Hormone Replacement Therapy for Menopause: What the FDA’s Black Box Removal Really Means for Women

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0:43So, order more pizza. The math demands it. Get the Venmo debit card. Venmo Stash bundle terms and exclusions apply. See terms at Venmo.me slash stash terms. Venmo checkout not available at all merchants. Venmo MasterCard is issued by the Bancor Bank NA. Is the FDA's new update on hormone therapy dangerous? This is what a lot of people are asking right now. And honestly, the confusion is understandable. The FDA just removed the black box warning from many menopausal hormone therapies. And anytime a major regulatory agency changes course, people worry it means something risky is slipping through the cracks or that this change might be something that isn't in our best interest.

1:25So we're going to be talking about this today, and I'm going to give you some protocols to help you start supporting your estrogen metabolism in this episode. But the real story is that the old warning labels were based on outdated data, and they were scaring the wrong women away from treatment. Today, we're going to break down what the science actually says about hormone therapy, who benefits most, who should avoid it, and why your formulation and timing matter more than the news headlines. So first, why did the FDA change the warning? So you'll hear people say that the FDA made hormones safe again, but that's not totally what happened.

2:08So let's talk about it. This shift in labeling is about accuracy. For years, the boxed warning was based on a study of women whose average age was about 63, and they were starting hormones often a decade or more after menopause, after there had already been the onset of cardiovascular disease. And now we understand that timing matters dramatically. So there is a critical window in which we want to start hormones, and that is within 10 years of menopause. That is your final period. So for those women who are still in perimenopause, that is, they haven't had 12 consecutive months without a period, or anyone within the first 10 years of menopause said, oh, that is 10 years from your last period, the risk-benefit profile of hormone therapy looks very different than starting women who are 10 plus years, maybe even 20 years post-menopausal.

3:11Cardiovascular risks, cognitive symptoms, metabolic changes, and hot flashes, those all respond more favorably when they're started earlier. And the FDA update reflects this modern data. It's not a loosening of safety. It's not just opening up the floodgates so that everyone and anyone takes hormones, it is reflecting on the Women's Health Initiative having done harm, not being the best data we can work off of. And as we've gotten updated data, we have now seen an update from the FDA, and that's the way science should work. Now, one clarification that rarely, if not ever, makes the headlines is vaginal estriol.

3:56Vaginal estriol, or E3, is universally accepted as safe because it doesn't meaningfully enter the bloodstream. So estriol is a form of estrogen. It's the weakest estrogen we have. And when you use it vaginally, it acts locally. And so that improves vaginal dryness, painful sex, urinary symptoms, recurrent UTI, recurrent BV, yeast infections, because it helps positively modulate the microbiome, support tissue integrity, and doing it all without raising systemic estrogen levels. So when we use the weak estriol vaginally, it doesn't lead to increased circulating estrogen in the body in a significant way.

4:43And this means even many women who can't use systemic hormones, like in some instances, breast cancer survivors are told to avoid systemic hormones, using vaginal estriol under medical guidance can be done safely. So vaginal estriol should have never had that black box warning. It was unfair. It was done dirty. And so this is one of the reasons the FDA lifted the black box warning on that particular form of estrogen. Now let's talk about breast cancer and what the data actually shows because this is the fear women bring up most and for good reason. So let's get into a bit of the nuance here. Estrogen itself is not the main driver of breast cancer risk.

5:29In fact, new research is pointing towards synthetic progestins. Those are the things you find in oral contraceptive pills, the combination pill, the IUD, the Depo shot, and sometimes these are being used in women who are post-menopausal. Honestly, oral micronized progesterone, Prometrium, body identical progesterone, all of the same thing. That's a much better route to go than using progestins. And so while estrogen has been vilified for a very long time of being the primary driver and cause of breast cancer, what we know from the Women's Health Initiative, one of the pieces of data that's actually useful to us is that estrogen-only therapy was associated with a lower risk of breast cancer.

6:16That doesn't mean you should use estrogen alone. Very good reason, if you have a uterus especially, to use estrogen with progesterone. However, I would also argue, on behalf of progesterone, that your brain also needs it. I will link to episodes all about that. However, it's important to understand that that data and subsequently more studies have shown us that we should be more cautious with progestins. that's not saying we shouldn't be cautious with estrogen but we haven't in medicine seen people being as cautious with progestins as they've been with estrogen and so in the women's health initiative estrogen alone lower risk of breast cancer combined therapy when you use synthetic progestins like medroxyprogesterone acetate that showed an increased risk of breast cancer so this nuance of what hormones we're using matters.

7:11And modern protocols, so the ones I had used for over 13 years that my colleagues that I respect in the menopausal field, those that have been prescribing for over 25 years, we're using body identical micronized progesterone. That has been shown to be very different and often has a neutral risk profile. We certainly need more studies on it. But again, if you're in the United States, you're looking for Prometrium, oral micronized progesterone is the generic that it will say, and you want to avoid progestins if breast cancer is the concern. Or honestly, if you want to sleep at night and have a great mood, don't go with progestins, go with progesterone.

