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

WATCH: Gov. Desantis addresses State Freedom Caucus Foundation in Dallas

By Greg BishopThe Center Square Florida Gov. Ron DeSantis addressed the State Freedom Caucus Foundation Friday night in Dallas.
Higher ed spending up as enrollment plummets at Illinois universities

Higher ed spending up as enrollment plummets at Illinois universities

By Jim Talamonti | The Center SquareThe Center Square (The Center Square) – A former state lawmaker says Illinois is now tops in the nation on per-student spending in higher...
World's largest retailer struggles to keep costs down as tariffs hit

World’s largest retailer struggles to keep costs down as tariffs hit

By Brett RowlandThe Center Square The world's largest retailer says it's doing everything it can to keep prices low as its costs increase each week due to the tariffs at...
Meeting Briefs

Meeting Summary and Briefs: Casey City Council for September 2, 2025

With Alderman Tanner Brown serving as Mayor Pro Tem in the absence of Mayor Mike Nichols, the Casey City Council's first meeting of September was dominated by positive reflections on...
billy-decker-1757676411

Billy Gene Decker, 91

Updated Service Information as of September 5, 2025. Billy Gene Decker, 91, of Casey, Illinois, passed away at 9:45 p.m. on Tuesday, May 19, 2020, at Sarah Bush Lincoln Health...
Boston judge orders Trump to give back Harvard funding

Boston judge orders Trump to give back Harvard funding

By Esther WickhamThe Center Square A Boston federal judge this week blocked the Trump administration’s $2.2 billion funding freeze against Harvard after the government's claims of antisemitism. The U.S. District...
Arizona congressman backs bill protecting ICE agents

Arizona congressman backs bill protecting ICE agents

By Chris WoodwardThe Center Square U.S. Rep. Abe Hamadeh wants to protect ICE agents. The Arizona congressman is among a handful of House representatives, all of them Republicans, to introduce...
Northwestern president steps down amid federal funding cuts

Northwestern president steps down amid federal funding cuts

By Esther WickhamThe Center Square Northwestern University President Michael Schill resigned this week amid the federal funding freeze by the Trump administration. Schill has served as the 17th president of...
Feds sue Southern California Edison over Eaton, Fairview fires

Feds sue Southern California Edison over Eaton, Fairview fires

By Dave MasonThe Center Square The U.S. Department of Justice is suing electric utility company Southern California Edison for tens of millions of dollars over the devastating Eaton and Fairview...

WATCH: Trump renames DOD to ‘Department of War’

By Morgan SweeneyThe Center Square What’s in a name? Military victories, according to the Trump administration. The Department of Defense is reverting to its old name – the Department of...
Push to ban stock trading by Congress follows IL rep’s reported violations

Push to ban stock trading by Congress follows IL rep’s reported violations

By Jim TalamontiThe Center Square After an Illinois congressman reportedly broke the law with late disclosures of stock trades, another member of the state’s delegation is urging colleagues to prohibit...
Federal judge strikes down New Hampshire's DEI ban

Federal judge strikes down New Hampshire’s DEI ban

By Chris WadeThe Center Square A federal judge in New Hampshire has temporarily blocked a state law targeting diversity, equity and inclusion programs in public schools. The ruling issued Thursday...
Illinois quick hits: Giannoulias orders village to stop sharing data with CBP

Illinois quick hits: Giannoulias orders village to stop sharing data with CBP

By Jim Talamonti | The Center SquareThe Center Square License plate camera data Illinois Secretary of State Alexi Giannoulias has ordered the Village of Forest Park and Motorola Solutions to...
CA, Delaware attorneys general concerned about OpenAI

CA, Delaware attorneys general concerned about OpenAI

By Dave MasonThe Center Square California Attorney General Rob Bonta is investigating OpenAI after parents blamed the company for their teenage son’s suicide in a lawsuit. Bonta’s office said the...
New York AG to appeal ruling tossing Trump's $454M civil fraud penalty

New York AG to appeal ruling tossing Trump’s $454M civil fraud penalty

By Chris WadeThe Center Square New York Attorney General Letitia James will appeal a ruling that tossed out the half-billion-dollar penalty against President Donald Trump as part of the guilty...