(NewsNation) — The head of the U.S. Food and Drug Administration signaled Thursday that he supports changing or removing the warnings printed on hormone replacement therapy products for menopausal women because the caution labels overstate the health risks.
FDA Commissioner Marty Makary, whose agency convened a panel of experts earlier in the day to discuss the topic, told “Elizabeth Vargas Reports” that so-called “black box” warnings have discouraged many women from undergoing a therapy that offers several health benefits. He said the information about the potential adverse effects of HRT, such as breast cancer, is a “remnant dogma” inconsistent with medical evidence.
“There is an enlightenment in the medical field that this may have been one of the greatest mistakes of modern medicine in the last 25 years,” Makary said.
For years, menopause treatments with estrogen have carried the black box, but HRT supporters say the therapy alleviates debilitating symptoms of menopause and reduces the long-term risk of osteoporosis and fatal heart attacks.
Makary said women on HRT generally have better health outcomes, although there are rare circumstances in which individuals should not be prescribed the products. He noted most medical experts recommend women begin HRT within 10 years of the onset of menopause to realize the long-term health benefits.
“We haven’t been able to see the forest from the trees when talking about the risks and benefits of HRT. People deserve to know the facts,” Makary said.
The New York Times reported that Makary selected Thursday’s panelists, who consistently pushed back at the current warning labels. One member of the audience pressed the FDA commissioner to take public comment, but Makary said he wanted to move quickly on a decision.