7:57And unfortunately, many doctors and scientists get it wrong often and call progesterone progestin, progestin, progesterone. And this is why using the right formulation matters, not just the hormone category of progestogens. We want to be looking at, are we actually using progesterone or are you using progestin, which we know has a higher risk profile and not the same benefit as progesterone. Which brings me to another point in that not all hormones are created equal. So for years, everything from conjugated equine estrogens to transdermal estradiol patches to oral synthetic progestins. It was all lumped into the same conversation.

8:35And that is scientifically inaccurate. The truth is, like when we look at estrogen, for example, transdermal estradiol, so that's E2, applied to the skin has a lower clotting risk than oral estrogen. Oral estrogen is sometimes used for menopause therapy. Sometimes it is using the birth control pill, and that we know can raise clotting factors. Anytime we take estrogen orally, it can raise clotting factors. So when we're talking about estradiol, most prescribers are going to want to use topical, but we have to monitor because not everybody absorbs things the same. And then remember estriol, that's our E3, low potency, largely local in its action.

9:22That's also why women can use it on their face and not have that go systemic. Oral estrogens can also increase hepatic factors like thyroid binding globulin. So if you're someone with thyroid disease, you take a thyroid medication. If you start an oral estrogen, we need to test you and follow up about six weeks later to know if we have to increase your dose of thyroid medication. So often we're going to go with the patch because it's more stable levels. The pill can have more fluctuations because it depends on absorption, but also first path through the liver. And so there's considerations in the type of hormones we use and the delivery.

9:58And when women say hormones didn't work for me, it's usually because of the type of hormone or the route that's being used. So if you're someone who's ever been like, yeah, progesterone just doesn't work for me, I'm going to direct you to my episode that's all about progesterone side effects. and I talk about progesterone intolerance because sometimes it's progestin, sometimes it's the route that we use. Now let's talk about the benefits of modern hormone therapy. Here's what high quality studies consistently show when hormone therapy is used appropriately and is started at the right time. Remember, timing matters and then using it appropriately.

10:37The birth control pill is not an appropriate treatment method for those in menopause. We've got much better things to use, But when we do hormones right, we certainly see fewer hot flashes, fewer night sweats. We see better sleep quality improves. Anxiety can be reduced. Irritability can be reduced. And we also see sometimes women have a more positive outlook. So there is a well-recognized phenomenon as we go into perimenopause that this is a very vulnerable population when it comes to mental health issues and to cognitive fluctuations. So when we use hormone therapies, we also sometimes see improved cognitive function, improved working memory, improved word recalls so you're not like forgetting what you were saying mid-sentence or being like, what was that word?

11:24What was that thing that I was talking about? The other positive changes we see is better insulin sensitivity and metabolic health. And that is because when estrogen declines, it changes our fat distribution so that we have visceral adiposity increase the fat that packs around our organs, that's metabolically active. That can lead to insulin resistance. And so using hormones may help mitigate that. We certainly know that estrogen, when we give it appropriately, can result in less bone loss, less fracture risk, and overall better health for our joints, our muscles, our bones all together. And you know, as I was talking about insulin, I should have also brought up, there's a possibility of cardiovascular protection when we start it early, not when we start it late.

12:14Once you've laid down plaques, once you have adverse changes, we're not going to reverse that with hormones, but we may be able to protect the blood vessels when we're using estrogen therapy. Now, something that shouldn't be overlooked is pelvic floor health, sexual comfort, sexual desire. We know that estrogen can help improve these things, sometimes testosterone as well. Estrogen is also supporting our skin, our collagen, our hair growth. And honestly, when you talk to women and you look at the cases of women who have started hormone therapy, they report a better quality of life overall. You know, we understand that the genital urinary syndrome of menopause, which is where you have pain and atrophy and you can have repeat infections in the urinary tract, in the genital region, we understand that that is associated with a significant reduction in quality of life.

13:11And so when you consider that something as safe as estriol could help people get the quality of life back, their self-image, their self-esteem rises, and it's not going to go systemic and cause harm, it makes sense why the FDA would want to remove the black box warning because it was never appropriate to have on that particular medication to begin with. One thing I hear from women all the time is that they're struggling with symptoms like hot flashes, sleep disruptions, and brain fog, but aren't sure where to turn to for help. Menopause is inevitable, but suffering through it isn't. That's why I want to tell you about Alloy.

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14:41Brighton. So I want you to keep in mind that all of these benefits are well-documented in the research, and they are also linked to the type of therapy, the woman's age, the timing from menopause, the symptoms that she has, her risk profile. So these things are not happening as like, oh yeah, we just give it to everyone. It's safe for everyone, but it's also not something where we need to necessarily be denying everyone some of these therapy options. So is hormone therapy safe? Honestly, the real question isn't is hormone therapy safe. The real question is, does your hormone profile, age, your personal and family history, so medical history, does all of that match the women who benefit the most from hormone therapy?

