The U.S. Food and Drug Administration is reviewing whether to change the warning label on hormone replacement therapy drugs used to treat menopause symptoms. File Photo by Jim Lo Scalzo/EPA
The U.S. Food and Drug Administration is reviewing whether to change the warning label on hormone replacement therapy drugs used to treat menopause symptoms, a move many experts say is long overdue.
"We are in serious discussions now about what to do about the black box warning, and I think you'll hear something on it very soon," FDA Commissioner Dr. Martin Makary said on CNN's Chasing Life podcast with Dr. Sanjay Gupta.
A black box warning is the FDA's most stringent for a prescription drug or medical device.
Since 2003, it has appeared on all estrogen menopause drugs. It warns of risks such as breast and uterine cancer, blood clots, stroke and dementia in women over 65.
