off. And why Is it? Because we've been so vocal about it and talking about it and in their face about it. I don't know.
Nisha:I mean the panel and some of those people that were on the panel were the people that went the last two times as well. The FDA is under new leadership right now. They're showing an interest in what is happening in women's health and so I mean I'm glad that they had this panel. There's a little bit of kickback, right. People are saying, well, this was just kind of a media stunt and are they actually going to change anything? And also, it was supposed to be addressing that low-hanging fruit, the vaginal estrogen, because we have. I mean it is black and white spelled out. We know the risks, we know the benefits and you know, in the panel there was other talks about systemic therapy, changing the black box warning on systemic estrogen therapy, on testosterone therapy, and some people were kind of arguing like we should have stuck with the easy pass. But I get it Like you got the ear of the FDA. All of this does have to change because women are dying either way, because it's not changing.
Val :But yeah, there's a lot of chatter back and forth in the menopause world and there's not really a timeline as to when that could get removed.
Nisha:I mean, my hope is, if nothing else people have heard about this by now, even though we're at the FDA mercy that maybe if someone who doesn't have time as a practitioner, as a prescription writer, to go through here's what the black box warning I mean, my actual spiel to patients is all right, listen, I know you met me 20 minutes ago and it's a big ask to say trust me over the FDA. But I'm going to ask you to trust me over the FDA because they got this one wrong. Right, and it usually brings a little chuckle, but it's like really pathetic that you got to say that right, but if someone doesn't actually have that conversation, my hope is now more people have at least heard, and when they get home and they fill their prescription and they see that boxed warning on there and then they go oh, that's that thing I heard about, I don't have to worry about it.
Val :Yeah.
Nisha:Because that is just wrong. A single piece of data out there in the universe that shows any of the risks that are suggested or that are stated on the Black Box warning on vaginal estrogen?
Val :Do we know next steps of the FDA, yet no, okay, so they could have. Just that's why they're saying maybe it's a media stunt. They came out, they said their piece and then they went away.
Nisha:Yeah, or I mean I think that there's pretty good hope that this will change. Yeah, or I mean I think that there's pretty good hope that this will change. Some people are saying, you know, is this the are they covering? Are they using this to say, see, we care about women's health and then take away something else? And that is a distinct possibility. But you know, I don't know, one brick at a time, one step at a time. If we can at least get the vaginal estrogen covered, we can have people living longer, stronger, healthier lives. We don't want to live longer sicker, no Right, but we can live longer healthier.
Val :Speaking of healthier. So when you start using the vaginal estrogen, like, how soon is it like immediate results? Like you put it in there and it's like drinking water, yeah.
Nisha:No, unfortunately. I mean it can take a good three months, depends on how severe your symptoms are prior. But I'll tell people if you're not having problems with it. Give it 12 weeks, give it three months, before you call and say I'm not sure this is doing it. It's just a matter of finding something that works for you. A couple of the tricks.
Val :You want some tricks, of course, some how-tos, yeah, some how-tos.
Nisha:If you're going to use the cream. The cream comes in a tube and it comes with one inserter. And for all you listening that have tried this inserter, you all are going yeah, that damn inserter, I know exactly what like. Oh, people are constantly. You get one for the whole three, four or five months, right, so you have to sanitize it. In between People are trying to run it through their dishwasher.
Val :Who's honestly really doing that.
Nisha:Well, or they're taking. What most people tell me is like oh, I'm taking a Q-tip to the edges and trying to get it all clean, so I'll say, listen you. And then you sploosh it up on in there.
Val :It's kind of like sploosh back out Right Almost, a little bit like when you, when you have like yeast infections, those over-the-counter yeast preparations I mean it's goopy right.
Nisha:Even I've had a patient tell me a while ago. She goes, I cannot stand it. I put it up in there. It doesn't leak out the next day, it leaks out at night and I'm laying in bed and then I just feel it kind of like oozing out. It goes up, my butt crack and it's all right.
Val :It just wakes you right up and you're like what's's happening?
