FDA Hormone Therapy Warnings Lifted: Skepticism and the Road Ahead
The Food and Drug Administration (FDA) is removing black box safety warnings from hormone therapy treatments for menopause, citing a review of recent scientific evidence. The warnings, which previously highlighted risks of cancer, dementia, heart attacks, and strokes, will be removed to increase accessibility and facilitate shared decision-making between patients and clinicians. Despite this change, systemic estrogen products still carry potential risks, and the American College of Obstetrics and Gynecology (ACOG) emphasizes the importance of individual consultations. The FDA’s decision, however, has drawn some criticism, as it bypassed the usual advisory committee process.
John Q. Hosedrinker