The FDA says HRT is safe. Is it?

A few years ago, I had a client named Mary who was in her early 60s. During our intake session, she said she’d been on hormone replacement therapy for 20 years because, as she put it, “I have no interest in hot flashes and want to keep my libido intact.”

I didn’t know a lot about HRT, but I was aware it had been linked to some serious health conditions. Mary said she felt great and planned to continue it indefinitely.

This week, the Food and Drug Administration (FDA) issued a near-complete reversal of its stance on HRT. Said administration Commissioner Marty Makary, "The FDA is taking action to remove the black box warnings from estrogen-related products. This is based on a robust review of the latest scientific evidence."

The Women’s Health Initiative (WHI), a large federally funded study, began in 1991 to assess HRT’s long-term health effects in postmenopausal women. In 2002, however, the study was stopped early due to increased risks of breast cancer, heart disease, stroke, and blood clots. Within two years, HRT use in the US dropped by more than 60%.

Re-analyses of the WHI’s results and follow-up studies suggested that age and timing impacted the health risks, stating that women under 60 or within 10 years of menopause onset had lower risks and often greater benefits from HRT.

The president of the American College of Obstetrics and Gynecology has stated that, "like all medications, systemic estrogen (pills, skin patch, cream) products are not without risk, and their use should be based on an individualized conversation between patients and their clinicians."

There are several health conditions where HRT is not advised, including a history of breast and endometrial cancers, blood clots, stroke or heart attack, and liver disease.

To the ladies reading this, what are your thoughts about the stance taken by the FDA? Is this reason to view HRT as a viable option, or will the findings from the Women’s Health Initiative guide your opinion?

You can learn more details about the FDA’s decision in this article from NPR:
https://www.npr.org/sections/shots-health-news/2025/11/10/nx-s1-5604283/...