For more than twenty years, hormone therapy for menopausal symptoms, including estrogen-based formulations such as pills, patches, and creams, carried a “black box warning,” the strongest caution that the US Food and Drug Administration (FDA) can impose on a drug label. This warning prominently alerted patients and clinicians to potential risks such as heart disease, stroke, breast cancer, and dementia.
The black box warning was introduced in 2003 following the Women’s Health Initiative study, which, at the time, suggested a correlation between hormone therapy and an array of serious health conditions. However, later analyses indicated that these findings might not have applied to most women using hormone therapy as prescribed. This realization emerged largely because the participants enrolled in the Women’s Health Initiative studies were significantly older, with an average age of 63, and many were already well past menopause when their treatment began.
Conversely, subsequent observational studies have suggested that women who initiate hormone therapy at a younger age, typically under 60, may experience lower risks compared to those who begin treatment later. However, these findings are not universally supported, and the interplay between age, timing of treatment, and long-term outcomes remains a subject of ongoing investigation.
This week, the FDA announced that it will remove the black box warning from menopause-related hormone therapies. According to a report published by CNN and comments made by experts interviewed for the piece, the agency’s decision reflects the acknowledgment that the 2003 caution may have been overly broad and may have discouraged both women and healthcare providers from considering potentially effective treatment options.
Some clinicians have welcomed the move as a long-overdue correction to a decades-old stigma. In contrast, others urge prudence, emphasizing that political and cultural factors can also shape how medical risks are framed in the United States.
Whether the removal of the black box warning will ultimately prove to be a wise choice remains to be seen. What is clear, however, is that this decision represents a turning point in how menopausal hormone therapy is perceived and managed, one that highlights the importance of individualized care and a deeper, evidence-based understanding of its risks and benefits.
