A unanimous panel, including the FDA commissioner, says the black box warnings are outdated and need to be removed by the FDA.
NEW ORLEANS — Some doctors say women’s health is being harmed because they are not being informed about the latest safety studies on hormones.
They say the black box warnings are outdated and need to be removed by the FDA.
And recently, a panel with the FDA commissioner unanimously recommended that it be removed.
“It’s also been found to reduce cognitive decline by up to 64 percent and, in one study, reduces the risk of Alzheimer’s by 35 percent,” said FDA Commissioner Dr. Marty Makary.
At a recent FDA panel, the commissioner and expert doctors in hormone replacement after menopause gathered to dispel myths that all HRT is dangerous. They focused on both local vaginal creams and full-body hormones.
“There is a black box warning even though the North American Menopause Society and the American College of OB-GYN has called for removing it. We discovered there is a black box warning on systemic estrogen, even though no clinical trial has ever found an association between hormone replacement therapy and an increase in breast cancer mortality,” he continued.
“I poured over the research only to find something earth-shattering that history got it wrong when it comes to menopausal hormone therapy,” said Dr. Heather Hirsh, an internal medicine physician with Health by Heather Hirsh.
“Testosterone is the most abundant gonadal hormone in the body, and women deserve access. The science is solid, and the need is undeniable. Picture 108 million women energized, focused, and ambitious, not in spite of their age, but because they are supported through it,” said board-certified urologist Dr. Kelly Casperson.
“It’s just been a disgrace much less the quality of life,” said gynecologist Dr. Stefanie Schultis, of Covington.
She treats patients with personalized hormone replacement for each. The black box warning has even scared her patients away from using just the vaginal cream that doesn’t get into the bloodstream.
“It’s clear that it helps with the atrophy, and the aging that occurs in the pelvic floor, the increase in genital urinary infections, particularly urinary tract infections that can lead to sepsis and death, and unable to have intimate relationships in many cases without the use of vaginal estrogen. Unnecessary testing for frequency of urination incontinence bladder, over activity. All of those things can be better on vaginal estrogen,” said Dr. Schultis.
Now there is no one-size-fits-all. Many factors need to be considered with your doctor. When did menopause start? What is the patient’s age? Is the patient much older and already has heart disease?
There is a 50 percent reduction in fatal heart attacks when started early.
But the bioidentical hormones of today are different than 25 years ago. And localized creams are safe. The problem is that most doctors have little to no training in hormone replacement and have not kept up with the latest safety data.
It’s a discussion for younger women, too.
Think about women who have hysterectomies at a younger age, and women at 40 can begin perimenopause. So, they need hormone support as well.
The entire two-hour panel gives simplified information. Doctors report that some women have thrown away even their creams due to the black box warning.
You can watch the entire discussion from July 17 here:
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