FDA Pulls Warning Labels From Hormone Replacement Therapies - podcast episode cover

FDA Pulls Warning Labels From Hormone Replacement Therapies

Nov 13, 20258 min
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Episode description

Hormone replacement therapies (HRTs) used to treat menopause symptoms no longer need to carry strict warnings about some potential side effects, including cancer and heart disease, the US Food and Drug Administration announced Monday. Commissioner Marty Makary said the agency is asking drugmakers to remove the strict black box warnings, with the goal of encouraging more women to take them. Labels on the medicines currently list potential side effects including cardiovascular disease, blood clots, breast cancer and dementia.

Fanny Elahi, MD, PhD is a physician-scientist and Associate Professor in the Departments of Neurology, Neuroscience, and Pathology at the Icahn School of Medicine at Mount Sinai in New York City. Dr. Elahi discusses the implications of this move and the importance of such therapies, particularly for women approaching menopause, with Carol Massar and Tim Stenovec on Bloomberg Businessweek Daily.

See omnystudio.com/listener for privacy information.

Transcript

Speaker 1

Bloomberg Audio Studios, Podcasts, radio News. You're listening to Bloomberg Business Week with Carol Masser and tim Stenoveek on Bloomberg Radio.

Speaker 2

We want to get to our weekly segment, BusinessWeek Women's Health segment, where we focus on key issues in developing technologies impacting the present and future of women's health around the world. And a lot of times it's women's health, but also even more generally a look at major health issues.

And this week, though definitely pertains to women, we're talking about hormone replacement therapies used to treat menopause symptoms no longer needing to carry strict warnings about some potential side effects, including cancer and heart disease, that came from the US Food and Drug Administration earlier in the week, actually on Monday it came. So we wanted to get to a voice that we've talked to before, and it's great to have her back with us.

Speaker 1

Doctor Fanny Lawi is Associate Professor of Neurology and neuroscience at the Icon School of Medicine at Mount Science and now she joins US from New York City. As Carol mentioned, this week, the FDA said it would remove the black box warnings from HRT products. The last time you're on the show with us, you said HRT may actually help diminish women's risk of dementia. What are your views on just the warning or the changing warnings coming from the federal government on this net a good thing.

Speaker 3

So I want to qualify that statement by I hope that it will diminish the risk of dementia. I am delighted by the fact that this warning that I and many others think was never warranted, was finally lifted. It's sad that we lost two decades, and during this time many women did not get the chance to go on hormone replacement therapy due to the fear of the side effects that were not indicated.

Speaker 4

But I think now we need to make.

Speaker 3

Up for the lost time and advance the science to the point where we are more precise with our predictions.

Speaker 1

Were those statements there in the first place? If we go back in history, you said we lost it's unfortunate that we lost twenty years of treatment here, Why do those come around in healthcare in the US?

Speaker 3

In the first place, it was unfortunately a flawed design. Hormone replacement therapy was started for women who had gone through metopause in their fifties, and it wasn't until mid sixties that hormone replacement therapy was started.

Speaker 4

By then, it's too late.

Speaker 3

The physiology has drastically changed, A decade has gone by, and the impact of hormones may no longer. The hormones may no longer have the impact on the health span that we need them to have, and then you just deal with the side effects.

Speaker 2

Wait, so I'm confused. So you're saying not as dangerous. So, and what a shame that women weren't allowed to use them earlier because there were these concerns and warnings on it.

Speaker 3

Right, So, what I'm saying is that the timing of the hormone replacement therapy that was tested in the w HI, the Women's Health Initiative study, was wrong. Timing of treatment is really critical. This is not just for hormones. For any kind of treatment, you cannot wait years when disease has truly evolved, where the physiological state is different, and then test the impact of your intervention. It's like having a treatment for Alzheimer's disease for the early.

Speaker 4

You know, most.

Speaker 3

Maybe even pre clinical stage of disease, but waiting until full blown dementia to test it. This is no different so doctor replacement.

Speaker 1

Yeah yeah, well so doctor Lowie. When should women start talking to their primary care physicians about hormone replacement therapy.

Speaker 3

Right around menopause? It's it's really really important, and this is really a point that I hope people here and start doing. When people are thinking that there may be perimenopausal that's when the conversation starts, or even before, as you're preparing to approach the age of which you may go through menopause or early post menopause.

Speaker 4

We don't actually know how many.

Speaker 3

Years can go by before you start hormone replacement therapy. We definitely know a decade is too much, and I would say as early as possible is probably the smartest move.

Speaker 2

Wait, so let me go back to because I do think it's safe to say, you know, as a woman like there has been that fear when it comes to hormone replacement therapy. So the concerns about cancer, heart disease, that's just not a reality.

Speaker 3

There is one kind of cancer that can the risk for which can increase.

Speaker 4

That's utter in cancer.

Speaker 3

If people are taking only estrogen, this is an important point. If women are considering to take only estrogen, they need to be aware that they need to get very close monitoring if they still have their uterus. But most hormon replacement therapy are of combination pills. The risk of heart disease. That was just because these were older women and the formulation that was used.

Speaker 4

The route would also matter.

Speaker 3

Oral estrogen therapy can increase the risk of coagulation and perhaps other things. So route of administration matters, Timing of administration really matters, and I would say that we are actually still in the dark with regards to the duration of the administration. That's a really important question remaining to be answered.

Speaker 2

So what should most women be asking themselves right now in regards to hormone replacement therapy.

Speaker 3

They need to be having the conversations with their providers and think about each The provider would need to be thinking about each woman on an individual level, their pros and cons to every treatment, and hormone replacement therapy in general no longer are considered risky and in fact, we think could be really beneficial.

Speaker 4

In the right clinical setting.

Speaker 3

If someone has a really high risk for various kinds of cancers, that would need to be taken into account, and the kind of hormone replacement therapy that is being administered would need to be investigated very closely. Women in general are at higher risk for various kinds of cancers, so the routine screening and care does not change the fact that getting hormone replacement therapy after menopause increases, independent of any other risk factors, your risk for breast cancer is no longer true.

Speaker 2

Interesting. I know we're not supposed to do this, but will you be my doctor?

Speaker 4

No, it's'll just be delighted.

Speaker 2

Okay, but I'm.

Speaker 4

A brain specialist. I will take care of your brain. Okay, really help with that.

Speaker 1

We only have about thirty seconds left. But I do want to know why you think hormone replacement therapy is having a moment right now after so many years of it being questioned by medical professionals.

Speaker 3

I'm really delighted because I think we believe that in an era of precision medicine, and this is one of the many changes that I hope to see implemented in healthcare where we design.

Speaker 4

The studies really well.

Speaker 3

But I hope that in the future we don't make conclusions on group levels anymore either, and that we have biomarker strategies. This is what my LIBE is really focused on, to make treatment precise for that given individuals, to decrease their risk and to maximize their benefit.

Speaker 2

Will you be all of art doctors so appreciate it. I already looking forward to next time. Doctor Fanny Alahi. She is Associate Professor of Neurology and your Science at the Icon School of Medicine at Mount Sinai, joining us right here in New York City.

Speaker 1

You got to make sure she accepts your insurance. I know you didn't check.

Speaker 2

This might be one you pay out a pocket for. I'm just saying, all right, this is Boomberg

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