FDA Pulls Warning Labels From Hormone Replacement Therapies

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.

Episode Transcript

Speaker 1 (00:02):
Bloomberg Audio Studios, Podcasts, radio News. You're listening to Bloomberg
Business Week with Carol Masser and tim Stenoveek on Bloomberg Radio.

Speaker 2 (00:15):
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

(00:38):
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 (00:54):
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

(01:15):
just the warning or the changing warnings coming from the
federal government on this net a good thing.

Speaker 3 (01:22):
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

(01:43):
hormone replacement therapy due to the fear of the side
effects that were not indicated.

Speaker 4 (01:49):
But I think now we need to make.

Speaker 3 (01:51):
Up for the lost time and advance the science to
the point where we are more precise with our predictions.

Speaker 1 (02:00):
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 (02:13):
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 (02:29):
By then, it's too late.

Speaker 3 (02:32):
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 (02:49):
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 (03:01):
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

(03:23):
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 (03:35):
You know, most.

Speaker 3 (03:38):
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 (03:48):
Yeah yeah, well so doctor Lowie. When should women start
talking to their primary care physicians about hormone replacement therapy.

Speaker 3 (03:54):
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 (04:18):
We don't actually know how many.

Speaker 3 (04:20):
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 (04:31):
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 (04:48):
There is one kind of cancer that can the risk
for which can increase.

Speaker 4 (04:54):
That's utter in cancer.

Speaker 3 (04:55):
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

(05:18):
formulation that was used.

Speaker 4 (05:19):
The route would also matter.

Speaker 3 (05:22):
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

(05:46):
be answered.

Speaker 2 (05:46):
So what should most women be asking themselves right now
in regards to hormone replacement therapy.

Speaker 3 (05:53):
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

(06:16):
think could be really beneficial.

Speaker 4 (06:19):
In the right clinical setting.

Speaker 3 (06:21):
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

(06:42):
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 (06:56):
Interesting. I know we're not supposed to do this, but
will you be my doctor?

Speaker 4 (07:01):
No, it's'll just be delighted.

Speaker 2 (07:03):
Okay, but I'm.

Speaker 4 (07:05):
A brain specialist. I will take care of your brain. Okay,
really help with that.

Speaker 1 (07:09):
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 (07:20):
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 (07:30):
The studies really well.

Speaker 3 (07:32):
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 (07:49):
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 (08:03):
You got to make sure she accepts your insurance. I
know you didn't check.

Speaker 2 (08:07):
This might be one you pay out a pocket for.
I'm just saying, all right, this is Boomberg