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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