The U.S. Food and Drug Administration will remove the "black box" warning labels on many hormone therapy drugs used for menopause and perimenopause symptoms — a major turnaround that's likely to encourage more women to seek treatment. FDA Commissioner Dr. Marty Makary said in an exclusive CBS News interview that the change ends a decades-long "fear machine," and he called the demonization of menopause hormone therapy, also known as hormone replacement therapy (HRT), "an American tragedy."
"With the exception of vaccines or antibiotics, there's no medication that can improve the health of women on a population level more than hormone replacement therapy," Makary told senior correspondent Norah O'Donnell, explaining that studies show that menopause hormone therapy can reduce the risk of heart attacks, the leading cause of death in women.
The products affected by this change include medicines containing both estrogen and progesterone, systemic estrogen and topical estrogen.
The "black box" warning labels were based on what many experts now consider flawed research on HRT from more than 20 years ago. Part of the criticism is that back in 2002, researchers on the Women's Health Initiative study overstated the risks of breast cancer because the data focused on older women.
More recent studies have shown the benefits outweigh the risk for many women if hormone therapy is used in the early years of menopause, before the age of 60.
"We now have a more nuanced understanding, and we want to put that fear machine in its proper context and let people know that there are tremendous long-term health benefits," Makary said.
