US Health Officials Ditch Black Box Warnings for Hormone Therapy Treatments, Hoping to Boost Use
In a major shift, US health officials announced Monday that they will be removing warnings about the increased risk of breast cancer, heart disease, and dementia associated with hormone replacement therapy (HRT) products used to treat menopause and perimenopause symptoms.
The decision comes after decades of controversy surrounding HRT, which was initially linked to an increased risk of these conditions in a 2002 study known as the Women's Health Initiative. However, subsequent research has questioned the validity of this study, and medical associations have called for revisions to the labels.
According to FDA Commissioner Marty Makary, "We now have a more nuanced understanding" of HRT's risks and benefits, and want to put the fear surrounding it into perspective. He argued that hormone therapy is an effective treatment option for menopause symptoms, one that can improve women's health on a population level.
The updated labels will recommend HRT for patients under 60 or within 10 years of menopause onset, while estrogen-only products will still carry warnings about endometrial cancer. However, the FDA has also approved a new generic version of Premarin and a non-hormonal treatment for hot flashes.
Critics argue that the removal of these warnings is an "incredible step forward" to empower millions of women to live longer, healthier lives. With HRT replacing estrogen production in postmenopausal women, which typically ceases at age 52, systemic therapy and low-dose vaginal estrogen are two main treatment options.
The FDA's decision comes as a surprise, but experts say it is a much-needed shift towards balancing the risks and benefits of HRT. "Estrogen is a key hormone for women's health," notes Alicia Jackson, director of the Advanced Research Projects Agency for Health.
In a major shift, US health officials announced Monday that they will be removing warnings about the increased risk of breast cancer, heart disease, and dementia associated with hormone replacement therapy (HRT) products used to treat menopause and perimenopause symptoms.
The decision comes after decades of controversy surrounding HRT, which was initially linked to an increased risk of these conditions in a 2002 study known as the Women's Health Initiative. However, subsequent research has questioned the validity of this study, and medical associations have called for revisions to the labels.
According to FDA Commissioner Marty Makary, "We now have a more nuanced understanding" of HRT's risks and benefits, and want to put the fear surrounding it into perspective. He argued that hormone therapy is an effective treatment option for menopause symptoms, one that can improve women's health on a population level.
The updated labels will recommend HRT for patients under 60 or within 10 years of menopause onset, while estrogen-only products will still carry warnings about endometrial cancer. However, the FDA has also approved a new generic version of Premarin and a non-hormonal treatment for hot flashes.
Critics argue that the removal of these warnings is an "incredible step forward" to empower millions of women to live longer, healthier lives. With HRT replacing estrogen production in postmenopausal women, which typically ceases at age 52, systemic therapy and low-dose vaginal estrogen are two main treatment options.
The FDA's decision comes as a surprise, but experts say it is a much-needed shift towards balancing the risks and benefits of HRT. "Estrogen is a key hormone for women's health," notes Alicia Jackson, director of the Advanced Research Projects Agency for Health.
! It makes total sense that the warnings were outdated and not entirely accurate anymore. I mean, who doesn't want to empower millions of women to take control of their health? 
The FDA is finally recognizing that hormone therapy can be a game-changer for menopause symptoms and overall well-being. And let's be real, it's about time they updated those labels - all that fear-mongering was kinda scaring people off from something that could really make a difference in their lives 
. I know some doctors still talk about how HRT can increase breast cancer risk, but what if that's only true for older women? I think it's awesome that they're re-evaluating these treatments and making them more accessible 
. My mom actually just started taking low-dose estrogen and she says it's been a game-changer for her hot flashes 
. Let's hope this new approach helps empower even more women to take control of their health 
. They're basically rolling back warnings on hormone therapy treatments because they think it'll boost use. Like, what about all those risks to women's health? 
I don't want to see more cases of breast cancer and heart disease just to save a few bucks 
. And what's with the 60-year-old cut-off? Don't they know some women enter menopause way earlier than that? 
The FDA's trying to put a spin on this, but I'm not buying it 
. They're basically saying "estrogen is key" without even acknowledging the downsides...no thanks 
So I'm reading this news about US health officials ditching those scary black box warnings on hormone therapy treatments... like what's going on here? 
If we're removing warnings because we have a more nuanced understanding of HRT, that means there was some serious doubt about the risks in the first place, right? Like, they were questioning the validity of that 2002 study from years ago and now they're saying it was just a misunderstanding? 
And experts are actually super happy about this decision because it's supposed to empower women to live longer healthier lives... but isn't HRT basically just replacing one health risk with another? 
. This new generic version of Premarin sounds promising, though! Have you heard of those? They're supposed to be just as effective without all the fuss about heart disease and breast cancer. Not sure if I'd want to try it myself, but some women must be thrilled.
. but seriously, experts say this decision is a big step in acknowledging the benefits of hormone therapy for women's health 
. and its not just about the treatment itself, but also about empowering women to live longer and healthier lives 
. what do u think?
I know some of you are gonna say 'back in my day...' but trust me, I've got a friend who took HRT and she's still dealing with issues 
Especially considering all the controversy surrounding it for so long. What if there are still people who experience some serious side effects from using these hormone therapy products? 
so now they wanna make it sound like its more safe than it used to be lol just 10 yrs ago we were dyin from all the warnings lol anyway i think its cool that they r tryin to make it easier 4 ppl 2 get treatment but at da same time im a lil worried cuz what if its still bad 4 some ppl?! 
. And let's be real, most of the women who take HRT are going to be over 60 anyway