FDA Pulls Warning Labels From Hormone Replacement Therapies

Summary

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Podcast Summary: Bloomberg Businessweek

Episode: FDA Pulls Warning Labels From Hormone Replacement Therapies
Date: November 13, 2025
Hosts: Carol Massar & Tim Stenovec
Guest: Dr. Fanny Elahi, Associate Professor of Neurology and Neuroscience, Icahn School of Medicine at Mount Sinai

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Episode Overview

This episode of Bloomberg Businessweek focuses on the FDA’s recent decision to remove strict warning labels (black box warnings) from hormone replacement therapy (HRT) products used to manage menopause symptoms. Hosts Carol Massar and Tim Stenovec discuss the implications of this change with Dr. Fanny Elahi, an expert in neurology and neuroscience, exploring what led to the original warnings, what the new evidence suggests, and what this means for women’s health moving forward.

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Key Discussion Points & Insights

Background and Context: The FDA’s Decision

• The Change: On Monday, the FDA announced the removal of black box warnings about cancer and heart disease risks from HRT products. (01:45–02:24)
• Significance: This reverses a position that influenced U.S. healthcare for over 20 years.

What Went Wrong with Earlier Warnings?

• Historical Concerns Tied to Flawed Studies
  • Dr. Elahi notes that "we lost two decades... many women did not get the chance to go on hormone replacement therapy due to the fear of side effects that were not indicated." (02:51)
  • She explains that the landmark Women’s Health Initiative (WHI) study that prompted the warnings had major design flaws: it started hormone therapy in women well past menopause (mid-60s), “by then it's too late. The physiology has drastically changed.” (03:44)
• Timing Matters: HRT is most effective when started around the onset of menopause, not many years after. (04:31)

Is HRT Safe? What Does the Evidence Now Say?

• Cancer and Heart Disease Risks:
  • Dr. Elahi clarifies that the only increased cancer risk is uterine cancer, and that only applies if estrogen is taken alone, without progesterone, and in women who still have a uterus. (06:18)
    • “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.” (06:21)
  • The risk for heart disease was observed only in older women starting therapy well after menopause, often with oral formulations. (06:34)
  • Route and timing of HRT matter for side effects; oral estrogen can increase risk of blood clots, for example. (06:41)
• Breast Cancer Risk: Dr. Elahi states, “getting hormone replacement therapy after menopause increases independent of any other risk factors your risk for breast cancer is no longer true.” (07:22)

Practical Advice for Women

• When to Consider HRT:
  • “Right around menopause...when people are thinking they may be perimenopausal, that's when the conversation starts. Or even before.” (05:24)
  • “We definitely know a decade is too much. And I would say as early as possible is probably the smartest move.” (05:56)
• What to Ask Your Doctor:
  • Every woman is different—individual risk factors, family history, and health status should guide the decision.
  • Regular screening and personalized discussions with healthcare providers are key. (07:16)
  • HRT in the right clinical setting is not only safe but could be highly beneficial.

The Broader Picture: Why Now?

• The Shift Toward Precision Medicine:
  • Dr. Elahi: “I’m really delighted because I think we live in an era of precision medicine... where we design the studies really well... we don’t make conclusions on group levels anymore.” (08:49)
  • She hopes for biomarker-driven, individualized treatments to maximize benefit and minimize risk.

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Notable Quotes & Memorable Moments

• On Lost Opportunity:

  • “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 side effects that were not indicated.”
    — Dr. Fanny Elahi (02:54)

• On Study Design Flaws:

  • “It's like having a treatment for Alzheimer's disease ... but waiting until full blown dementia to test it. This is no different.”
    — Dr. Fanny Elahi (04:31)

• Direct, Actionable Advice:

  • “Right around menopause... that's when the conversation starts.”
    — Dr. Fanny Elahi (05:24)

• Clarifying Cancer Risks:

  • “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 hormone replacement therapy are combination pills.”
    — Dr. Fanny Elahi (06:21)

• Future of HRT:

  • “I hope that in the future we don’t make conclusions on group levels anymore... to make treatment precise for that given individual.”
    — Dr. Fanny Elahi (08:53)

• Lighthearted Farewell:

  • Carol Massar: “I know we're not supposed to do this, but will you be my doctor?”
    Dr. Elahi: “I would be delighted. Okay. But I'm a brain specialist. I will take care of your brain.” (08:25–08:31)

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Timestamps for Important Segments

