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HHS Removes Warning Labels from Menopause Drugs and Starts Selling Them as Safe
The Department of Health and Human Services announced Monday that it will remove long-standing warning labels from hormone replacement therapy (HRT) for menopausal women, saying the previous cautions were based on outdated studies.
By removing the warning labels, HHS is effectively rebranding hormone therapy as safe and, dare I say, marketing it to women.
Do they have new data to do this? No. They had an FDA Panel though where experts re-examined the evidence and decided that earlier cautionary labels were “misleading.”
The previous warnings date back to the Women’s Health Initiative study from the early 2000s, which linked combined hormone therapy to an increased risk of breast cancer. HHS now says that research was outdated and overly broad. But the association between HRT and breast cancer has not been disproven. Newer studies have refined the risks by age, timing, and formulation, yet none have definitively shown that long-term HRT use is without danger.
HRT also carries other well-documented contraindications, including an elevated risk of blood clots, stroke, and cardiovascular events, particularly in older women or those with certain preexisting conditions.
Another issue is that there’s no medical consensus on if or when a woman should stop taking it. While the North American Menopause Society and the Endocrine Society emphasize individualized care, there’s still no evidence-based protocol for safely discontinuing therapy, only the general recommendation to “use the lowest effective dose for the shortest duration.”
This is a profitable change for Pfizer and Novo Nordisk. Just last week, the Trump administration announced a deal to expand access to their weight loss drugs too. How great for them! Another windfall wrapped in the language of “women’s health.”
Of course, loss of estrogen comes with its own set of risks, which is why women deserve to be told the full story and I am here to give it to you straight ladies. Here is what the data says about HRT: You may be screwed if you don’t. You may be screwed if you do.
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