The U.S. Food and Drug Administration (FDA) has announced the removal of black box safety warnings from all hormone therapy products used to manage symptoms of menopause and perimenopause. This decision applies to creams, pills, and other treatments.
These prominent warnings previously indicated a potential increase in risks for certain cancers, dementia, heart attacks, and strokes. FDA Commissioner Marty Makary stated that these warnings had created apprehension among women regarding therapies that could offer health benefits. Makary emphasized a more nuanced understanding of these treatments and noted potential long-term health advantages.
FDA's Process and Expert Input
The FDA initiated this reevaluation by convening an expert panel in July to specifically discuss the removal of warnings from low-dose vaginal estrogen. Following this, the agency opened a public docket for comments, receiving nearly 3,000 submissions by the September 24 deadline.
The American College of Obstetricians and Gynecologists (ACOG) submitted formal comments. ACOG stated it has consistently supported the reevaluation of warning labels for low-dose vaginal estrogen products. However, ACOG differentiates these from systemic estrogen products, such as pills and patches, which deliver hormones throughout the body.
Historical Context and Medical Perspectives
Discussions regarding the risks and benefits of hormone replacement therapy have evolved over time within the medical community. In 2002, the Women's Health Initiative (WHI) study indicated an association between hormone therapy and increased risks of cancer and stroke, leading to widespread concern. Subsequent research has suggested that some of these risks were initially overstated and that early prescription of therapy may reduce heart disease risk.
Despite general medical support for the removal of black box warnings, ACOG expressed concerns about the FDA's procedural approach for this specific change. ACOG stated that the two-hour expert panel held on July 17 should not be considered an adequate replacement for a comprehensive advisory committee meeting.
ACOG highlighted that FDA advisory committees typically consist of independent experts who evaluate scientific presentations, debate evidence, and then vote on recommendations for the agency. While the FDA is not bound to follow these recommendations, it generally does. ACOG commented that bypassing the advisory committee process conflicts with the agency's stated goal of increasing transparency. Consequently, ACOG urged the FDA to conduct separate advisory committee meetings, including public engagement opportunities, to further investigate the benefits of low-dose vaginal estrogen for genitourinary syndrome of menopause (GSM) and systemic estrogen therapy for vasomotor symptoms, prior to making final labeling decisions for these distinct menopausal hormone therapy options.