FDA Removes Misleading HRT Warnings: What Every Woman Should Know About Hormone Therapy
Nov 23
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Just over a week ago, a news release from the FDA announced that the U.S. Department of Health and Human Services will remove the inappropriately applied Black Box warnings from hormone replacement therapy products.
I’ve had multiple patients who elected to start vaginal estrogen therapy, often for genitourinary syndrome of menopause (vaginal dryness, urinary symptoms) which can also lead to painful intercourse, only to pick up the prescription, read the label and not use the medication due to
this warning.
It was so frustrating, not because of the patient, but because my ability to take care of her outpaced the government's ability to stay up to date.
On the flip side, I recently had a long discussion with a patient about starting HRT. She had lots of questions, including breast cancer. It’s top of mind for most patients having this discussion. She was going to consider her options. She sent a message to me later that day after she saw the FDA press release and decided to start HRT.
These warning labels have far-reaching impact. They are very influential in the decisions women make for themselves. Women have great ability to make good decisions, but these good decisions require accurate information. Now, we finally are making headway.
What is a Black Box warning?
A boxed warning is on the handout that comes with your medication. You know, that pamphlet after you pick up a medication that lists all the bad things that can happen. These are put in place by the FDA.
What did the warning say?
This warning was initiated after the Women's Health Initiative which was published in 2002 which notoriously and unfortunately publicized women out of hormone therapy for now over two decades.
The warning "cited risks of cardiovascular disease, stroke, blood clots, invasive breast cancer, and probable dementia, based on the Women's Health Initiative (WHI) study”.
Why was this inappropriate?
So many reasons.
The WHI was a trial designed to see if women on hormone replacement therapy (HRT) would have decreased cardiovascular disease compared to those not on HRT.
#1. The hormones of the WHI are not what we use today.
They were using synthetic medications: conjugated equine estrogen (estrogen from horse urine) and medroxyprogesterone acetate.
These are NOT the bio-identical hormones we use today.
#2. In one group, there was a non-significant increase in breast cancer with no increase in breast cancer deaths.
The part heard around the world was: increase in breast cancer.
This was then translated into: hormones cause cancer.
#3. The warning was then applied to all hormone products, including vaginal estrogen. We now know that vaginal estrogen has limited systemic absorption, however the warning remained until recently. There is even a role for vaginal estrogen in its lowest dose for some breast cancer survivors based on updated data.
What are the benefits of HRT?
I have copious articles about the benefits of HRT. To name a few, if started with appropriate timing, HRT can lead to:
Decreased cardiovascular disease
Decreased osteoporosis
Decreased dementia
These are in addition to improved quality of life, reduction or elimination of hot flashes and night sweats, improvement of mood, improved vaginal dryness and intercourse, and the list goes on. I hear the benefits continuously when patients return to me after starting an HRT regimen.
While many in the population, including in the medical field, are critical of Robert F. Kennedy Jr. (Secretary of HHS) and Marty Makary (FDA commissioner), this is an honorable move in women's health after decades of stagnation and apathy toward caring for midlife women. It's an absolute champion effort. Dr. Marty Makarty has an entire chapter on HRT in his book Blind Spots which I encourage anyone interested to read.
I am so happy and grateful to be in this field at this time, passionate about this area with the knowledge and ability to change the lives of women in a way that's long overdue.
Resources:
Some of the information contained in this article is the result of my training, medical knowledge, and personal experience without a specific source to be cited.
The author can earn commissions through affiliate links.
Disclaimer: This is not medical advice. This is for educational purposes only. Discuss with your
doctor.
https://health.clevelandclinic.org/what-does-it-mean-if-my-medication-has-a-black-box-warning
