According to reports, the U.S. Food and Drug Administration is reconsidering the “black-box” warnings attached to hormone therapy for menopause. These warnings alert patients to serious risks such as stroke, blood clots, dementia, and breast cancer. New research and expert opinions suggest some of these risks might be overstated under certain conditions.
Many women use hormone therapy such as estrogen via patches, pills, gels, sprays, or vaginal devices to relieve common menopause symptoms like hot flashes, night sweats, and sleep disturbances. However, the black-box warnings, which have been standard for years, have made many women wary of these treatments.
Some doctors now believe earlier studies especially the large Women’s Health Initiative study from 2002 gave an exaggerated picture of certain risks because they focused on older women who started hormone therapy long after menopause had already begun.
According to these experts, factors such as how old a woman is when she starts treatment, how strong the dose is, and what form the therapy takes (for example topical vs systemic) greatly influence safety.
Dr. Mary Rosser of Columbia University emphasized that beginning treatment closer to the last menstrual period and continuing until around age 60 may reduce risks. She says doctors and patients should work together to weigh each woman’s personal history and risk factors including family history of breast cancer before deciding on hormone therapy.
The FDA has assembled a panel to review the evidence. Some versions of hormone therapy may have warnings relaxed if safer use is shown. Yet many medical researchers are urging caution. A group of 76 doctors and scientists recently asked the agency to hold open hearings and further advisory committee meetings before making any changes.
For women like 53-years-old Isabel Kallman, treatment decisions are difficult. She experiences typical menopause symptoms, but worries about risks due to the labels on hormone therapy. She hopes for clearer guidance and options that balance relief with safety.
