Exciting News! FDA removes Black Box Warning
Back in 2003, after the Women’s Health Initiative (WHI) study was published, the FDA used data collected from that study to place a black box warning on all estrogen products sold in the US. The reasoning for this was that the WHI claimed that hormone therapy increased the risk of multiple diagnoses such as heart disease, blood clots, and breast cancer. But over the last 22 years, women’s health experts continued to extrapolate the data and showed that the original conclusions were misinterpreted. The results were catastrophic. A generation and a half of women went through the menopause transition being told to avoid hormones at all costs and providers were taught to not consider these medications in midlife care. This resulted in these women having to suffer the effects of hot flashes, night sweats, mood changes, bone loss, and as it turns out, an INCREASED risk of cardiovascular disease due to the lack of estrogen.
Fortunately for those of us in the current midlife landscape, a small but growing group of experts were vocal and brought receipts! Study after study, showing both the fallacy of the WHI’s conclusions and the data that supported the usage of hormones for health and longevity, were presented to the FDA. On Monday, they officially removed the black box warning.
Why does this matter? The black box warning inhibited patient-centered care. Providers generally want to mitigate adverse reactions to medication and they certainly do not want to increase anyone’s chances of a cancer. It shaped how future medical providers were taught. It limited access to medication plans on insurance. It took away an option from women who were suffering. And that is why this is a big deal!
This does not mean that all women are eligible for estrogen therapy but it allows for expansion and research to determine what is safe and for whom it is safe. It again re-emphasizes the reason that it is so important for women to seek out care in someone who has furthered their studies and trained on the usage of hormone therapies. Many providers have used the black box warning as their scapegoat to not prescribe these life-saving medications to anyone.
If you have been told, “No, our office doesn’t prescribe that” or “You can only take those if you have no family history of cancer” or even, “You are not old enough to be experiencing symptoms,” you deserve better. At Sapphire Wellness, we will review YOUR personal medical history, YOUR FAMILY’S medical history and discuss what is available and what is not an option. We will tailor a plan that works for you and we will walk with you if we need to change or alter anything to achieve better results. This significant change in status of these meds shows that we have to evolve in medicine and also that you don’t have to just suffer through this time of your life!
WHO you see is what you get!
In October, the Menopause Society met for their annual conference and many topics of discussion were addressed. One that may intrigue women, especially women who are concerned they are going through perimenopause or menopause, was the thought that what type of provider you see dictates whether you will be prescribed hormone therapy or not. As if it isn’t already hard enough to be prescribed hormones (only 3.8% of women, ages 45-59 have used hormone therapy), if you are only seeing certain specialties of practice, it may limit you even more from being prescribed these potentially life-changing medications.
If you are not already aware, menopausal health education in the setting of medical school, PA school, and NP school is minimal at best. Researchers also believe there isn’t a real standardized curriculum that provides guidelines for new providers entering the field and there certainly was minimum attention given to teaching this topic to those providers already out in the workforce.
So where are you most likely to find a provider who will be willing to consider treatment? Of all provider specialties, a GYN is your best bet. Although even within that group, midwives and NPs were more likely to prescribe than physicians. SSRIs seemed to be the medications of choice for physician associates in that field. This makes sense when you work in this field and hear every day about how women are dismissed or told they don’t need to take anything for their perimenopause/menopause symptoms. While most women see a primary care provider almost every year, they may not be well-trained or even feel comfortable prescribing menopausal treatments. Clearly, something needs to change!
Studies show that LESS THAN 10% of residents in Internal Medicine, Family Medicine, and OB/GYN programs feel prepared to manage menopause after graduation. That means a whopping 90% of those going into the field of medicine are underprepared. This is an educational lapse and needs to be amended. So what is a woman to do? First, you need to be prepared that your primary care, ob-gyn, or other specialist is NOT well-trained in this area. It is always good to ask and certainly a great conversation to have if you have good report with that provider. You may also seek out those of us who HAVE gone beyond our original training and are educating ourselves with evidence-based studies and teachings that we didn’t receive prior to our degree. If a provider has MSCP after their name that means they are a Menopause Society Certified Provider. They have studied and opted to take additional testing that gives them this designation. They are most-likely more up-to-date on the current practices of menopausal care and how it impacts their female patients. They are worth seeking out if you are really struggling with symptoms.
