What to know about menopause hormone therapy after FDA removed warnings

While taken, systemic therapy can also prevent the rapid loss of bone density that typically accompanies menopause. Photo: Pexels

(Grace Abels/ PBS News) — What does it mean when a warning label is removed from a medication after two decades?

On Nov. 10, the U.S. Food and Drug Administration said it will ask companies to remove most “black box” safety warnings — used on medications to warn patients of serious health risks —  from hormone drugs commonly used to treat menopause symptoms. The change comes after years of advocacy from gynecologists, patients and professional medical organizations.

The FDA began requiring the warnings in 2003 after results from a large study raised concerns the medications could increase the risk of breast cancer, stroke and heart attack. Patients became hesitant to take the medications, and prescriptions decreased.

More recent scientific research has shown the medications to be much safer than previously believed, especially for women under 60. Some types of hormone therapy slightly increase a woman’s risk for certain health conditions, but the increased risk is small. (…)

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