In a landmark decision that rewrites more than two decades of medical guidance, the U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary announced at a press conference the removal of black box label warnings for hormone replacement therapy.
It’s a move called one of the most significant corrections in modern medicine. The DFA HHS (Health and Human Services) decision of removing black box warning from HRT medicines has come after almost 20 years, during which medical experts now say were based on flawed research and led to millions of women being denied potentially life-changing treatment.
“Maybe One of the Greatest Screw-Ups of Modern Medicine” At HHS headquarters on Monday, Commissioner Makary called it medical groupthink for spreading fear about a therapy he now ranks alongside antibiotics and vaccines in terms of impact.
“HRT has saved marriages, rescued women from depression, prevented children from going without a mother,” Makary said during the announcement. The announcement was attended by more than 200 people.
Basics of Hormone Replacement Therapy
As women go through menopause, their ovaries produce less estrogen and progesterone. FDA-approved HRT containing these hormones can help restore what’s naturally declining.
HRT is FDA-approved specifically for:
- Relief from vasomotor symptoms (hot flashes and night sweats)
- Treatment of vaginal and urinary symptoms caused by decreased estrogen
- Prevention of osteoporosis
Hormone therapy is the most effective treatment for women experiencing severe vasomotor symptoms. Research shows that serious menopause symptoms are present in more than 50 percent of women, can last up to eight years, and are often debilitating.
The HRT Label Change 2025: What's Different Now
The hormone replacement therapy update, FDA HHS removes black box labeling that warns about cardiovascular disease, breast cancer, and dementia. The only black box warning that remains is for women with a uterus taking estrogen alone, as that increases the risk of endometrial cancer.
This menopausal hormone therapy labeling change follows an FDA expert panel discussion held in July and what Makary described as the agency’s “robust review of the latest scientific evidence.”
How We Got Here: The 2002 Study That Changed Everything
In 2002, a large government-funded study called the Women’s Health Initiative was stopped early when an independent panel determined that the risks of taking a combination of estrogen and progesterone outweighed the benefits for study participants.
The FDA responded in 2003 by requiring black box warnings on hormone therapy products, the most serious type of warning the agency can require. But medical experts now say that the original study had significant limitations.
“Basically, we went from everybody wanting to put estrogen in the water to prevent heart disease, to then this black box label where you wouldn’t dare use it,” said Dr. Marcia Stefanick, a Stanford Prevention Research Center professor who was one of the original Women’s Health Initiative investigators. “And now we’re going back to ‘Let’s remove the black box label,’ so it feels like we really have come full circle.”
The Benefits of Starting HRT Within 10 Years of Menopause
For hormone replacement therapy safety, FDA research has evolved significantly, and we now understand that timing, dosage, and individual health factors all play crucial roles.
Hormone therapy, when started within 10 years of menopause onset or before age 60, may offer significant benefits, including:
- Heart disease risk protection
- Increased bone health
- Cognitive benefits
- Quality of life
Menopause Hormone Therapy FDA HHS Announcement
Commissioner Makary emphasized Monday that this decision doesn’t mean the government is prescribing treatment; it’s about removing barriers to informed conversations.
“We want people to talk to their doctors,” Makary said, “and we want doctors to have the right information, and part of that means removing these scary black box warnings and putting the nuanced discussion in the package insert of the medications.”
It’s important to note that hormone therapy isn’t the only option for menopause symptoms. In recent years, the FDA has approved two nonhormonal drugs, Veozah and Lynkuet, that can help women manage hot flashes.
Dr. Rebecca Thurston of the University of Pittsburgh School of Medicine hopes women and doctors will treat hormone therapy “like any other medication.”
If you’re experiencing menopause symptoms and wondering whether hormone therapy might be right for you, now is the time to have that conversation. The removal of black box warnings doesn’t mean HRT is right for everyone, but it does mean you deserve an informed discussion about your options.
As a trusted hormone therapy clinic near you for women throughout Georgia, Windermere Medical Group is here to help you navigate this new landscape of menopause care.
This hormone replacement therapy update, FDA HHS, represents a significant shift in how we approach menopause care. After 22 years of warnings based on flawed research, women now have the opportunity to make informed decisions.
Hormone therapy is neither a miracle cure-all nor a dangerous poison, but balance is key. It’s a medical treatment with both benefits and risks that vary from woman to woman.
