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: GOP leader calls Pritzker’s accountability commission a 'political stunt'

WATCH: GOP leader calls Pritzker’s accountability commission a ‘political stunt’

By Jim Talamonti | The Center SquareThe Center Square (The Center Square) – Illinois Gov. J.B. Pritzker has created a new government commission to document the conduct of federal law...
Unions sue Trump over immigrant drivers license crackdown

Unions sue Trump over immigrant drivers license crackdown

By Andrew RiceThe Center Square Two national public employee unions sued the Trump administration over its restrictions preventing illegal immigrants from obtaining commercial drivers licenses. The American Federation of Teachers...
Battery storage financials remain in question as lawmakers consider energy omnibus

Battery storage financials remain in question as lawmakers consider energy omnibus

By Jim Talamonti | The Center SquareThe Center Square (The Center Square) – State lawmakers are expected to include battery storage as part of an energy omnibus bill at the...
Illinois quick hits: Pritzker praises credit upgrade; Cook County approves $20M quantum grant

Illinois quick hits: Pritzker praises credit upgrade; Cook County approves $20M quantum grant

By Jim Talamonti | The Center SquareThe Center Square Pritzker praises credit upgrade Moody’s Investors Service has upgraded Illinois’ credit rating to A2 for the state’s general obligation bonds. Gov....
Op-Ed: Main Street businesses, customers would bear brunt of a tax on services

Op-Ed: Main Street businesses, customers would bear brunt of a tax on services

By Noah Finley | National Federation of Independent BusinessThe Center Square Even as lawmakers reconvene in Springfield for the fall veto session, special interest groups continue to press for higher...
Supreme Court grants extra time for arguments in tariff case

Supreme Court grants extra time for arguments in tariff case

By Brett RowlandThe Center Square The U.S. Supreme Court will grant some additional time for oral arguments in a case challenging President Donald Trump's tariff authority, but won't let tribal...

WATCH: White House vows to ‘fight’ lawsuits over $100,000 H-1B visa fee

By Andrew RiceThe Center Square The White House on Thursday vowed to fight legal challenges to President Trump’s $100,000 H-1B visa fee. White House Press Secretary Karoline Leavitt told reporters...
WATCH: Illinois leaders on both sides send Bailey family condolences for loss of 4

WATCH: Illinois leaders on both sides send Bailey family condolences for loss of 4

By Greg Bishop | The Center SquareThe Center Square (The Center Square) – Leaders on both sides of the political aisle are sending condolences to former state Sen. Darren Bailey’s...
Democrats tank GOP bill to pay troops, essential workers during govt shutdown

Democrats tank GOP bill to pay troops, essential workers during govt shutdown

By Thérèse BoudreauxThe Center Square Republicans’ attempts to avert the worst effects of the ongoing government shutdown failed Thursday after Senate Democrats blocked a bill that would ensure essential federal...
Texas lawmaker introduces agricultural visa reform

Texas lawmaker introduces agricultural visa reform

By Andrew RiceThe Center Square A Texas lawmaker introduced legislation to reform the H-2A visa program for agricultural workers. U.S. Rep. Monica De La Cruz, R-Texas, introduced the Bracero Program...
Home sales rise 1.5% in September as mortgage rates dip

Home sales rise 1.5% in September as mortgage rates dip

By Brett RowlandThe Center Square Home sales increased 1.5% in September as mortgage rates dipped, according to the National Association of Realtors. The group said September's 1.5% increase in existing-home...
FBI arrests 34 in NBA, poker gambling probe involving crime families

FBI arrests 34 in NBA, poker gambling probe involving crime families

By Jon StyfThe Center Square Thirty-one people including Miami Heat player Terry Rozier and Portland Trail Blazers coach Chauncey Billups were arrested along with 32 others on Thursday morning in...
Poll: Americans divided on Trump's deportation, immigration policies

Poll: Americans divided on Trump’s deportation, immigration policies

By Andrew RiceThe Center Square Americans are divided on President Donald Trump’s deportation and immigration policies, according to a new poll. The Center Square Voters’ Voice Poll found that 46%...
WATCH: Pritzker to sign exec. order to ‘pursue accountability’ amid federal deployments

WATCH: Pritzker to sign exec. order to ‘pursue accountability’ amid federal deployments

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 starts the program...
Helicopter crash claims lives of Bailey's son, daughter-in-law, grandchildren

Helicopter crash claims lives of Bailey’s son, daughter-in-law, grandchildren

By The Center SquareThe Center Square (The Center Square) – Illinois Republican gubernatorial candidate Darren Bailey’s campaign has released a statement following the death of Bailey’s son Zachary and his...