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

Spread the love

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.

Leave a Comment





Latest News Stories

Abbott to call 'special session after special session' in response to AWOL Dems

Abbott to call ‘special session after special session’ in response to AWOL Dems

By Bethany BlankleyThe Center Square Gov. Greg Abbott confirmed what many in Austin speculated: he will call special session after special session until bills are passed. Abbott called the current...
WATCH: Illinois In Focus Daily | Friday Aug. 8th, 2025

WATCH: Illinois In Focus Daily | Friday Aug. 8th, 2025

By Greg Bishop | The Center SquareThe Center Square (The Center Square) – In today's edition of Illinois in Focus Daily, The Center Square Editor Greg Bishop covers the latest...
Legislator urges leaders to focus on relief for Illinois’ high property taxes

Legislator urges leaders to focus on relief for Illinois’ high property taxes

By Glenn Minnis | The Center Square contributorThe Center Square (The Center Square) – With Illinois now being home to the highest property tax rates in the country, state Rep....
Charles-Harlan-1754588106

Charles Dewain Harlan, 73

Charles Dewain Harlan, 73, of Mt. Vernon, Illinois, formerly of Greenup, Illinois, passed away at 5:25 p.m. on Wednesday, August 6, 2025, at Greentree Assisted Living in Mt. Vernon. He...
Meeting Briefs

Meeting Briefs: Casey City Council for August 4, 2025

The Casey City Council met Monday to approve its annual spending plan, address blighted properties, and discuss impending utility rate increases driven by inflation and a shrinking customer base. The...
Texas House, Illinois state senator sue 33 AWOL Democrats in Illinois court

Texas House, Illinois state senator sue 33 AWOL Democrats in Illinois court

By Bethany Blankley | The Center Square contributorThe Center Square (The Center Square) – The Texas House of Representatives has sued 33 House Democrats who absconded to Illinois to prevent...
WATCH: Democrat state redistricting efforts created unfair advantages, lawmaker says

WATCH: Democrat state redistricting efforts created unfair advantages, lawmaker says

By Bethany Blankley | The Center Square contributorThe Center Square (The Center Square) – While Democratic lawmakers from California to New York have threatened to redistrict in response to Texas'...
Illinois quick hits: Fatal helicopter crash; Comptroller orders another extra pension payment

Illinois quick hits: Fatal helicopter crash; Comptroller orders another extra pension payment

By Jim Talamonti | The Center SquareThe Center Square Fatal helicopter crash Two people are dead after a helicopter crashed into a barge on the Mississippi River. The Federal Aviation...
New poll: 50.2% of Illinois voters view Pritzker unfavorably

New poll: 50.2% of Illinois voters view Pritzker unfavorably

By Jim Talamonti | The Center SquareThe Center Square (The Center Square) – A new poll shows that Gov. J.B. Pritzker’s approval rating has flipped negative for the first time....
WATCH: Pritzker welcomes FBI looking for TX Dems in IL, dismisses bribery question

WATCH: Pritzker welcomes FBI looking for TX Dems in IL, dismisses bribery question

By Greg Bishop | The Center SquareThe Center Square (The Center Square) – As the FBI gets involved in locating Texas Democrats hiding out in states like Illinois, Gov. J.B....
WATCH: Illinois State Fair: Affordable fun backed by $140M in taxpayer funding

WATCH: Illinois State Fair: Affordable fun backed by $140M in taxpayer funding

By Catrina Barker | The Center Square contributorThe Center Square (The Center Square) – The 2025 Illinois State Fair is being praised for its affordability and accessibility to families across...
Op-Ed: State lawmakers gut Emmett Till Day bill, expose Illinois’ corruption problem

Op-Ed: State lawmakers gut Emmett Till Day bill, expose Illinois’ corruption problem

By LyLena D. Estabine | Illinois Policy InstituteThe Center Square July 25, 2025, would have marked Illinois’ first Emmett Till Day, a commemoration of the 14-year-old Chicagoan whose 1955 lynching...
Democratic PACs being investigated for bankrolling AWOL Texas House Democrats

Democratic PACs being investigated for bankrolling AWOL Texas House Democrats

By Bethany Blankley | The Center Square contributorThe Center Square (The Center Square) – Democratic political action committees are being investigated by state, and potentially federal, authorities over claims they...
Pritzker: Chicago mayor 'never once called' to oppose pension bill

Pritzker: Chicago mayor ‘never once called’ to oppose pension bill

By Jim Talamonti | The Center SquareThe Center Square (The Center Square) – Illinois Gov. J.B. Pritzker says Chicago Mayor Brandon Johnson never called him to oppose a pension bill...
WATCH: Illinois In Focus Daily | Thursday Aug. 7th, 2025

WATCH: Illinois In Focus Daily | Thursday Aug. 7th, 2025

By Greg Bishop | The Center SquareThe Center Square (The Center Square) – In today's edition of Illinois in Focus Daily, The Center Square Editor Greg Bishop continues his coverage...