VIDEO: Is the FDA’s black box on estrogen too ‘alarming’?
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.
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