This week, the US Food and Drug Administration (FDA) announced the removal of class-wide boxed warnings related to risks of cardiovascular disease, breast cancer, and dementia—retaining only the warning for endometrial cancer with unopposed estrogen—from all menopausal hormone therapy products. These risks were established in 2002 and directly based on data from the Women’s Health Initiative (WHI) randomized clinical trials.
NBCC recognizes that there may be appropriate circumstances in which newer, lower-dose, or transdermal hormone formulations provide meaningful symptom relief for women near the onset of menopause and may carry different risk profiles. However, such conclusions must be supported by robust, prospective clinical research.
NBCC believes that changes to FDA warnings and labeling should be grounded in rigorous, contemporary evidence—not post-hoc or subgroup re-analyses of older trials such as the WHI.
NBCC is also concerned about the process used by the FDA to make this determination. The decision followed only a brief, two-hour “expert panel” meeting rather than a full advisory committee process, which would have allowed for independent scientific review and meaningful public engagement.
Such abbreviated procedures fall short of the transparency and rigor expected for decisions that affect the health and trust of millions of women. Maintaining public confidence in science and regulatory oversight requires open, evidence-based processes that invite diverse expertise and stakeholder input before significant policy changes are made.
