UK HealthCast: What to know about the lifting of FDA warnings on hormone replacement therapy.
UK HealthCast is a podcast series featuring interviews with UK HealthCare experts on a variety of health-related topics.
The U.S. Food and Drug Administration recently lifted its warning on hormone replacement therapy.
Erica Marnatti, APRN, MSCP, joined UK HealthCast to discuss the lifting of the warning. Marnatti is a Menopause Society-certified practitioner in UK HealthCare's Women's Health Internal Medicine Clinic.
Watch the conversation below or continue reading for a summary of key takeaways.
What does the FDA's removal of the black box warning actually mean for women?
This is a really big deal, because the FDA finally removed an outdated warning that scared a lot of women and providers from prescribing hormone therapy. What it really means is that women can start making decisions based on the updated science instead of old fear.
It doesn't mean that hormone therapy is perfect for everyone. We still are individualizing it based on age, timing, and health history. But overall, this opens the door for more women to consider treatment if they're good candidates, and it gives providers a lot more confidence to have these conversations.
Why did the FDA place the black box warning in the first place?
It all goes back to the early results of the Women's Health Initiative (WHI) in 2002. The headlines at the time made it sound like hormone therapy drastically increased risk for heart disease, stroke, blood clots, and breast cancer.
So, the FDA added the strongest warning they had, the black box warning, and the use of hormone therapy dropped almost overnight. Women literally flushed their hormones down the toilet.
But here's the catch: The average age of women in the WHI was 63. Most were over 10 years past menopause when they started hormone therapy. And this study used older synthetic hormones, which is different than what we typically use today, which are the bioidentical estradiol, and progesterone.
When experts went back and they reanalyzed the data, it became clear that the risks were much more nuanced.
