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

By Morgan Sweeney
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 clusters of women wearing wide smiles posing for pictures in front of the stage beforehand. The occasional woman in a white lab coat could be seen in the audience.

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 requiring warnings on menopausal hormone therapies in 2003 linking them to higher chances of breast cancer, heart attack, blood clotting and stroke.

But Kennedy and Makary said that the data from the study was misinterpreted and that hormone therapy for older women can have serious health benefits besides just lessening the symptoms of menopause, including greater longevity.

“There are now recognized to be profound long-term health benefits that few people, even physicians, know about,” Makary said, pointing to studies that have shown a 50% to 60% reduction in bone fractures and a 30% to 50% reduction in coronary heart disease. Heart disease is the leading cause of death of both men and women.

Makary didn’t dwell on the potential benefits of hormone therapy when it comes to Alzheimer’s Disease. He noted that one study had suggested it could reduce the risk of the illness, but another doctor spoke about how hormone therapy can positively impact the brain.

“A preponderance of data now shows that estrogen, when started early, acts as a protective shield for the brain, lowering your symmetry loss, mental health, decline and neurodegenerative disease, even Alzheimer’s,” said Alicia Jackson, the Advanced Research Projects Agency for Health director. “It improves metabolic and immune function [and] reduces cardiovascular disease, diabetes and fracture risk.”

“Estrogen is one of the most effective longevity interventions for women,” she added.

Makary and others said that women’s health has not historically received the attention it deserves from the male-dominated physician community, and that the guidance against hormone therapy is an example of the non-scientific “medical group think” that enabled falsities like “opioids aren’t addictive” and “saturated fats are bad for you” to flourish.

“We’re going to stop the fear regime steering women away from this life-changing, life-saving treatment,” Makary said.