FDA Removes Black Box Warning from Hormone Therapy

FDA Removes Black Box Warning from Hormone-Based Menopause Drugs: A Major Shift in PolicyThe Food and Drug Administration (FDA) has announced a significant change to the labeling of hormone-based drugs used for menopause symptoms. After twenty-two years of carrying the FDAs most severe warning label, over twenty different pills, patches, and creams containing hormones like estrogen and progestin will no longer bear this warning. This decision marks a major shift in FDA policy, as newer studies suggest that hormone therapy has fewer risks when started before age sixty and within ten years of menopause symptoms. The move aims to allow for more personalized decisions between doctors and their patients, challenging outdated thinking and recommitting to evidence-based medicine. However, some doctors have raised concerns about the process leading to this decision, suggesting it was flawed. Despite this, the FDA Commissioner, Marty Makary, has been a strong advocate for the change, calling the current label outdated and unnecessary. The debate over the broader health benefits of hormone therapy continues, with some experts suggesting it could reduce risks for heart disease and Alzheimers. DNN | The Daily News Now! The world’s first global local news network. Every city. Every story. AI powered. Hosted on Acast. See acast.com/privacy for more information.