Nisha:She's like ew. So if you can imagine you put a glop of lotion on your forearm and then you flip your forearm over, it's probably going to fall off. If you put that glop of lotion on your forearm and you just take your fingers and you just swipe up your forearm once, back down once maybe, and then flip your arm over, it's not going to fall off. So if you take your finger, as long as you don't mind putting your finger, put your finger up in there, give it one or two swirls around. Listen, if you want to spend 20 minutes in there, more power to you.
Nisha:If you want to make it part of your daily or weekly routine if this is part of your stress management, you do, you boo, like, get it, but you don't have to. One or two swipes around. When your finger comes out, it's covered in the cream, it's a thick cream. Wipe that at the opening. That's where your urethra is, that's where your clitoris is, your labia minora Like, rub it all around on there, then it's not going to sploosh out. Some people will even use it in the morning then, because they can. Usually people use it at night, so they're laying down so it doesn't sploosh but it stays where it's supposed to. And then you get a little bit at the opening, where you need it as well, and you use this.
Val :Then Two nights a week Two nights a week, forever.
Nisha:You can pry mine from my cold dead hands. That's what I mean. Like yes, forever, because our ovaries aren't coming back. And so I just tell people like you, tell your partner Monday, thursday, these are either my vagina spa nights you're not invited Right or you have sex first, put this in after. And if you do have sex after they've done partner studies on most of these products they're not going to harm your partner. Even if your partner is a man, he's not going to grow man boobs. It's not going to micronize his penis. I have been asked that. It is just going to be, at worst, messy and wasteful. So if we're going to have sex afterward, if I'm laying down, babe, and I'm on my side of the bed and it's Monday or Thursday night, you know that's in there. So if we're doing this, we're doing it on your side of the bed and you got clean up duty.
Val :I like it. Do you think? This is going to be probably one of my last questions, but do you think that this black box warning, if it gets removed, would pave the way for vaginal estrogen to be over the counter?
Nisha:I mean, that would be amazing.
Val :I feel skeptical Okay.
Nisha:As you should. But I mean, it took until just what last year that we got an over-the-counter birth control pill Right. It's been talked about for a long time. So medicine moves slowly. I don't know that that'll happen in our lifetimes, but that would be lovely. Yeah, let's shoot for that, all right. Vaginal estrogen OTC baby.
Val :I like it. I like it. Oh, any last thoughts on this topic before we say goodbye.
Nisha:I think just the main thing is to just remember that vaginal estrogen is different than systemic estrogen. If we remove that box warning off vaginal estrogen if the FDA does, that doesn't mean they're going to remove it off systemic, like your patch and your pill. I think the systemic estrogen warning needs to change. May not need to be removed but it does need to change. But the one off vaginal estrogen needs to be removed. And remember, if you're scared of estrogen, there's so much nuance to it. So talk to somebody who understands what hormones do and don't do in your body and what types, and see if most likely vaginal estrogen is going to be appropriate for you.
Nisha:Yeah.
Val :And you know, nisha, I really feel like it's conversations like this that can help women feel prepared, empowered, like to make choices for their body. They are going to be able to make the choices for their body, instead of somebody saying this is what you can, and can't do Right.
Nisha:You've heard me say it a million times we took away choice. Whi, the Women's Health Initiative, created an environment so that the world could take away choice from women. So that the world could take away choice from women, we no longer immediately. We stopped training people and we stopped giving women the choice to say here's what the risks are, here's what the benefits are, what would you like to do?
Val :Hopefully we are starting to make that change and make it stick Not necessarily like vaginal estrogen.
Nisha:Yeah well, I mean just swizzle it around once or twice and maybe it'll stick.
Val :Hey, if this topic struck a chord with you, just swizzle it around once or twice and maybe it'll stick. Hey, if this topic struck a chord with you, I would love for this conversation to keep going inside our private face group, the Pause Diaries. This is a safe, supportive space where we talk openly about perimenopause, menopause and all the changes that come with it. So join us at the Facebook groups, the Pause Diaries. Remember menopause isn't the end of anything. It is the beginning of the rest of your life and we are going to talk about it. The Paws podcast is for informational purposes only and not intended as medical advice. Always talk to your health care provider about any questions or concerns. Views shared by guests are their own and don't replace personalized care from a qualified professional.
