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

Tyler Farr_5048

Tyler Farr Rocks Casey, Takes a Seat Atop World’s Largest Chair

CASEY, IL – Country music star Tyler Farr brought his chart-topping hits and down-to-earth charm to Casey this weekend, delivering a memorable headlining performance at the Casey Popcorn Festival on...
Bessie, provided by the Stan Keeney family, paces the squares while everyone anxiously awaits, hoping she’ll stop on their square. —photo by Sharon Durham

Keeney Family Donates to Bessie Bingo

Bessie, provided by the Stan Keeney family, paces the squares while everyone anxiously awaits, hoping she’ll stop on their square. —photo by Sharon Durham
Lauren Repp was the winner of the Casey Rotary annual Bessie Bingo fundraiser. Lauren (right) received the $1,000 donation from Casey Rotary Club President Marcy Mumford (left). Also pictured is Rotarian Jay Markwell. —photo by Sharon Durham

Bessie Bingo Winner

Lauren Repp was the winner of the Casey Rotary annual Bessie Bingo fundraiser. Lauren (right) received the $1,000 donation from Casey Rotary Club President Marcy Mumford (left). Also pictured is...
Rotararians at work! Pictured (l to r) are Gary Shore, Jay Markwell, and Aaron Stinson. —photo by Sharon Durham

Rotararians at work!

Rotararians at work! Pictured (l to r) are Gary Shore, Jay Markwell, and Aaron Stinson. —photo by Sharon Durham
Section 8 covers Colorado rents up to $3,879 per month, 'lap of luxury'

Section 8 covers Colorado rents up to $3,879 per month, ‘lap of luxury’

By Kenneth SchruppThe Center Square Taxpayers are covering rents of up to $3,879 per month in Colorado, leading taxpayer advocates to question the growing duration of federal Section 8 housing...
House Oversight Committee releases trove of Epstein documents

House Oversight Committee releases trove of Epstein documents

By Sarah Roderick-FitchThe Center Square More than 33,000 pages related to the Jeffrey Epstein case have been released by the U.S. Department of Justice after the House Committee on Oversight...
WATCH: Trump says 'we’re going in' as Pritzker pushes for money instead of troops

WATCH: Trump says ‘we’re going in’ as Pritzker pushes for money instead of troops

By Jim Talamonti | The Center SquareThe Center Square (The Center Square) – President Donald Trump has promised to send federal crime-fighting help to Chicago, but Illinois Gov. J.B. Pritzker...

WATCH: Trump to push Supreme Court for quick ruling on tariff authority

By Brett RowlandThe Center Square President Donald Trump said Tuesday that his administration will ask the U.S. Supreme Court on Wednesday to quickly take up his appeal on tariff authority...
Newsom seeks to regain control of rest of National Guard

Newsom seeks to regain control of rest of National Guard

By Dave MasonThe Center Square California Gov. Gavin Newsom is seeking another courtroom victory against President Donald Trump after a federal judge Tuesday ruled in Newsom’s favor over the National...
GOP scrutinizing litigation group that 'educated' 2,000+ judges on climate change

GOP scrutinizing litigation group that ‘educated’ 2,000+ judges on climate change

By Thérèse BoudreauxThe Center Square Republicans on the House Judiciary Committee have launched a probe into the Environmental Law Institute over allegations the group has tried to influence the impartiality...
Routh, representing himself, begins picking Florida jury Monday

Routh, representing himself, begins picking Florida jury Monday

By Alan WootenThe Center Square Ryan Routh will have court-appointed lawyers nearby as he represents himself in a Florida court against charges related to assassinating Donald Trump. Jury selection starts...
SPACECOM will leave Colorado for Alabama’s Rocket City

SPACECOM will leave Colorado for Alabama’s Rocket City

By Alan WootenThe Center Square U.S. Space Command Headquarters will move to Alabama from Colorado. Calling Huntsville by its beloved “Rocket City” nickname, second-term Republican President Donald Trump reversed yet...
Trump administration releases AmeriCorps funding

Trump administration releases AmeriCorps funding

By Elyse ApelThe Center Square The White House Office of Management and Budget will release over $184 million in paused funding for AmeriCorps service programs. This comes after a coalition...
Illinois quick hits: DOJ sues over financial support for illegal aliens; state opposes proposed labor rule change

Illinois quick hits: DOJ sues over financial support for illegal aliens; state opposes proposed labor rule change

By Jim Talamonti | The Center SquareThe Center Square DOJ sues over financial support for illegal aliens The U.S. Department of Justice and the U.S. Attorney for the Southern District...
WATCH: Chicago residents: 'We need help' from feds to fight crime

WATCH: Chicago residents: ‘We need help’ from feds to fight crime

By Jim Talamonti | The Center SquareThe Center Square (The Center Square) – As the Illinois Freedom Caucus and Chicago Flips Red join forces to invite President Donald Trump’s crime...