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Menopause advocates and providers urge FDA to change how it labels vaginal estrogen for GSM

Let’s Talk Menopause has launched the Unboxing Menopause campaign to remove the outdated and misleading FDA boxed warning on local vaginal estrogen, a treatment essential for addressing Genitourinary Syndrome of Menopause (GSM).
Let's Talk Menopause
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Christopher Gillispie
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Let’s Talk Menopause has launched the Unboxing Menopause campaign to remove the outdated and misleading FDA boxed warning on local vaginal estrogen, a treatment essential for addressing Genitourinary Syndrome of Menopause (GSM).
Coverage of aging is supported in part by AARP Arizona

A national nonprofit that empowers individuals to talk about menopause has launched a campaign to remove what it calls “outdated and misleading” FDA warnings on vaginal estrogen, which is used to treat a very common condition in postmenopausal women.

Tamsen Fadal is a filmmaker, author and menopause advocate. She also sits on the board of Let’s Talk Menopause, which recently launched the Unboxing Menopause campaign.

Fadal says vaginal estrogen is a highly effective treatment for genitourinary syndrome of menopause, or GSM.

"It's a chronic, progressive condition ... that includes urinary leakage, more and more UTIs, vaginal dryness, like I mentioned, burning, itchiness and then of course, painful sex," Fadal said.

Tamsen Fadal wrote a new book called "How to Menopause." Hear her read an excerpt.

And it's common. "Listen, it affects 84% of women post menopausal, meaning, the rest of their lives they experience these symptoms," Fadal said.

Dr. Jewel Kling is the chair of the Division of Women's Health Internal Medicine at Mayo Clinic.

"Low-dose vaginal estrogen does not carry the same risks as systemic hormone therapy, so the labeling on the product should be different," Kling said.

Kling says she sees many patients who refuse to use low-dose vaginal estrogen because they’re worried it might lead to a heart attack, a blood clot, breast cancer or even dementia.

"We have lots of research that shows that it does not cause those things," she said.

And she supports changing the label to something more appropriate.

"Sometimes women don't realize that that may be a menopause symptom, but it's really common, and it can be debilitating to some women, vaginal dryness, pain with intercourse, and it can increase their risk of urinary tract infections or cause symptoms like urinary urgency," she said.

She says since we have a safe and effective way to treat GSM, women should be empowered to use it.

KJZZ senior field correspondent Kathy Ritchie has 20 years of experience reporting and writing stories for national and local media outlets — nearly a decade of it has been spent in public media.
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