FDA to remove safety warnings on hormonal menopause therapy

The Food and Drug Administration plans to discard warning labels for hormone therapies for menopausal women, undoing decades-old language cautioning that treatments may increase the risk of cancer or heart disease.

In a statement Monday, the FDA said it is initiating the removal of “boxed” warnings for all hormone replacement therapies, or HRTs. That announcement was issued alongside a press conference from the U.S. Department of Health and Human Services as well as an op-ed FDA Commissioner Martin Makary published in the Wall Street Journal. The decision was issued following a “comprehensive review of the scientific literature,” feedback from an expert panel in July , and a public comment period, the agency said.

“Millions of women were told to fear the very therapy that could hav