FDA to remove ‘black box’ warnings on menopausal hormone therapies

(The Center Square) – The U.S. Food and Drug Administration is removing the “black box” warnings from hormone replacement therapy products for menopause, health administration officials announced Monday.

A larger crowd than usual gathered for the announcement at the Department of Health and Human Services Monday, with small

HHS Secretary Robert F. Kennedy Jr. and Food and Drugs Commissioner Marty Makary were joined by several female doctors and described the guidance change from the FDA as an “historic day for women” in the U.S.

“With few exceptions, there may be no other medication in the modern era that can improve the health outcomes of women on a population level than hormone replacement therapy,” Makary said.

After a study done by the Women’s Health Initiative, the FDA began requ