(NEW YORK) — The Food and Drug Administration said Monday it will remove the “black box” warning from hormone replacement therapy (HRT) products for menopause.
The change comes after two studies in the early 2000s claimed that there were major risks associated with HRT, including breast cancer. This led to the FDA placing its highest warning label on the drugs, prompting a significant decline in usage.
The public health agency estimates millions of women have avoided HRT out of fear of cancer or heart risks, based on an outdated analysis of data.
“This is, in my opinion, one of the greatest mistakes in modern medicine — the demonization of hormone replacement therapy,” FDA Commissioner Dr. Marty Makary said on Monday.
An expert panel formed at the FDA in recent months reviewed the latest scientific studies and recommended the removal of the warning, Makary explained.
“Hormone replacement therapy may improve the health outcomes of women at a population level more than any other intervention, arguably, with the exception of, say, antibiotics or vaccines,” Makary said.
The timing of when women initiate HRT “is an important nuance that has been lost” and “one of the design flaws” of the early 2000s studies Makary said.
Current understanding is that the benefits of HRT outweigh the potential risks when taken before age 60 or within 10 years of the onset of menopause.
“This is really the result of doctors waving a flag in the air for decades of women who have said, ‘Hey, we didn’t feel like we got the right information,"” Makary said.
Consumers will see a different label on the products in several months, he added.
There are still risks associated with HRT and women considering it should speak with their doctor as it requires a prescription.
This is a developing story. Please check back for updates.
Copyright © 2025, ABC Audio. All rights reserved.
