Oncologist Debunks Myth about Local Estrogen Concerns Ahead of FDA's Decision

The FDA is reviewing the black box warning currently placed on menopause treatments that contain estrogen.

This advisory has been in place for decades, suggesting that estrogen-based menopause treatments could increase the risk of strokes, blood clots, dementia, and breast cancer.

As a result, many women have been denied access to effective treatments for genitourinary syndrome of menopause (GSM), a condition that causes painful intercourse, frequent UTIs, and other debilitating symptoms.

However, the tide may be shifting. In July 2025, a panel of experts convened by the FDA urged the agency to reconsider the cautionary language on at least some forms of hormone therapy, which could pave the way for a reevaluation of treatments that have long been underused. One key focus: the safety of local vaginal estrogen.

A new perspective on local vaginal estrogen

Elizabeth Comen, MD, a leading oncologist and women’s health advocate, recently spoke to Tamsen Fadal for the journalist's podcast, The Tamsen Show. On the episode, she doubled-down on the efficacy and safety of local vaginal estrogen—often prescribed for women with GSM. Dr. Comen said it does not pose the same systemic risks associated with other forms of hormone therapy.

She explained that intra-vaginal estrogen is absorbed locally, affecting only the vaginal tissues and outer vulvar area, and has minimal to no systemic absorption that could impact other parts of the body.

This localized absorption has raised hopes that vaginal estrogen could be a safe and highly effective treatment for millions of women suffering from GSM, without triggering the serious risks associated with systemic estrogen.

The issue of estrogen use in patients with a history of cancer has been a point of concern in oncology. Topical estrogen products, especially those used for GSM, have been linked to debates about the potential risk of breast cancer recurrence.

However, Dr. Comen clarified that the local use of estrogen does not present the same systemic risks as oral or transdermal hormone therapies.

"Historically we have told [women] that they cannot use intra-vaginal estrogen, which we now know is safe. So there’s nothing that’s systemically absorbed by that or absorbed in any appreciable manner that would increase their risk of breast cancer," Dr. Comen said. "And yet we have many young women and older women who are really suffering from painful intercourse, repeated UTIs, and they’re not being offered intra-vaginal estrogen when we know this can dramatically help their symptoms."

The impact on menopause care

As the FDA weighs the removal of the black box warning on local vaginal estrogen, it’s critical for healthcare providers to stay informed about the latest research.

Consider intra-vaginal estrogen as a viable and safe option for women suffering from GSM. This treatment has the potential to provide significant relief for symptoms that impact daily life without the risks previously attributed to systemic estrogen therapies.