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

Trump says he won't back down on Antifa terrorism designation

Trump says he won’t back down on Antifa terrorism designation

By Brett RowlandThe Center Square President Donald Trump is moving quickly against an organization that he blames for destruction, looting and protests, another indication the president is acting faster during...
Exclusive: DOJ 'weaponization' victim still in jail, asking for Trump pardon

Exclusive: DOJ ‘weaponization’ victim still in jail, asking for Trump pardon

By Bethany BlankleyThe Center Square After former FBI Director James Comey was indicted on Thursday and as Congress continues to investigate the “weaponization” of the Biden Department of Justice, one...
Champaign stabbing raises concerns over Illinois mental-health law

Champaign stabbing raises concerns over Illinois mental-health law

By Catrina Barker | The Center Square contributorThe Center Square (The Center Square) – A state lawmaker who also serves as a police officer says the recent stabbing of non-police...
lake land college.2

Lake Land College Invests Over $360,000 in Allied Health Program Technology

Article Summary: The Lake Land College Board of Trustees approved a series of major purchases totaling more than $360,000 to enhance the college’s Allied Health and nursing programs. The investments...
Colorado tops nation for millennial migration, report finds

Colorado tops nation for millennial migration, report finds

By Elyse ApelThe Center Square Millennials are flocking to Colorado, according to a recent report that looked at migration rates nationwide. In 2024, nearly one in every 10 millennials in...
Congress unmoved by imminent government shutdown threat

Congress unmoved by imminent government shutdown threat

By Thérèse BoudreauxThe Center Square Only four days remain until the federal government runs out of money and partially shuts down, but Republican and Democratic leaders in Congress refuse to...
Illinois quick hits: DHS apprehends ICE protester with firearm; bill allows campaign funds for security

Illinois quick hits: DHS apprehends ICE protester with firearm; bill allows campaign funds for security

By Jim Talamonti | The Center SquareThe Center Square DHS apprehends ICE protester with firearm The U.S. Department of Homeland Security says more than 200 rioters blocked access to a...

Exclusive: BlackRock pressured ‘woke’ ideology on companies

By Andrew RiceThe Center Square The nonprofit Consumers’ Research urged the Department of Justice and the Federal Trade Commission to conduct tougher enforcement efforts on investment firms like BlackRock in...
Trump's tariffs on imported drugs could raise prices

Trump’s tariffs on imported drugs could raise prices

By Brett RowlandThe Center Square Analysts are warning that U.S. consumers could face higher prices after President Donald Trump promised it will hit imported drugs with a 100% tariff next...
Lawmaker responds to IL’s push for adult COVID shots against CDC guidance

Lawmaker responds to IL’s push for adult COVID shots against CDC guidance

By Catrina Barker | The Center Square contributorThe Center Square (The Center Square) – Illinois health officials recommend all adults get the COVID-19 vaccine this fall, defying recent U.S. Centers...
Immigration advocates sue Trump administration over 'unlawful' ICE arrests

Immigration advocates sue Trump administration over ‘unlawful’ ICE arrests

By Andrew RiceThe Center Square A coalition of immigrants rights advocacy organizations filed a lawsuit against the Trump administration over its immigration enforcement in Washington, D.C. The advocacy organizations, which...
18% of med schools receive F when judged by academic excellence, DEI rejection

18% of med schools receive F when judged by academic excellence, DEI rejection

By Tate MillerThe Center Square Of 154 medical schools analyzed, 28 received a grade of “F” from a new ranking system launched by medical group Do No Harm that ranks...
Plastics industry one of ‘most powerful economic engines’ thanks to nation’s shale gas, ingenuity

Plastics industry one of ‘most powerful economic engines’ thanks to nation’s shale gas, ingenuity

By Tate MillerThe Center Square The American plastics industry is one of the “most powerful economic engines” in the U.S. due to the nation’s ingenuity and its abundant and affordable...
Congressional candidate defends 'dark humor' video about Kirk assassination

Congressional candidate defends ‘dark humor’ video about Kirk assassination

By Elyse ApelThe Center Square A Michigan Democrat candidate for the U.S. House is doubling down after posting a video in the wake of the Charlie Kirk assassination stating: “Hey,...
Trump tells parents to get vaccines not available in U.S.

Trump tells parents to get vaccines not available in U.S.

By Brett RowlandThe Center Square President Donald Trump told parents Friday to break up measles, mumps and rubella vaccines and not get them in combinations, a preference not possible in...