Bloomberg Businessweek FDA Pulls Warning Labels From Hormone Replacement Therapies
Nov 13, 2025
Fanny Elahi, a physician-scientist and Associate Professor at the Icahn School of Medicine, dives into the FDA's decision to remove strict warnings on hormone replacement therapies. She highlights the implications for women's health as more women may be encouraged to consider these treatments during menopause. Elahi explains the flaws in previous studies around HRT risks, the importance of personalized discussions with healthcare providers, and how advancements in precision medicine are changing perceptions and acceptance of these therapies.
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Black Box Removal Is Long Overdue
- The FDA's removal of black box warnings may correct a long-standing overestimate of HRT risks.
- Dr. Fanny Elahi calls it overdue and says two decades were lost to unnecessary fear.
Timing Changed The WHI Outcome
- The original Women's Health Initiative trial tested HRT too late in women's lives, biasing results.
- Timing matters because physiology shifts after a decade, changing treatment effects.
Start HRT Conversations Early
- Talk with your clinician about HRT around perimenopause or early post-menopause rather than waiting years.
- Start conversations early because a decade's delay can make HRT less effective.
