FDA reverses decades of guidance on hormone therapy for menopause
Consider This from NPR
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🗓️ 10 November 2025
⏱️ 12 minutes
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Summary
The FDA is removing the black box warning on estrogen therapy after two decades. Should it?
Women who want to use estrogen to treat menopause symptoms often face a difficult choice.
That’s because those hormone treatments contain a “black-box warning.”
The Food and Drug Administration uses black box warnings to indicate a medication has potentially life threatening side effects.
In the case of estrogen for menopause symptoms, an increased risk of endometrial cancer, cardiovascular disorders, dementia and breast cancer.
Well those warnings are going away.
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Transcript
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| 0:00.0 | About 20 years ago, the Food and Drug Administration added a black box warning to hormones used to treat menopause symptoms, symptoms that include night sweats, brain fog, weight gain, and urinary tract infections. |
| 0:13.5 | Prescriptions for hormone replacement therapy plummeted in the United States. Women flushed their pills down the toilet. |
| 0:23.6 | 50 million plus women have not been offered the incredible potential health benefits of hormone replacement therapy because of |
| 0:31.2 | medical dogma. That's Dr. Marty McCarrie, the FDA Commissioner. He was speaking at a July |
| 0:36.3 | panel about menopause and hormone |
| 0:38.1 | replacement therapy for women. The addition of that black box warning, the strongest to label |
| 0:43.2 | the FDA uses to warn of drug-related risks, came after a 2002 study by the Women's Health |
| 0:49.0 | Initiative, which found use of hormone replacement therapy led to higher risks of cardiovascular disease, |
| 0:55.6 | breast cancer, uterine cancer, stroke, and dementia. But over the last two decades, as more |
| 1:01.9 | and more studies have been done, many doctors say they know a lot more about how these medications |
| 1:07.2 | can help women. When we looked at all the data and not just the WHA, we realized that for |
| 1:12.9 | women who were under 60 or within 10 years of menopause, it was not only effective. It was safe and actually |
| 1:19.6 | had benefits on preventing heart disease, potentially preventing fractures, treating hot flushes |
| 1:25.6 | and night sweats. That's Joanne Pinkerton, a menopause specialist. |
| 1:29.9 | And she says she's seen how menopause affects women firsthand in her practice and how hormone |
| 1:35.8 | replacement therapy has helped. We prescribe these more contemporary hormones all the time. |
| 1:42.0 | And one of the most gratifying parts of my job is to take somebody |
| 1:46.3 | who's absolutely miserable who says, I can't think, I can't function. It's affecting my work. |
| 1:51.1 | It's affecting my relationships at home. I'm irritable. I'm snappy. I wake up four or five times |
| 1:57.2 | at night, covers on, covers off, having to change my clothes. And within, you know, |
| 2:01.9 | four to eight weeks, they are dramatically improved. Pinkerton says she has patients who pick up the |
| 2:07.3 | medication, read the black box label warning, and they get scared and decide not to use it. |
... |
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