Nov 22, 2025
3 min read
Hormone therapy is not a miracle solution to reverse aging, but it can significantly improve the disturbing symptoms that can reduce a person's quality of life.
For more than 20 years, menopausal hormone therapy has led the way in warnings from the Food and Drug Administration that describe the drug's risk of serious harm — namely, cancer, cardiovascular disease and possibly dementia.
On November 10, 2025, the FDA announced that drugs must remove these "black box" safety warnings.
The US Conversation asked Genevieve Hoffman, a women's nurse at the University of Colorado Anschutz Medical Campus, to explain how the decision will affect medical care for people going through menopause or postmenopause.
How did the FDA's decision come about?
When people think of hormone therapy for menopause, they usually think of systemic estrogens and progestogens—for example, pills or patches that release hormones throughout the body.
Medical providers administered hormone therapy to manage Hotoffice symptoms, such as hot flashes, night sweats, and brain fog in the 1980s and 1980s.This is because in the early 2000s, researchers found that hormone therapy, breast cancer, breast cancer, breast cancer, blood clots, blood clots, cognitive impairment and cognitive decline.
Use of hormone therapy dropped 46 percent in the six months after this research was first published in 2002. In 2003, the FDA added a black box warning - a serious box warning that indicates all hormone products that contain estrogen can cause serious harm or death.
However, the researchers were quick to point out methodological flaws in the analysis.Over the past two decades, careful reanalysis of the data from this study, as well as more recent studies, have shown that systemic hormone therapy is very safe for most women, although there are nuances to its use.
Currently, women's experts add, Black Beat Counnise Scapy's removal is delayed by five years compared to past years.It is used to deliver estrogen to the vagina and surrounding area, usually in the form of a cream or tint.It is used to treat menopausal syndrome, which is an example of middle and sad conditions.
Although topical estrogen products are very safe and have not been evaluated in the Women's Initiative Study, FDA approval has been extended to them.
In July 2025, the FDA convened an expert panel to review what is currently known about the risks and benefits of hormone therapy during menopause.Most experts at the meeting urged the agency to remove warning labels on topical vaginal estrogen products.
The Nov. 10 announcement was the result of discussions that included systemic and topical hormonal treatments.
Why is systemic estrogen no longer considered dangerous?
Researchers have now found that the balance of risks and benefits of systemic hormone therapy for menopause depends largely on when a person starts hormones and the type, dose, and duration of use.
Treatment is much safer for women under 60 or within 10 years of their last period than for older women.in 2017A follow-up of participants in the Women's Health Initiative found that this group of younger menopausal women who took hormones actually had a reduction in deaths from any cause.
For women who have been more than 10 years since their last period, starting hormone therapy may increase the risk of cardiovascular disease.Researchers now refer to this as the time hypothesis.Newer studies also support this idea.
In addition, several ways of delivering hormones to the body are safer than others.Took estrogen by mouth, in pill or tablet form, carries a higher risk of blood clots.The risks go off when it is administered by the skin with a patch, yellow or spray.There are many more hormone therapy options today as it were in the early 2000s.
In addition, it is well established that hormone therapy improves bone health by preventing bone loss.Some studies suggest that it can actually protect against cardiovascular disease in young menopausal women, although this link has not yet been proven and requires more research.
However, many people missed the time window.In my work, I see patients who went through menopause 10 or 15 years ago and did not receive hormone therapy when the results of the woman appeared.Now they are hearing about the benefits and many want to try it.But what's more, their chances are enough that they can fill the advantage.
What about topical estrogen?
Genitourinary syndrome of menopause is ubiquitous: it affects all postmenopausal people with ovaries and symptoms tend to worsen with age.
Including vaginal dryness, painful and organic symptoms such as urgent or frequent urination.Urinary tract infections tend to cause complications, especially in older women.They may need several courses of antibiotics.
The tissues of the genito-urinary area contain many estrogen receptors—proteins in cells that bind hormones.So adding a little estrogen to these areas can restore the quality and thickness of these tissues, and may even encourage the growth of healthy bacteria around the vagina and urinary tract.Treatment can significantly improve quality of life, health, and longevity.
Despite the safety and efficacy of topical estrogen, the FDA did not distinguish between estrogen and systemic estrogen when it added a black box warning in 2003.For this reason, many providers whose patients have symptoms related to menopausal genitourinary syndrome have been reluctant to prescribe it.Often, providers are simply unaware that it has a different safety profile than systemic estrogen.
How to open the darkcasters in patients?
Overall, I think this is a huge win for women and their ability to manage menopausal symptoms.I think this will allow doctors and patients to worry much less about prescribing and taking this drug.
Doctors like me who specialize in women's health and menopause - and who have followed the research - have safely prescribed hormone therapy all along.But many GPs, who often lacked menopause-specific training or the time and resources to stay abreast of the latest findings, have been more reluctant to do so.
The safety concerns that led to the black box warnings, especially regarding topical vaginal estrogen, turned out to be overblown.While doctors still have to consider who is a good candidate for using systemic hormones, the evidence shows that for most people, it's a safe option.
More importantly, patients who were previously convinced that hormone therapy was unsafe may feel more comfortable discussing it with their provider and considering it.And if they do receive a prescription for hormone therapy, hopefully their chances of starting this effective treatment won't be hindered by reading scary package inserts based on outdated evidence.
Although this drug is not a silver bullet that restores hormones at the right time it can reduce symptoms and improve people's quality of life.So if you have symptoms that are bothersome, consider asking your provider about hormone therapy to help manage them.
