FDA removes HRT black box warning…

...and why that’s a very good sign

It took long enough, but the FDA is finally removing an infamous (and infamously flawed) boxed warning from menopausal hormone replacement therapy products, according to an agency press release that called the move “historic action.”

No longer will HRT products have to include warnings about an increased risk of cardiovascular disease, breast cancer, and dementia. Those were added in the early 2000s after the results of a study that, in the words of FDA Commissioner Marty Makary, “misrepresented [the data] and created a fear machine that lingers to this day.” 

The implication of the decision, and Makary’s comments, are encouraging signs for compounding. They suggest the agency, under his leadership, may be taking a more evidence-based, patient-centered view when it comes to compounded hormones. Specifically, we’re hopeful it signals the end of FDA’s reflexively lean on the discredited 2020 NASEM report to shape its position on compounded hormones.

As Makary put it, “HRT has saved marriages, rescued women from depression, [and] prevented children from going without a mother.” Hear, hear.