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Is the FDA’s Black Box on Estrogen Too ‘Alarming’?

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NATIONAL HARBOR, MD. – Does the Food and Drug Administration’s black-box warning on estrogen contribute to noncompliance – or worse, to clinicians being unwilling to prescribe estrogen treatments – leaving many women to suffer untreated menopause symptoms?

The leadership of the North American Menopause Society thinks so, and the organization has started a campaign to get the FDA to reconsider how it labels estrogen.

“We would like the label for low-dose, vaginal estrogen to better reflect the true safety and risk profile,” said Dr. JoAnn Manson, chair of this year’s NAMS scientific committee.

In a video interview, Dr. Manson discusses how the current black-box labeling may impede effective treatment, and why revised, more-nuanced estrogen labeling could improve outcomes for many women.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel.

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