While perimenopause and menopause treatment plans gain traction and are showing a generation of women that they do not have to suffer the significant side effects that this decade of life may throw at them, the call to provide a more comprehensive educational component in all provider training programs is evident. As the movement and the knowledge that the general population has toward symptoms continues to reach more women, we owe it to our current and future providers to educate them on the advancements that could make a world of difference in their patients lives!**
**Statistics from The Menopause Society’s Presentation at its annual conference held October 21-25, 2025, titled, “Likelihood of Being Prescribed Hormone Therapy May Depend on the Type of Provider Seen”
Timing of HRT is VITALLY Important
The Menopause Society met last week and one of the most important take-aways involved timing of hormone therapy. The Society presented on October 21st, 2025 that a new large-scale analysis shows promising long-term benefits by starting hormone therapy in the perimenopausal years instead of waiting for full cessation of menses and official menopause.
This has been the assumption in the menopause world for sometime and makes a lot of sense if we look at the physiological effects that drops in estrogen, progesterone, and testosterone have. Let’s use an example of an athlete in a marathon. We wouldn’t advise that person to hydrate before the race started, then skip every water station until the twenty-first mile. That would really mean that athlete would have to make up the fluids lost and then hydrate enough to finish the race, it would be really hard to catch up. The same may be true for these hormones. If we can maintain some semblance of a woman’s normal levels, she may transition through the timeframe and also provide significant preventative effects to her bones, brain and heart.
We know that the menopause transition can have effects like increased risks of cardiovascular disease, dementia, and osteoporosis. Prevention really means timing is essential because we know that once something is lost or poorly controlled, it becomes exponentially harder to improve it (think bad cholesterol without using statins!). How life-changing could this new thought be if women starting estrogen, progesterone, testosterone, or all three when it really made the greatest impact? We could see less debilitating osteoporotic fractures, cardiovascular disease could potentially reduce, and women may not suffer with dementia at rates now seen! Those would be tremendous boosts to our longevity and society, in general!
So if you are a woman in her early 40s and you want to be proactive for your future self, please consider making an appointment and discussing all the possibilities of early intervention.
Perimenopause: The Decade Where It ALL Changes
You read that right! Perimenopause can last about 10 years. We know women may go through subtle changes about 10 years before their last period. In some females, that means their mid-30s! Let’s talk about some of the symptoms you may experience in this time…
Early Perimenopause: This can start in your mid- to late-thirties into the early forties. Women’s cycles are regular but symptoms start to stand out like longer or worse PMS, anxiety may increase, sleep can change, and fatigue may worsen. It can also be indicated heavier periods. As this progresses, women may also experience mood swings, full-blown anxiety, night sweats and trouble sleeping.
Late Perimenopause: Typically, this starts in the later forties and women see more period irregularity, maybe even skipping periods. Changes in overall health can start showing up—like increased blood pressure, or cholesterol getting worse. Hot flashes, weight gain, night sweats, worsening joint pain, skin breakouts, even itchy ears can become problems. And often, women are told to deal with the symptoms, or that it is natural.
We don’t handle the loss or absence of hormones in this way with anything else in medicine! If our pancreas stops producing insulin, we have medications that we replace to provide the insulin. If our thyroid doesn’t produce thyroid hormones, we replace those. And as patients, we want to have a preventative strategy so things don’t become bigger problems, so clinicians who are trained in women’s midlife health know that intervening early and considering hormone therapy DURING perimenopause, not after, may be the best option.