15:32because for the right woman, especially one in her 40s or her 50s, who's dealing with anxiety, depression, insomnia, night sweats, mood swings, vaginal dryness, any of the symptoms of rapid estrogen drop, hormone therapy is one of the most effective tools in all of medicine. But for the wrong woman, such as someone with a history of estrogen receptor positive cancer or certain clotting disorders. It may not be appropriate or certain routes might not be appropriate. And this is where individualized evidence-based care matters and you need to have a conversation with your doctor. Someone who has had breast cancer, most oncologists are fine with vaginal estriol, so the vaginal E3.

16:18However, they're not going to be okay with someone taking oral contraceptive pills or using oral estrogen. And so there's a lot of nuance here and the cookie cutter approach of like, we just do this for everyone. It doesn't work. So let's talk now about how to support your estrogen metabolism if you're using hormone therapy. Because I want to give you something practical that you can start right away and simple enough that you will want to follow through on it. So if you are on hormone therapy, this is what I do with my patients. So step one is phase one liver detox. That's your liver's first pass of estrogen, the estrogen circulating in your body.

16:59To support that, we can aim for one to two cups of cooked cruciferous vegetables a day. Broccoli, kale, cauliflower, brussel sprouts. These are going to help push estrogen into the more beneficial metabolite pathway, which is the 2-hydroxy pathway. And these are delivering DIM. DIM as a supplement can help too, but only if you tend to run high on your estrogen or you're taking estrogen therapy. Not if you're someone who is not using hormone therapy, you're perimenopause, menopause, because DIM can detox estrogen too fast. So DIM is great in our cyclical years. DIM, the usage requires a little more nuance as we get into perimenopause and menopause.

17:41But there was a recent study showing women on hormone therapy who supplement with DIMM do have more favorable estrogen metabolites. So the 4-hydroxy and the 16-hydroxy pathways, those cause tissue proliferation. They're associated with the cancer growth. That's not to say that 2 is completely protective, but we want to favor the 2-hydroxy pathway. Now, step 2 is phase 2 detox. That's where your body is going to neutralize estrogen metabolites so they can be safely excreted via the bowels and the urine. methylated B vitamins, magnesium, choline-rich foods like eggs, and getting enough protein every day make a huge difference here.

18:25DrBrighton.com slash plan is a whole meal plan to help you get the nutrients you need to optimize your hormone levels and make sure you're getting enough fiber and protein to support these estrogen pathways. It's totally free. It's also going to give you information on how to sleep better, how to move better, how to take care of your body through the perimenopause and menopausal years. Again, that is at drbrighton.com slash plan. All right, step three, we need to support your gut health. You got to eat fiber. You got to eat fiber to actually get your estrogen out of your body, the estrogen you no longer need.

19:04We want to aim for about 25 to 35 grams a day, and we want to make sure we're staying hydrated. That's going to help with our bowel movements. That's also going to help moving estrogen out through the urine. We want to aim to have at least one bowel movement a day. This is one of the ways that we move out metabolic waste, including the estrogen we no longer need. Now, the fourth step, once you've mastered that, is we want to start lowering inflammation. Omega-3 fatty acids in the diet or supplementing with something like Omega Plus, strength training a few days a week, and decent sleep each night.

19:40that's going to make your estrogen therapy work a lot better. You're going to feel a lot better. And then remember I said we need to check thyroid health if you're using an oral estrogen. We also want to check things like ferritin, liver enzymes, cholesterol, waist to hip ratio, hormone levels. That way you are not just troubleshooting this blind and going into these protocols with your doctor blind. We want to track these things. So this is the foundational support that can help women feel better on estrogen therapy, have better outcomes, avoid unnecessary dose increases. So I would really encourage you to adopt some of these things into your lifestyle.

20:22If you can take a minute and leave me a review, it helps this podcast get out to everyone who needs it. I really appreciate your support. Leave me a comment. Let me know what was helpful about this episode and what you would like to hear more about. So in conclusion here, the FDA's update, it's not everything the headlines are making it out to be. And it's not just opening up the floodgates so that everybody just starts taking hormones. It is updating the information based on the science we have now and looking at the outdated information that has influenced women's hormonal health for the last 20 years.

21:01This is important. As we get new science, we adapt and we update. And honestly, the FDA is usually really far behind. This was still a little bit behind, but we are happy to see updates being made. Again, this doesn't mean that like everybody needs to go jump on hormones. What I would say is everyone needs to have a conversation with their doctor. Yes, hormone therapy is safe when done right, when started at the right time, and for the right person. These are the things we have to consider. We can't make a blanket statement and say hormone therapy is safe for everyone, vaginal estriol being the exception there, and at the same time we shouldn't be saying it's not safe for anyone based on outdated data done on the wrong population prescribed in a way in which we don't even do it anymore.

22:00So thank you so much for being here with me today. I appreciate your trust in me. I appreciate getting to have this time with you once a week to have these conversations, and I will see you next time. This episode is brought to you by Google Chrome. You think you know a browser, but Gemini and Chrome, that's new. It can help you with practically anything on the web, like restoring a vintage motorcycle from a 50-page restoration or finally break down that long article you've had open for weeks. Gemini and Chrome is here for it. Ready to make anything online make sense? There's no place like Chrome.

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