344. BONUS Episode! Historic FDA Label Change!

You Are Not Broken

Kelly Casperson, MD

Medicine, Health & Fitness

4.8 • 1.1K Ratings

🗓️ 11 November 2025

⏱️ 45 minutes

🔗️ Recording | iTunes | RSS

🧾️ Download transcript

Summary

THE WORLD IS CHANGING!!! Erasing fear with evidence, science and facts! This conversation delves into the significant impact of hormone replacement therapy (HRT) on women's health, particularly in the context of menopause. Dr. Rubin, Casperson and Makary discuss the recent FDA decision to remove black box warnings associated with HRT, which have perpetuated fear and misinformation for decades. They emphasize the importance of educating both clinicians and patients about the benefits and risks of HRT, highlighting the long-term health advantages it offers, such as reducing the risk of heart disease and osteoporosis. The discussion also addresses the need for informed consent and the importance of empowering women to make educated decisions about their health. Takeaways 50 to 70 million women have been denied health benefits from HRT. The FDA's removal of black box warnings is monumental. Misconceptions about HRT have persisted for decades. Education is crucial for both clinicians and patients. Hormone therapy can significantly reduce heart disease risk. Women often face barriers in accessing HRT. Informed consent is essential for women's health decisions. Long-term benefits of HRT include reduced risk of osteoporosis. The healthcare system needs to better address women's health issues. A collaborative approach is needed to improve women's health outcomes. FDA DIRECT podcast Dr. Makary's "Blind Spots" book To my fellow clinicians: listen to this podcast on ⁠⁠⁠Pinnacle for FREE to earn CME credit⁠⁠ Listen to my Tedx Talk: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Why we need adult sex ed⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Take my Adult Sex Ed Master Class:⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠My Website⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Interested in my sexual health and hormone clinic? ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Waitlist is open⁠⁠⁠⁠⁠⁠⁠⁠ Learn more about your ad choices. Visit podcastchoices.com/adchoices

Transcript

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0:00.0	Hey friends, welcome back to the You Are Not Broken podcast. I'm so excited to share this bonus episode that is coming out midweek because of the huge landmark, amazingly awesome decision by the FDA to recommend a significant change to the boxed warning of both systemic and vaginal estrogen products, completely removing the box warning
0:22.8	from vaginal estrogen products as well.
0:25.7	So just so people understand, all FDA approved products and prescription products have warnings,
0:31.5	risks and benefits on them.
0:32.9	But the boxed warning, previously called the black box warning, the boxed warning is for significant
0:39.3	potential to threat of life or significant adverse actions. So basically what we're doing
0:47.2	is preserving the sanctity of the boxed warning by removing the mistruths from the WHOI for a big
0:54.0	history on this, listen to this podcast, and
0:57.4	check out my awesome book, The Menopause Moment, where I go into it in more detail. But in short,
1:03.1	we basically applied apples to oranges, and we discussed that in this podcast of how oral synthetic
1:09.1	medications and the risks and benefits from the
1:12.6	Women's Health Initiative was blanket applied to a naturally occurring estradiol, both transdermal,
1:18.6	oral and vaginal with absolutely no evidence that the same risks applied. So this has been 20
1:25.1	years in the making. We stand on the shoulder of giants.
1:28.7	Citizens petition went out over a decade ago. FDA took a very long time to finally review the
1:37.2	evidence which they have done this summer. Go check out the FDA's YouTube channel to watch
1:42.3	this summer's amazing hormone roundtable where I was lucky
1:46.5	enough to be included in the about 10 clinicians who each gave five-minute talks. So for more
1:52.1	education, go listen to that on the FDA YouTube. And thank you to the FDA and Dr. McCarrie's
1:57.9	amazing team for sharing this audio for my podcast because I have a huge
2:03.1	listenership and this is going to go out to tens of thousands more people because this audio
2:08.1	was allowed to be put on the You Are Not Broken podcast for more news and up to date things
	...

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