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

Bill blocks Federal Reserve members' dual appointments

Bill blocks Federal Reserve members’ dual appointments

By Zachery SchmidtThe Center Square Federal Reserve board members would not be able to hold dual positions appointed by the president if U.S. Sen. Ruben Gallego’s new bill becomes law....
Lawmakers call for changes to cashless bail as Illinois faces federal funding loss

Lawmakers call for changes to cashless bail as Illinois faces federal funding loss

By Jim Talamonti | The Center SquareThe Center Square (The Center Square) – Statehouse Republicans are calling for reform of the Pretrial Fairness Act as Illinois faces the potential loss...

WATCH: House committee debates D.C. crime after Trump emergency order

By Sarah Roderick-FitchThe Center Square For the first time since President Donald Trump declared a crime emergency in Washington, D.C., district leaders squared off with congressional lawmakers regarding the government’s...
Illinois quick hits: Unemployment down; Rivian supplier gets tax incentives

Illinois quick hits: Unemployment down; Rivian supplier gets tax incentives

By The Center SquareThe Center Square Unemployment down The unemployment rate in Illinois has dropped to its lowest point since July 2023. The Illinois Department of Employment Security announced the...
Pritzker’s office ‘extremely troubled’ by photo with suspect ‘peacekeeper’

Pritzker’s office ‘extremely troubled’ by photo with suspect ‘peacekeeper’

By Greg Bishop | The Center SquareThe Center Square (The Center Square) – Officials from the governor’s office say they were “extremely troubled” to learn that a man that Gov....
Democrats' CR could cost up to $1.4 trillion, add millions to Obamacare plans

Democrats’ CR could cost up to $1.4 trillion, add millions to Obamacare plans

By Thérèse BoudreauxThe Center Square Democrats’ plan to prevent a government shutdown could cost the federal government up to $1.4 trillion and subsidize millions of new Obamacare recipients over the...
Treasury goes after fentanyl-producing Sinaloa Cartel faction

Treasury goes after fentanyl-producing Sinaloa Cartel faction

By Brett RowlandThe Center Square The Treasury's Office of Foreign Assets Control designated Sinaloa Cartel faction Los Mayos, along with the leader of the faction's armed wing on Thursday. The...
Pritzker touts quantum future, state senator urges caution for taxpayers

Pritzker touts quantum future, state senator urges caution for taxpayers

By Jim Talamonti | The Center SquareThe Center Square (The Center Square) – Gov. J.B. Pritzker is touting Illinois as a destination for quantum computing companies, but a state senator...
Supreme Court sets oral arguments in tariff case

Supreme Court sets oral arguments in tariff case

By Brett RowlandThe Center Square The Supreme Court said Thursday it will hear arguments Nov. 5. in a case critical to a wide swath of President Donald Trump's economic agenda....
Dems release funding counterproposal full of partisan policy riders

Dems release funding counterproposal full of partisan policy riders

By Thérèse BoudreauxThe Center Square As the government shutdown deadline looms, Democrats are splitting sharply with Republicans over what kind of funding stopgap Congress should approve. While Republicans have introduced...
Erika Kirk named CEO of Turning Point USA

Erika Kirk named CEO of Turning Point USA

By Andrew RiceThe Center Square Erika Kirk, Charlie Kirk's widow, has been named the chief executive officer and chair of the board at Turning Point USA. Charlie Kirk founded the...
Assembly leadership condemns violence, pleads for peaceful future

Assembly leadership condemns violence, pleads for peaceful future

By J.D. DavidsonThe Center Square A little more than a week after the assassination of conservative political activist Charlie Kirk and three months after a Minnesota lawmaker was killed in...
Another Ohio public entity scammed out of more than $400,000

Another Ohio public entity scammed out of more than $400,000

By J.D. DavidsonThe Center Square For the second time this week, Ohio Auditor Keith Faber released details of a public entity being scammed out of more than $400,000 in a...
WATCH: Pritzker on Kimmel suspension; SNAP error rate alarms; hemp regulations loom

WATCH: Pritzker on Kimmel suspension; SNAP error rate alarms; hemp regulations loom

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 shares Illinois Gov....
Temporary Rockford Courthouse fence sparks debate over security and costs

Temporary Rockford Courthouse fence sparks debate over security and costs

By Catrina Barker | The Center Square contributorThe Center Square (The Center Square) – A temporary fence surrounding the federal courthouse in downtown Rockford, Illinois is drawing sharp criticism and...