FDA to Remove Misleading Warnings on Hormone Replacement Therapy Products
Ladies! Trust me, you’ll know the difference between waking up hot and having a night sweat. Talk to your doctor!
The FDA wants to remove warning labels from hormone replacement therapy (HRT) products for perimenopause and menopause.
“Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk,” said FDA Commissioner Marty Makary. “For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.”
Since 2002, the FDA has placed these “black box” warnings after a Women’s Health Initiative study that found a statistically nonsignificant increase in the risk of breast cancer diagnosis.”
The thing is… the average age of the women in the study was 63. They also used products “no longer in common use.”
Many women experience these symptoms decades before that!
The FDA reached its decision after reviewing recent literature, convening an expert panel, and considering public comments.
Officials hope to “update language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia.”
However, the FDA wants to keep the “warning for endometrial cancer for systemic estrogen-alone products.”
“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” stated HHS Secretary Robert Kennedy. “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”
The FDA has also approved two new drugs for symptoms and a non-hormonal treatment:
In addition to the removal of boxed warnings, the FDA is also approving two new drugs to expand treatment options for menopausal symptoms. The first is the approval of a generic version of Premarin (conjugated estrogens), the first such approval in more than 30 years for this widely used hormone replacement therapy. The new generic product is expected to improve affordability and access while maintaining the same quality, safety, and effectiveness as the brand-name drug.
The second approval is for a non-hormonal treatment for moderate to severe vasomotor symptoms, such as hot flashes, associated with menopause. This option provides relief for women who cannot or choose not to use hormone therapy.
I’m so glad we’ve started to split the stages of this cycle in our lives.
I do not care if you think this is too much information. This is essential information.
We don’t go straight to menopause. The first stage is perimenopause, which is what I am in right now.
Menopause is when a female doesn’t have a period for 12 straight months. Our ovaries do not release eggs, and we cannot get pregnant.
Postmenopause is when our estrogen is consistently low. The symptoms we experienced during perimenopause and menopause start to disappear.
I started experiencing night sweats a few years ago when I was 41. It became a regular occurrence late last year.
Men, let me explain. You wake up soaked (I mean SOAKED) in the middle of the night, freezing because you lost all your body heat. Your clothes and linens are soaking wet. It’s hard to fall back asleep even though you change the sheets and clothes. Thank GOD for cooling bed pads.
Also, thank God when I spoke to my OB-GYN, he didn’t hesitate to put me on estrogen and progesterone, which has helped a lot. The cooling pad has helped the most (Ladies, it’s from Perfectly Snug! Expensive but WORTH IT), but when I travel and don’t have it, the night sweats aren’t that bad.
I’m glad I nipped it in the bud before I started regular hot flashes and lack of sleep.
Without these hormones, we risk weaker bones, cardiovascular diseases, and Alzheimer’s.
Hormones help ward off these issues.
LADIES. Please talk to your doctors. Do not go through this stage without help. It SUCKS.
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Comments
Sorry
This is BS, estrogen will feed cancer and if you are a woman and have had cancer
Don’t do it, a good nights sleep is not worth the hell you will endure
Breathing feeds cancer Dr G 😂😂
Well if estrogen feeds cancer most women would be dead around age 30. Some receptor positive cancers yes. The Womens health study used premarin, a soup of horse estrogens. Estradiol, not the soup, seems to cause far fewer problems. I’m happy with the new recommendations
A lot of doctors will only prescribe HRT for 2-5 years while trans women are allowed to stay on it for life. When your go off, your hormones drop like a rock and there are all sorts of nasty side effects. The medical field is way behind when it comes to treating menopause and post menopausal women. After all, we’re past our childbearing years so who cares if we have osteoporosis, thinning skin, incontinence, CVD, insomnia… the list goes on and on… all caused by a lack of estrogen.
Depending on who you ask, HRT can also increase the risk of CVD.
By the way, men get those problems too. Thinner skin check, insomnia check, osteoporosis later than women, CVD earlier than women, and prostate problems that
You can’t just treat away all of the effects of old age.
The change in men is slower, over decades. For women, it’s just a few years and it’s like falling off a cliff.
While that’s true, the change in men for CVD risk is considerably (40-50) earlier than women (60-70) and the prostate will develop cancer or at the very least, abnormal growth…it’s practically a guarantee if a man lives long enough (80+). Women after menopause have a lower risk of cancer when estrogen is gone but a higher risk of CVD and osteoporosis (and again, HRT does influence these risks…let me explain).
The FDA is saying there’s no INCREASED risk of female cancers with HRT, but it’s all in the phrasing.
It’s true that the risk of cervical/breast cancer doesn’t go UP compared to the “good years”. However, a woman is already at higher risk during those years.
if you go on HRT after menopause, your risk stays the same as the “good years” but is higher than if you are post-menopausal without HRT. Women are less likely to develop cancer after menopause if they stay off HRT.
CVD is a little bit unsettled.
My sister had a quarter of an ovary left after a hysterectomy, to produce estrogen.
When she was in her 60’s, her libido was not good so her Dr put her on estrogen…
3 months later she had incurable ovarian cancer
O had breast cancer , estrogen positive
I can not have any estrogen and in fact take anastrozole to make sure of it.. 9 years of thinning hair, insomnia, bones ok,
But I’m alive. If I take estrogen, I feed the devil
Probably a lot of other things in play for a woman of that age G.
No it ws the estrogen
There a reason your body stops producing it for the most part
Yes, I would love thick hair, good nights sleep and thicker skin
But I like living too
It would be impossible to blame a single thing when we hit that age. We all should love living and just live instead of being afraid of everything that could cause cancer (hint, pretty much everything causes cancer these days apparently 🤷♂️).
So youve been tested endlessly and results were the estrogen is the devil
Good to know
No, there is a direct link between high estrogen and cancer of the female mammary and uterine tissues. But you do have problems either way, menopause also increases CVD risk just by way of lowering estrogen. The HRT doesn’t lower the risk, but it doesn’t seem to raise CVD risk either (which is why I said the jury is still out on that one above).
Just like there is a direct link between high androgens and risk of stroke, heart attack and prostate cancer and there is also a link between low androgens and risk of stroke and heart attack. Men will get a higher risk of CVD even before their androgens drop with age.
I don’t understand why you are so happy about removing warnings. Medicos don’t really care about them and patients want what they want and ignore the consequences. This article also says they have new drugs to add . First do no harm. Remember the ‘rona travesty and pause and think before you take these drugs.
Read this important book:
https://www.amazon.com/This-Your-Brain-Birth-Control/dp/B07Y3ZZGNZ/