A big win for women’s health and one that’s personal for me
By Dr. Leslie Saltzman, Chief Product Officer at Ovia Health by Labcorp and Medical Discipline Director, Consumer Health at Labcorp
For too long, fear and misinformation have shaped how we care for women experiencing perimenopause and menopause. The result? Millions went without therapies that could have improved both their quality of life and long-term health.
I know this first-hand as a practicing physician and a woman who has benefited from hormone replacement therapy (HRT). I’ve been on estrogen since age 36, after having a prophylactic hysterectomy. Safe, effective HRT has been transformative for me, not just for symptom relief, but also for my long-term health and overall well-being.
The FDA’s recent removal of the black box warning from many estrogen-containing menopause therapies marks a turning point¹. Science, not stigma, can now guide care decisions related to menopause, and it’s been a long time coming. To understand the impact of this change, it’s helpful to look back at what started the fear in the first place.
The principal results of the Women’s Health Initiative (WHI) study, Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women, were published in 2002, causing widespread concern about HRT.
However, the study included women with an average age of 63—well past menopause—and used hormone formulations that are now largely outdated.² Since starting HRT later carries higher heart and stroke risks, the WHI results don’t fully reflect the benefits for women who begin therapy closer to menopause.
After the study was published, the effect was unmistakable. Women and providers avoided HRT altogether and worried about long term-effects, leaving millions without relief from menopausal symptoms and the associated health complications.
Twenty three years later, the recommendations are finally aligned with science and data. The updated labeling removes the black box warning and references to cardiovascular disease, breast cancer, and probable dementia for all estrogen therapies. In addition, the labeling has also been updated to reflect the safety differences between systemic and local administration.
Importantly, the updated labeling provides guidance for starting HRT in women under 60 or within 10 years of menopause who have moderate to severe vasomotor symptoms. This regulatory shift isn’t just about individual women—it also has significant implications for health plans, employers, and care teams.
This has incredible meaning and potential to improve:
- Clinical impact: Evidence-based HRT improves quality-of-life outcomes and addresses long-term health risks.
- Member experience: Reducing fear and stigma empowers women to make informed, personalized care choices.
- Cost and outcomes: Supporting appropriate HRT can help reduce complications and downstream healthcare costs.
- Strategic positioning: Plans and care teams that integrate up-to-date menopause guidance demonstrate leadership in women’s health and member-centered care.
At Ovia Health by Labcorp, we see the difference clarity and trusted guidance make. By combining personalized tools with evidence-based education, we can help members live healthier, more vibrant lives while improving engagement and outcomes.
This reversal is a monumental call to action that supports equitable access to HRT for the women who can benefit from it, and provide support grounded in facts, not fear.
References
- FDA. HHS advances women’s health, removes misleading FDA warnings on hormone replacement therapy. 2025. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy-1
- AMA Journal of Ethics. After the Women’s Health Initiative: Menopausal women and hormone therapy. 2005;7(11). https://journalofethics.ama-assn.org/article/after-womens-health-initiative-menopausal-women-and-hormone-therapy/2005-11