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

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.

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.

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)

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

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.