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

Report: average American to receive $3,752 tax cut in 2026 due to OBBBA

Report: average American to receive $3,752 tax cut in 2026 due to OBBBA

By Thérèse BoudreauxThe Center Square The White House is touting a new economic analysis that estimates taxpayers will see an average $3,752 tax cut in 2026, due to provisions in...
Republican, Dem work to prevent deportation of entrepreneur

Republican, Dem work to prevent deportation of entrepreneur

By Chris WoodwardThe Center Square It is not every day that people on opposite sides of the political spectrum join forces, but that is exactly what Lisa Everett and Brent...
Nevada superintendent says ICE won't enter schools

Nevada superintendent says ICE won’t enter schools

By Liam HibbertThe Center Square The superintendent of the nation's fifth-biggest school district said U.S. Immigration and Customs Enforcement agreed to not conduct raids or arrests in schools in Las...
MAHA-style bill would close food additive safety loophole

MAHA-style bill would close food additive safety loophole

By Thérèse BoudreauxThe Center Square With deregulation-focused Republicans in Congress reluctant to fulfill the industry-wary goals of the Make America Healthy Again initiative, some Democrats are taking up the torch....
Legislators criticize Illinois’ utility policies as ‘unsustainable’

Legislators criticize Illinois’ utility policies as ‘unsustainable’

By Greg Bishop | The Center SquareThe Center Square (The Center Square) – Gov. J.B. Pritzker’s law banning utility shutoffs during extreme heat and cold is sparking concerns over rising...
John-Wofford-1755084241

John William Wofford, 55

John William Wofford, 55, of Charleston, Illinois, formerly of Casey, Illinois, passed away unexpectedly on Friday, August 8, 2025, at 8:50 p.m. in rural Westfield, Illinois. He was born January...
D.C. attorney general sues Trump administration, claiming 'unlawful' takeover

D.C. attorney general sues Trump administration, claiming ‘unlawful’ takeover

By Sarah Roderick-FitchThe Center Square Days after President Donald Trump declared “Liberation Day” by federalizing the Washington, D.C. Metropolitan Police Department and deploying hundreds of National Guard members to curb...
What’s on the table for Trump’s meeting with Putin?

What’s on the table for Trump’s meeting with Putin?

By Caroline BodaThe Center Square President Donald Trump is flying to Alaska on Friday for a high-stakes meeting with Russian President Vladimir Putin to discuss terms for a ceasefire in...
WATCH: Illinois In Focus Daily | Friday Aug. 15th, 2025

WATCH: Illinois In Focus Daily | Friday Aug. 15th, 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 talks with gun...
Federal government to drop 300,000 workers this year

Federal government to drop 300,000 workers this year

By Brett RowlandThe Center Square The federal government is on pace to eliminate about 300,000 workers this year. Office of Personnel Management director Scott Kupor said 80% of those employees...
Illinois quick hits: Ex-student sentenced for school gun, time served; fall semester beginning

Illinois quick hits: Ex-student sentenced for school gun, time served; fall semester beginning

By Jim Talamonti | The Center SquareThe Center Square Ex-student sentenced for school gun, time served A former Chicago Public Schools student has been sentenced to five years in prison...
Casey illinois library.1.logo graphic

Casey Library Board Moves Funds for Expenses Amid $12,000 Air Conditioner Repair Quote

Casey Township Library Board of Trustees Meeting | June 26, 2025 Article Summary: The Casey Township Library Board of Trustees is seeking additional quotes for a critical air conditioner repair...
Grand jury indicts accused killer of Minnesota lawmaker

Grand jury indicts accused killer of Minnesota lawmaker

By J.D. DavidsonThe Center Square The man accused of killing Minnesota’s former House speaker and her husband faces state charges of first-degree murder. Hennepin County Attorney Mary Moriarty said Thursday...
Sailors return to San Diego after extended Navy deployment

Sailors return to San Diego after extended Navy deployment

By Jamie ParsonsThe Center Square After spending almost nine months overseas, the USS Carl Vinson and Carrier Strike Group One returned to Naval Base San Diego on Thursday afternoon, with...
Under pressure, RFK Jr. brings back childhood vaccine safety committee

Under pressure, RFK Jr. brings back childhood vaccine safety committee

By Brett RowlandThe Center Square U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. announced Thursday the reinstatement of the Task Force on Safer Childhood Vaccines, the day...