FDA Reconsiders Black Box Warning on Hormone Therapy

Hormone therapy has faced a tumultuous history since a 2002 clinical trial linked it to increased heart attacks and strokes. However, research has debunked these findings, showing that hormone therapy is safe for most healthy women in menopause.

A recent FDA panel discussion, led by Commissioner Marty Makary, MD, aimed to “set the record straight” about hormone therapy’s use in easing menopause symptoms. The panel highlighted the positive effects of hormone therapy, particularly for vaginal estrogen, which is used to alleviate painful sex and urinary tract infections.

Experts argue that the black box warning label on vaginal estrogen is misleading, as it’s based on systemic estrogen products with a higher risk of blood clots and strokes. Vaginal estrogen, applied locally, does not carry this risk. The label has kept women from using vaginal estrogen, which could worsen bladder issues and increase the risk of infections.

Panel members, including Dr. Mary Jane Minkin, MD, and Dr. Lauren Streicher, MD, advocate for removing the black box warning on vaginal estrogen. They argue that the risks associated with hormone therapy are minimal and do not outweigh its benefits.

While a decision has not been made yet, Commissioner Makary’s comments suggest that the FDA is moving towards revising or removing the label. The Unboxing Menopause Campaign offers resources for those interested in learning more about this issue.

Source: https://www.womenshealthmag.com/health/a65437644/estrogen-black-box-warning-fda