Hormone therapy for menopause symptoms to lose cancer and heart disease warnings, FDA says.
A major overhaul is underway in hormone replacement therapy (HRT) labels. The US Food and Drug Administration announced that black box warnings will be removed from products prescribed to treat menopause, citing "misinformation." These warnings had discouraged women from using HRT for years.
In the 2002 Women's Health Initiative study, researchers linked HRT to an increased risk of cancer and stroke. This led to a sharp decline in HRT use, with less than 5% of postmenopausal women taking the therapy in 2020. However, subsequent research has challenged the study's design and conclusions.
An FDA expert panel, convened last year, recommended revising the labels. Medical associations, such as the American Urogynecologic Society and American College of Obstetricians and Gynecologists, also weighed in, supporting changes to low-dose vaginal estrogen treatments.
The updated labels will recommend HRT for women under 60 or within 10 years of menopause onset. Estrogen-only products, however, will still carry a warning about endometrial cancer.
In a significant move, the FDA is approving new drugs that treat menopause symptoms. A generic version of Premarin and a non-hormonal treatment for hot flashes are among the approved treatments.
HRT replaces estrogen production after menopause, which typically occurs at age 52. Two types of therapy exist: systemic and low-dose vaginal estrogen. Systemic therapy is used to treat various symptoms and is administered through pills, patches, rings, or creams. Low-dose vaginal estrogen targets vaginal and urinary symptoms, with less estrogen than systemic therapy.
The FDA's decision aims to "put the fear machine in its proper context," according to Commissioner Marty Makary. The agency believes HRT can improve women's health on a population level more than any other medication.
The removal of black box warnings marks an important shift towards empowering millions of women to live longer, healthier lives, says Alicia Jackson, director of the Advanced Research Projects Agency for Health.
A major overhaul is underway in hormone replacement therapy (HRT) labels. The US Food and Drug Administration announced that black box warnings will be removed from products prescribed to treat menopause, citing "misinformation." These warnings had discouraged women from using HRT for years.
In the 2002 Women's Health Initiative study, researchers linked HRT to an increased risk of cancer and stroke. This led to a sharp decline in HRT use, with less than 5% of postmenopausal women taking the therapy in 2020. However, subsequent research has challenged the study's design and conclusions.
An FDA expert panel, convened last year, recommended revising the labels. Medical associations, such as the American Urogynecologic Society and American College of Obstetricians and Gynecologists, also weighed in, supporting changes to low-dose vaginal estrogen treatments.
The updated labels will recommend HRT for women under 60 or within 10 years of menopause onset. Estrogen-only products, however, will still carry a warning about endometrial cancer.
In a significant move, the FDA is approving new drugs that treat menopause symptoms. A generic version of Premarin and a non-hormonal treatment for hot flashes are among the approved treatments.
HRT replaces estrogen production after menopause, which typically occurs at age 52. Two types of therapy exist: systemic and low-dose vaginal estrogen. Systemic therapy is used to treat various symptoms and is administered through pills, patches, rings, or creams. Low-dose vaginal estrogen targets vaginal and urinary symptoms, with less estrogen than systemic therapy.
The FDA's decision aims to "put the fear machine in its proper context," according to Commissioner Marty Makary. The agency believes HRT can improve women's health on a population level more than any other medication.
The removal of black box warnings marks an important shift towards empowering millions of women to live longer, healthier lives, says Alicia Jackson, director of the Advanced Research Projects Agency for Health.
. It's been a while since I've known any women in my family who were on HRT and they didn't seem to have any major issues. My sister actually just started taking it last year for her hot flashes and she's doing pretty well 
. It's good that the FDA is revising the labels to reflect more accurate info – it's not like we want people to be scared off from getting help if they need it 
. I do wish they'd consider including more info on the benefits of HRT for heart health, though 
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just saw this news about hormone therapy for menopause symptoms and I gotta say... it's about time! 
. losing cancer and heart disease warnings as black box labels? that's a huge deal in my book! 
I mean, who wants to live in fear of taking care of their own health? 
anyway, I'm all for giving women more options when it comes to managing menopause symptoms 
and those new approved treatments sound like a game-changer 
. Now, with the FDA approving new treatments and revising labels, I'm hopeful we'll see more women benefiting from these therapies 
It's about time we had a better understanding of hormone therapy and its benefits. The FDA is totally on point with these changes. 5% of women taking HRT in 2020 is crazy low, like what's going on? 
I'm all for the new approved treatments too, especially that non-hormonal hot flash treatment - game changer! 
, I wonder what other changes are coming down the pipe with these new labels... And yay 
, more treatment options for hot flashes and stuff! But what about all the women who've already stopped taking HRT because of those old warnings? Are they gonna start using it again now?
... I mean, think about it, the whole point of black box warnings was to protect people from harm, and now they're just gonna ignore that? Like, what if some woman in her 50s decides to use HRT because she's got anxiety or something, and then BAM! She gets cancer or a heart attack? It's not like we've been able to accurately measure the long-term effects of HRT for decades... and now they're just gonna start handing out prescriptions like candy? 
The risk is still there, I don't think we can just ignore it.
. But now the FDA is saying that the risks are being blown out of proportion and that HRT can actually be a game-changer for millions of women. I'm all for empowering women to take control of their health, especially when it comes to something like menopause. The new labels make sense - low-dose vaginal estrogen is a safer bet for women who just need some relief from vaginal dryness or hot flashes 
! It's like they're still stuck in the 2002 study that was totally debunked. I mean, come on, a sharp decline in HRT use due to those warnings didn't even help women with actual symptoms, it just left them feeling frustrated and unsupported. And now we're being told that it's okay to try again? 
. And what about the new meds being approved? Are they really going to be safer than these old HRTs? I don't know... something doesn't add up 
! I know how scary and stigmatized HRT can be, but this change of heart by the FDA is a huge step forward for women's health. It's amazing that they're acknowledging that there was misinformation in the first place, and now we have more options to manage our symptoms