Let’s talk what happens with a lack of estrogen in your body:
Inflammation increases: estrogen is literally the water on the inflammation fire. And inflammation can be the root of all evil, causing worsening atherosclerosis of our arteries, creating cellular change that can lead to cancers, and dysregulating mood and memory (which can lead to diagnoses of depression, anxiety, and dementia)
Heart Health: Cholesterol comes in many forms but the lack of estrogen can allow bad cholesterol to become a prominent part in causing an increased risk of heart disease…the number ONE killer of women!
Bone Health: Women become more fragile without estrogen. We start losing bone in our thirties but lose bone exponentially after the menopause transition and with total lack of estrogen. When we are looking at medication side effects, it may be wise to compare the osteoporosis meds that are often not prescribed until our 60s/70s to those of estrogen, which can be used preventitively!
Sexual Health: Vaginal dryness and decreased libido are issues that are often not asked about at yearly appointments but affect women’s lives greatly. Vaginal estrogen not only improves the possibly pain caused by menopause but GREATLY reduces the risk of UTIs-which in older age, can be cause for significant issues. And who doesn’t want a healthy sex life? Relationships feed on intimacy but if it doesn’t feel good or our brain is not in the right place, sex is generally the last thing we want to consider.
These are just a few of the hormonal changes that come about specifically due to estrogen. But testosterone and progesterone are affected too and the three in fluctuation can cause the body to go into complete chaos! In the coming weeks, we will talk about these hormones as well and what they help our bodies do, what happens when we don’t have them, and what our options are to replace them!
At Sapphire Wellness, we love to help women through this time of life and if you are ready to get off the roller coaster of perimenopause, or you aren’t sure if you are on it and what you should do, book an appointment and let us help you feel your best!
Perimenopause and Self-Care: The Dietary Shifts We Didn’t Know We Needed
If you have spent any time searching for more information on perimenopause, chances are, you’ve been bombarded by thousands of diet plans promising things that no diet plan has ever done for you before. The truth is…there is no perfect diet plan out there, but there are perfect types of nutrients to utilize in your daily meals. There is a shift that needs to be made and the following are the key components:
Protein: Protein is always a really important source of energy. It helps stabilize muscle mass and stabilizes blood sugar. Proteins exist in several forms…and it is not just meat! You can get protein from flaxseeds, soy (think tofu, edamame), lentils, chickpeas. It can be in salmon, sardines, walnut and chia seeds. Think of proteins as your safety net. They are the basis for which everything else is supported. Getting 30-40 grams of protein spread out throughout the day is the goal.
Fiber: If there was one thing that none of us are getting enough of, it’s fiber! We should be getting 25-30 grams of fiber per day. It is packed into nutrient-rich foods like vegetables, fruits, beans, nuts, and whole grains. If you want to help your gut biome, fiber is the first thing to add rather than probiotics. It helps bind cholesterol-rich foods, it helps us feel full. Fiber helps us stay regular so what goes in our mouths is utilized to its fullest potential and we get rid of it with no problems (think no constipation).
Other nutrients to consider: Calcium, Vitamin D, and Magnesium. If you read last week’s blog, you’ll know these guys show up a lot when we talk about diet and nutrients in perimenopause. Why? They support our bones, muscles, and brain. Getting calcium from things like diary, sardines, almonds and leafy greens helps us as we start to lose muscle mass. Fatty fish and a little sun exposure can be the easiest way to increase that Vitamin D (but supplements are probably necessary on this one). And magnesium can be found in leafy greens, beans, and pumpkin seeds.
These are the basics that should shape our meal planning. The foods available in these categories are vast, and tasty meals can have variety and amazing flavor. But who has time to figure all this out? Well, you’ve come to the right place! At Sapphire Wellness, you can join our email list and get a week’s worth of High Protein/High Fiber Meal Plans sent right to your inbox and a list that is ready to take to the store.
Sign up today to get on the path of true self-care, which mean planning for a healthy future!
Perimenopause and Self-Care: What Actually Works
It all begins with an idea.
