The Food and Drug Administration said Monday that it will reverse two decades of precedent by removing “black box” warnings on hormone replacement therapy products for menopause, with the intent of increasing access to products to relieve common symptoms.
The warnings of negative long-term health effects from such therapy will be removed, but not warnings of endometrial cancer for systemic estrogen-alone products. At an announcement at the Department of Health and Human Services headquarters in Washington, D.C., officials touted long-term health benefits of taking the treatment within 10 years of the onset of menopause.
The warning stemmed from a government-run clinical trial in 2003 that concluded hormone replacement therapy for menopause increased the risk of heart disease and breast cancer. Since then, doctors have cautioned patients to use the treatment sparingly. The FDA black box warning is the strictest one the agency issues.
