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FDA Lifts 20-Year Black Box Warning on Hormone Therapy

11/19/2025

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Summary

Story summary

The U.S. Food and Drug Administration (FDA) announced on November 10, 2025 the removal of the Black Box warning from hormone therapy packaging.
The warning existed for more than 20 years due to cancer and cardiovascular disease concerns.
Experts say systemic hormone therapy is safe for most women because the warning rested on outdated research.
Critics say clear information on risks remains essential.

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Story summary

The U.S. Food and Drug Administration (FDA) announced on November 10, 2025 the removal of the Black Box warning from hormone therapy packaging.
The warning existed for more than 20 years due to cancer and cardiovascular disease concerns.
Experts say systemic hormone therapy is safe for most women because the warning rested on outdated research.
Critics say clear information on risks remains essential.