In the world of perimenopausal health, everything seems complicated. Women are dealing with multiple symptoms and there are lots of “influencers” on the scene to solve their every ail! So, what is real? What works? And what should women really do if they are not yet ready for hormones but want to see some benefits?
Let’s start with supplements because, Lord knows, there are a thousand out there and if someone listened to every TikTok/Instagram/Facebook recommendation, the whole day would be spent taking pills (yep, with their own potential risks and side effects!). The Menopause Society has not endorsed any supplements for the treatment of perimenopause or menopause symptoms. But I will break it down into the 3 that I think are a good place to start and then one extra for all the girls with Hashimoto’s Thyroid problems.
Vitamin D. I cannot remember ever checking a patient’s Vitamin D levels, and barring them already being on supplements, having it in the optimal range of 50-60ng/mL. Vitamin D being low can make you feel fatigue and sometimes aid in brain fog. You can get it from the sun, but I’d rather you protect your skin than try to up it that way. So this means most women will need to supplement and getting around 2000 international units to 5000 international units per day is safe. Vitamin D is a fat soluble vitamin so you can technically overdose, but it is also slowly absorbed and therefore, as long as a patient is getting it checked, those dosages are safe. I have had patients note a significant improvement because of taking this as their only supplement. It may not be the only one you need, however!
Magnesium. This may be my favorite supplement. It’s versatile, coming in different forms, and it is generally well-tolerated. I had a friend who bought a shirt saying, “99 Problems and Magnesium fixed 98!” While that gave me a good laugh, magnesium may not be quite that accurate! You also must know the different variations of magnesium because they treat different things. Let’s look at the many forms that I recommend and what I use them to treat in my patients:
1. Magnesium Citrate: This can be found in a couple forms: liquid and pills. It is highly absorbable and is mainly used to treat constipation. It can increase a low magnesium number but it may also create a lot of number two…if you catch my drift!
2. Magnesium Glycinate: This is maybe my favorite of the magnesiums, although I love them all! It is the form that is well-tolerated, calms, helps with sleep, anxiety/stress, and muscle relaxation. I give it to patients with restless legs, new onset anxiety (that is not to a level where other meds need to be considered), and many women who share that they are stressed.
3. Magnesium Oxide: This form doesn’t absorb as well as some of the others and I will use for constipation as well, especially if Magnesium Citrate is causing diarrhea.
4. Magnesium L-Threonate: This is my go-to in the perimenopausal fogginess! This supplement offers cognitive support, memory help, focus, and brain health benefits. It is not going to treat/cure a dementia or a brain injury but it can certainly be a place to start when we start seeing small snippets of cognitive lapses.
There are more forms of Magnesium but I find these do most of the heavy lifting and the others are really used for very specific issues. If I was going to start on just one supplement, I would probably pick a form of magnesium.
Iron. Women are prone to iron loss because of menstruation. When we lose blood, iron dips and in the midlife when some women’s periods become heavier than ever, this can be a big source of fatigue, new onset restless leg syndrome, and decreased quality of life. A ferritin level is recommended as the source being checked, not just a hemoglobin or hematocrit (these are standard checks in your annual blood counts (generally ferritin and iron have to be ordered as add-ons). Ferritin literally means the iron IN your cells and if it is not there, it is not doing anything for you. I have seen numerous women with normal hemoglobin/hematocrit and REALLY low ferritin. So, adding iron may be helpful. Researchers are now looking at iron’s role in treating restless leg syndrome, which would be exciting if an element could be the answer to this issue that plaques so many!
And now for my women with Hashimoto’s Thyroid issues…Selenium. Selenium is something that has been study and there are some studies that point to the addition of Selenium helping with Hashimoto’s symptoms of fatigue, hair/skin/nail issues, etc. This does not mean that you should not take the meds your provider is recommending. In fact, you can add Selenium onto your med regimen.
So while there are a million and one supplements out there, many are not studied or don’t provide any robust improvements. However, these are a few that could be beneficial if you are looking for a place to start feeling better!
