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

Democrat Mills to challenge Collins with for U.S. Senate

Democrat Mills to challenge Collins with for U.S. Senate

By Chris WadeThe Center Square Maine's Democratic Gov. Janet Mills is expected to announce a bid for the U.S. Senate with a challenge to Republican Sen. Susan Collins in next...
Some New York school districts spend almost or more than $100,000 a student

Some New York school districts spend almost or more than $100,000 a student

By Mark StricherzThe Center Square A half-dozen school districts in New York state reported spending more than $70,000 per student recently, with two districts spending almost or more than $100,000,...
Illinois quick hits: Chicago Jewish Alliance on peace developments; Blue Ribbon Schools announced

Illinois quick hits: Chicago Jewish Alliance on peace developments; Blue Ribbon Schools announced

By Jim Talamonti | The Center SquareThe Center Square Chicago Jewish Alliance on peace developments The Chicago Jewish Alliance has offered a response to the release of 20 hostages held...
WATCH: Trump’s emergency Guard appeal denied; Fiscal Fallout reviews state salaries

WATCH: Trump’s emergency Guard appeal denied; Fiscal Fallout reviews state salaries

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 gets to the...
Reforms prompt big money appeals in IL biometrics cases

Reforms prompt big money appeals in IL biometrics cases

By Jonathan Bilyk | Legal NewslineThe Center Square Even as reforms seem to have edged down the number of biometric privacy lawsuits targeted at businesses in Illinois, appeals courts are...
Trump delivers message of peace, hope during historic Knesset address

Trump delivers message of peace, hope during historic Knesset address

By Sarah Roderick-FitchThe Center Square Hope and joy dominated the streets of Israel on Monday as 20 hostages were freed, and President Donald Trump addressed the State of Israel. The...
Meeting Briefs

Meeting Summary and Briefs: Casey City Council for October 6, 2025

The Casey City Council approved a 3-cent per kilowatt-hour increase for the city’s electric utility at its meeting on Monday, October 6, 2025, a move officials said was necessary to...
Casey Council Meeting.1

Casey Amends Nuisance Ordinance to Standardize Penalties

Article Summary: The Casey City Council has approved an ordinance to ensure penalties for nuisance violations are consistent across all sections of the city code. The "clean-up" measure follows a...
Everyday Economics: Data blackout: Why the growth narrative doesn't hold up

Everyday Economics: Data blackout: Why the growth narrative doesn’t hold up

By Orphe DivounguyThe Center Square The federal shutdown has darkened the dashboard. Key September releases are delayed – most notably CPI now slated for Oct. 24, just days before the...
Appeals Court rejects Trump administration bid to lift TRO in Illinois’

Appeals Court rejects Trump administration bid to lift TRO in Illinois’

By Jim Talamonti | The Center SquareThe Center Square (The Center Square) – The Seventh Circuit U.S. Court of Appeals has denied the portion of the Trump administration’s emergency motion...
Those doxxing, threatening ICE agents, arrested, indicted

Those doxxing, threatening ICE agents, arrested, indicted

By Bethany BlankleyThe Center Square Individuals rioting, doxxing and threatening U.S. Immigration and Customs Enforcement officers and their families continue to be arrested and indicted. Legal action is being taken...
'The Art of the Heal': How TrumpRx, most-favored nation pricing, Big Pharma intersect

‘The Art of the Heal’: How TrumpRx, most-favored nation pricing, Big Pharma intersect

By Morgan SweeneyThe Center Square AstraZeneca has now joined Pfizer in agreeing to sell its drugs to state Medicaid programs at “most-favored-nation” pricing and deeply discounted rates on TrumpRx.gov But...

GOP stands up for U.S. military strikes on suspected drug boats

By Brett RowlandThe Center Square President Donald Trump and the Pentagon show no signs of changing course on using military strikes to destroy suspected drug boats in the Caribbean. "We...
IL lawmakers could address energy prices, transit, taxes during veto session

IL lawmakers could address energy prices, transit, taxes during veto session

By Jim Talamonti | The Center SquareThe Center Square (The Center Square) – The Illinois General Assembly’s fall veto session begins Tuesday, and taxes are expected to be part of...
Screenshot 2025-10-08 at 9.41.03 AM

Council Approves Over $86,000 in Infrastructure Contracts

Article Summary: The Casey City Council awarded three separate contracts totaling over $86,000 for sidewalk replacement, city-wide tree removal, and stump grinding. The winning bids were selected from multiple submissions...