The FDA will lift warnings on hormone therapy for menopause

Published: Monday, November 10, 2025 at 4:05 pm

FDA to Remove Black Box Warnings on Menopause Hormone Therapy

The Food and Drug Administration (FDA) is set to remove the black box safety warnings from all hormone therapy treatments prescribed to alleviate symptoms of menopause and perimenopause. These warnings, prominently displayed on creams, pills, and other treatments, previously cautioned about potential risks of certain cancers, dementia, heart attacks, and strokes.

According to FDA Commissioner Marty Makary, the warnings had a chilling effect, deterring women from utilizing treatments that could, in fact, improve their health. The FDA's decision follows a reevaluation of the available scientific evidence. The agency convened an expert panel in July to discuss the removal of warnings, initially focusing on low-dose vaginal estrogen. The FDA also opened a public docket, receiving nearly 3,000 comments by the September 24 deadline.

The American College of Obstetrics and Gynecology (ACOG) has long advocated for a reevaluation of warning labels on low-dose estrogen products administered vaginally. However, ACOG distinguishes these from systemic estrogen products, such as pills and patches, that deliver the hormone throughout the body.

The decision comes after years of debate among doctors regarding the risks and benefits of hormone replacement therapy. A 2002 study, the Women's Health Initiative, initially raised concerns about increased risks of cancer and stroke. Subsequent research has suggested that these risks were overstated, and that the therapy can reduce heart disease when prescribed earlier.

While doctors generally support the removal of the warnings, ACOG has expressed concerns about the process the FDA used. ACOG believes the expert panel deviated from the usual process for making such changes and lacked the rigor of the standard advisory committee meetings. These committees, composed of independent experts, evaluate scientific evidence and provide recommendations to the FDA. ACOG urges the FDA to delve deeper into the benefits of low-dose vaginal estrogen and systemic estrogen therapy by convening separate advisory committee meetings.

The FDA cited several studies supporting its decision, including research showing that hormone therapies can reduce the risk of Alzheimer's disease, heart attack, and hip fracture. The agency also referenced an analysis of 30 studies, published in 2004, which indicated that starting hormone replacement therapy earlier could save lives.

BNN's Perspective:

The FDA's decision to remove the black box warnings is a welcome step, potentially allowing more women to access treatments that could improve their health. However, the concerns raised by ACOG regarding the process are valid. While the FDA's ultimate goal is to provide the best care for patients, it is important to ensure that the process is transparent and that all perspectives are considered. A more thorough review, including the use of advisory committees, would have provided greater confidence in the decision.

Keywords: FDA, hormone therapy, menopause, black box warnings, estrogen, ACOG, health risks, cancer, dementia, heart attack, stroke, Women's Health Initiative, Alzheimer's disease, perimenopause, treatment, safety, risks, benefits

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