FDA + Black Box Warning on Estrogen Meds
You guys, this is big.
As a perimenopause girly who’s got her hormone replacement convo with a holistic midwife booked STAT, I love this for me. But I also love this for you if you’re in the silly grey area between ‘am I pregnant’ or ‘is this perimenopause playing in my face?’
Here’s the tea…
The FDA is removing the black box warning from most menopause hormone replacement therapy (HRT) products, which reverses a 2003 decision founded on the prominent and widely cited Women's Health Initiative (WHI). This breakout news takes newer studies into heavy consideration, based on new scientific reviews. This almost never happens – it can take up to 17 years for research to make it into mainstream conversation alone.
There was a significant problem with the WHI study – participants averaged 63 years of age, more than 10 years older than the average onset of menopause. As a consequence, up until now these black box warnings cited cardiovascular disease, breast cancer, and probable dementia, which would no doubt scare anyone; but it’s deeper than that. These black box warnings inadvertently gaslit women into thinking ‘hey, my symptoms aren’t so bad’ or ‘I could live with this because omg breast cancer is so much worse.’ And, with the war on women’s bodies we need less of this. Menopause is bad, too.
Shockingly, they’ve taken a step back to reflect the current understanding of HRT risks and benefits, though, the warning for endometrial cancer on estrogen-alone products will remain.
The FDA now says a comprehensive review of the science indicates a more nuanced view is needed (wowzers), and the original warning was based on a "flawed and incomplete" understanding of the risks and benefits. New literature indicates women who start HRT within 10 years of symptom onset actually show improved mortality, fewer bone fractures, and retained cardiovascular health.
Listen, science is science. It’s often, nearly always contradictory because it’s set up that way. But when we can step back and look for ways to make it work in our favor, expand access and treatment options for millions of women, we’re doing it right.
The goal is to ensure women and physicians have a more complete and accurate picture of HRT, which can provide benefits like relief from hot flashes and night sweats. Because, miss me with that.