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The Many Problems With the FDA’s Big Menopause Announcement

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HHS Secretary Robert F. Kennedy Jr., left, and FDA Commissioner Marty Makary, right, announced changes to the labeling of hormone replacement therapy for people in menopause on Monday.Tom Williams/CQ Roll Call/AP

On Monday, the Department of Health and Human Services made an announcement that it promised would change the lives of millions of American women for the better: Hormone replacement therapy, the combination of hormone drugs that can treat the symptoms of menopause, was about to be depathologized.

The Food and Drug Administration (FDA) had decided to remove a black-box warning on the medication that cautioned patients that its use could cause cancer and stroke. HHS Secretary RFK Jr. and FDA commissioner Marty Makary said that the warning, which first appeared in 2003, had been based on an overblown interpretation of a decades-old study. “The FDA is announcing today that it will remove the misleading black-box warnings from all HRT products,” said Kennedy. “For the first time in a generation, the FDA is standing with science and standing with women.” 

“For the first time in a generation, the FDA is standing with science and standing with women.” 

The change was welcome news to many doctors who treat the often-debilitating and long-dismissed symptoms of menopause: hot flashes, brain fog, insomnia, and recurrent urinary tract infections, to name but a few. “This decision aligns with the latest evidence-based research and helps eliminate the unnecessary fear that this warning has long perpetuated,” the Menopause Advocacy Working Group, a group of physicians that promotes increased awareness around menopause, said in a statement on social media. (Two of the group’s members were among the speakers at Monday’s event.)

But the specialists with whom Mother Jones spoke said that Monday’s panel, which included doctors with robust social media presences, had at times overstated both the negative health effects of menopause and the science on the benefits of hormone replacement therapy. Spokespeople for HHS did not immediately respond to questions for this story.

Here are just a few of the more questionable claims they made:

Menopause causes divorce.

Dr. Kelly Casperson, a urologist and “expert and advocate for sexuality and hormones,” warned that “families fracture” if women don’t get treated for the symptoms of menopause. Dr. Makary listed “divorce” alongside well-documented symptoms like mood swings and hot flashes. For

© Mother Jones