If you’d like to have a more thorough analysis of your vitamins and minerals, please make an appointment and Sapphire Wellness can get the right labs ordered and interpreted to get you started appropriately!
Follow back next week when we will continue on this self-care journey by discussing Perimenopausal Diet Shifts!
What Many Get Wrong About Menopause
If you are female and plan to live into your 60s, you WILL go through menopause! As old Ben Franklin is credited to say, “In this world, nothing can be said to be certain, except death and taxes!” But I would argue: death, taxes, and menopause (if you’re living beyond your early 50s). Women starting to actually talk about the issue, has jump started a revolution…one where women are taking control of their midlife health and aiming to have better quality of life through their 70s and 80s.
One of the many things that most get wrong about menopause is: When do symptoms start? The Myth: Menopause Starts In Our 50s
The answer to this question is: usually 10 years prior to actual menopause (a 12 month timeframe where you haven’t had a period/spotting).
For some women, this can mean symptoms start in their mid-30s! And often, when symptoms start this early, they are not addressed or are blown off at regular doctors’ visits. Things like feeling more fatigued, more anxious, achy shoulders, new inflammation, weight gain, changes in blood pressure readings or cholesterol despite not changing anything about your diet or exercise, just to name a few.
Why is this happening? The Myth: It’s Natural So You Just Have To Get Through It
Research reveals that estrogen receptors are everywhere in our body-in our brain, in our gut, in our blood vessels. Think of circulating estrogen like a cap on top of a boiling pan. As long as that cap stays on, there’s nothing to worry about (so inflammation is in better check, serotonin, insulin, and other circulating hormones stay in their regulated lanes), but when that estrogen level decreases and there are less caps on the boiling pan, things that weren’t a problem now become a problem. No longer are things staying tidy and in place.
Who can help me? The Myth: My GYN, PCP, or Endocrinologist Will Know What To Do!
Chances are…they don’t. Every medical provider is taught about menopause but the truth is, it is abysmally small amounts and generally doesn’t cover the many issues that women will face during the menopause transition and into their menopausal years. The general medical education usually gives clinician about 4 hours of dedicated menopause education. In 2017 the Mayo Clinic published a report that only 20% of OB/GYN residents felt “adequately prepared” to manage women in menopause! And another study found just 6.8% of all clinicians (remember estrogen receptors are everywhere!) felt adequately prepared to address menopause issues.
So, who are women supposed to see? The good news is we are starting to fill in this HUGE gap! Clinicians are seeing the value of having more education and a large thanks goes to the Menopause Society (NAMS) in North America and also our counterparts around the world. They offer trainings, continuing education and even certification to help clinicians be more informed in this area. Any woman with a computer/smartphone can search their database to find providers in their area. And if you are reading this, you have already found one! The menopause transition isn’t a one size fits all solution, women don’t have to just grin and bear all the potential issues they encounter, and how we handle the transition has a direct effect on how our quality of life is in our 70s and 80s.
Where do I start? The Myth: You Can Only Do Hormone Therapy and If You Do Hormone Therapy, It’s For The Shortest Time Possible, At The Lowest Dose.
The truth is, there is a wide range of options, hormone and non-hormonal, that can help women through this phase of life. We are getting new medications, like Veozah, to the market as we speak and with the Gen Xers not going quietly into menopause and much more social awareness of options, we will drive further breakthroughs in this category of meds. Supplements, diet and exercise, therapies like pelvic floor PT, CBT, and talk therapy have all been found to be helpful.
The truth is, you are an individual! Your transition into menopause is individual and what works for one person may not work for another. However, you deserve to have your concerns address and not be taken for granted! You deserve options to helping you thrive through this time of life! We are changing the way women will go through midlife for generations to come and it is so exciting to see my patients taking control of their health and really feeling better than they though was possible.
If you are looking for a provider that can really listen and hear YOUR issues and work to improve your health goals, book an appointment with Lisa today!