• [01:44] Women's Health Segment Introduction
• [02:24] FDA removes black box warnings — expert reaction
• [03:44] Historical basis for original warnings and study design flaws
• [04:31] Importance of proper timing for HRT
• [05:24] When to start the hormone replacement therapy conversation
• [06:18] Clarifying cancer and heart risks
• [07:16] What women should be asking about HRT now
• [08:49] The rise of precision medicine and what the future holds

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Conclusion

This episode of Bloomberg Businessweek demystifies the FDA’s decision to remove strict warning labels from hormone replacement therapies, debunks lingering myths about cancer and heart risks, and delivers invaluable context on why the warnings existed for so long. Dr. Fanny Elahi’s expertise underscores the importance of personalized, timely conversations with healthcare providers as women approach menopause—and highlights the broader trend toward precision medicine in women’s health care.

Listeners are left with clear, science-backed guidance: timing and individualization are key, and the era of blanket HRT fears is ending. For anyone affected by menopause or working in healthcare, this episode is both clarifying and empowering.

Transcript

[Carol Massar]

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[Carol Massar]

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[Carol Massar]

Bloomberg Audio Studios podcasts Radio news.

[Tim Stankavich]

You're listening to Bloomberg Business Week with.

[CMA Awards Announcer]

Carol Massar and Tim Stanvak on Bloomberg Radio.

[Carol Massar]

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.

[Tim Stankavich]

Dr. Fanny Lahy is Associate professor of Neurology and Neuroscience at the Icahn School of Medicine at Mount Sinai. 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 were 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 net A good thing.

[Dr. Fanny Elahi]

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. But I think now we need to make up for the lost time and advance the science to the point where we are more precise with our predictions.

[Tim Stankavich]

Why were those statements there in the first place? If we go back in history, you said we lost. It's unfortunate that we lost 20 years of treatment here. Why do those, those come around in, in health care in the US in the first place?

[Dr. Fanny Elahi]

It was unfortunately a flawed design. Hormone replacement therapy was started for women who had gone through menopause in their 50s and it wasn't until mid-60s that hormone replacement therapy was started. By then it's too late. The physiology has drastically changed. A decade has gone by and the impact of hormones, 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.

[Carol Massar]

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

[Dr. Fanny Elahi]

Right. So what I'm saying is that the timing of the hormone replacement therapy that was tested in the W H I, 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, most, maybe even preclinical stage of disease, but waiting until full blown dementia to test it. This is no different. Hormone replacement.

[Tim Stankavich]

Yeah.

[Carol Massar]

Well.

[Tim Stankavich]

So Dr. Elahi, when should women start talking to their primary care physicians about hormone replacement therapy?

[Dr. Fanny Elahi]

Right around menopause. It's really, really important and this is really a point that I hope people hear 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 at which you may go through menopause or early post menopause. We don't actually know how many 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.

[Carol Massar]

Wait, so let me go back to. Because I do think it's safe to say as a woman, 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.

[Dr. Fanny Elahi]

There is one kind of cancer that can. The risk for which can increase. That's uterine cancer. 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 hormone replacement therapy are combination pills. The risk of heart disease, that was just because these were older women and the formulation that was used. The route would also matter. 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. That's a really important question remaining to be answered.

[Carol Massar]

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

[Dr. Fanny Elahi]

They need to be having the conversations with their providers and think about each. The providers would need to be thinking about each. Women 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 in the right clinical setting. 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.

[Carol Massar]

Interesting. I know we're not supposed to do this, but will you be my doctor? No, it's.

[Dr. Fanny Elahi]

I would be delighted. Okay. But I'm a brain specialist. I will take care of your brain.

[Tim Stankavich]

Okay.

[Carol Massar]

I need help with that.

[Tim Stankavich]

We only have about 30 seconds left, but I do wanna know why you think hormone replacement therapy is having a moment right now after so many years of it being questioned by medical professionals.

[Dr. Fanny Elahi]

I'm really delighted because I think we live 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 the studies really well. But I hope that in the future we don't make conclusions on group levels anymore e that we have biomarker strategies. This is what my lab is really focused on, to make treatment precise for that given individuals to decrease their risk and to maximize their benefit.

[Carol Massar]

Will you be all of our doctors? So appreciate it already. Looking forward to next time. Dr. Fanny Elahi. She is associate professor of neurology and neuroscience at the Icahn School of Medicine at Mount Sinai, joining us right here in New York City.

[Tim Stankavich]

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

[Carol Massar]

This might be one you'd pay out of pocket for. I'm just saying. All right, this is Bloomberg.

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[Dr. Fanny Elahi]

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