For more than 20 years, hormone therapy for menopause has carried a warning label from the Food and Drug Administration describing the medication’s risk of serious harms – namely, cancer, cardiovascular disease and possibly dementia.

On Nov. 10, 2025, the FDA announced that drugmakers should remove these “black box” safety warnings.

The Conversation U.S. asked Genevieve Hofmann, a women’s health nurse practitioner at the University of Colorado Anschutz Medical Campus, to explain how the decision will affect health 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 generally think of systemic estrogen and progestogens – for example, pills or patches that deliver hormones throughout the body.

Health care providers prescribed hormone therapy to manage symptoms of menopause such as hot flashes, night sweats and brain fog much more widely in the 1980s and 1990s than they do today. That’s because in the early 2000s, researchers analyzed data from a study called the Women’s Health Initiative and reported that hormone therapy increased the risk of breast cancer, heart disease, blood clots and stroke, as well as cognitive decline after menopause.

After this research was first published in 2002, the use of hormone therapy fell by 46% within six months – both because clinicians were reluctant to prescribe it and patients were fearful of taking it. In 2003, the FDA added black box warnings – the most serious warnings, indicating a risk of serious harm or death – to all estrogen-containing hormone products for menopause.

But researchers soon pointed out methodological flaws in the analysis. And over the past two decades, careful reanalyses of data from that study, as well as newer studies, have shown that systemic hormone therapy is very safe for most women, though there are nuances surrounding its use.

Meanwhile, women’s health experts have been increasingly vocal in the past five years in calling to remove the black box warnings from a form of hormone menopause therapy that’s applied locally, not systemically. Topical localized estrogen is applied directly to the vagina and surrounding areas, usually in the form of a cream or vaginal insert. It’s used to treat the genitourinary syndrome of menopause, which manifests as genital and urinary symptoms.

Even though topical estrogen products are extremely safe and were not evaluated in the Women’s Health Initiative study, the FDA warnings were added to them, too.

In July 2025, the FDA held an expert panel to discuss what’s currently known about the risks and benefits of hormone therapy for menopause. At the meeting, most experts urged the agency to remove the warning labels on topical vaginal estrogen products.

The Nov. 10 announcement was the outcome of that discussion, and it included both systemic and topical hormone therapy.

Why is systemic estrogen no longer considered unsafe?

Researchers are now finding that the balance of risks and benefits of systemic hormone therapy for menopause seems to depend strongly on when someone starts hormones, as well as the type, dose and length of use.

For women under 60 or within 10 years of their final period, the therapy is much safer than it is for older women. A 2017 follow-up of Women’s Health Initiative participants showed that overall deaths from any causes actually decreased in this younger cohort of menopausal women taking hormones.

For women who are more than 10 years from their final menstrual period, starting hormone therapy may increase their risk of cardiovascular disease. Researchers now refer to this as the timing hypothesis. Newer studies also support this idea.

Also, some ways of delivering hormones to the body turned out to be safer than others. Taking estrogen orally, as pills or tablets, carries a higher risk of blood clots. Those risks go away when it’s delivered through the skin using a patch, gel or spray. Many more options for hormone therapy exist today than in the early 2000s.

Additionally, it’s well established that hormone therapy improves bone health by preventing bone loss. Some studies suggest that in younger menopausal women, it may actually protect against cardiovascular disease, though this link is not yet proven and needs more study.

Unfortunately, many people missed out on the timing window. In my practice, I see patients who went through menopause 10 or 15 years ago and either didn’t get hormone therapy at the time or stopped taking it when the initial Women’s Health Initiative results came out. Now, they are hearing about the benefits, and many want to try it. But their higher cardiovascular risk may overshadow the benefit.

What about topical estrogen?

Genitourinary syndrome of menopause is ubiquitous – it affects every person with ovaries who goes through menopause, and the symptoms tend to worsen with age.

They include vaginal dryness, painful sex and urinary issues such as an increase in urgency or frequency, along with incontinence. Urinary tract infections often tend to get more frequent with menopause, particularly in older women. Treating them can require multiple courses of antibiotics.

Tissues in the genitourinary area are loaded with estrogen receptors – proteins in cells that bind the hormone. So adding some estrogen back to these areas can help restore the quality and thickness of these tissues, and possibly even promote the growth of healthy bacteria around the vagina and the urinary tract. The treatment can greatly improve quality of life and promote better health and longevity.

Despite topical estrogen’s safety and effectiveness, the FDA did not distinguish between it and systemic estrogen when adding the black box warnings in 2003. For this reason, many providers whose patients have symptoms relating to the genitourinary syndrome of menopause have been reluctant to prescribe it. Often, providers simply don’t know that it has a different safety profile than systemic estrogen.

How will removing the black box warnings affect patients?

Overall, I see this as a big win for women and their ability to manage the symptoms of menopause. I think this will make clinicians and patients far less anxious about prescribing and taking this medication.

Clinicians like me who specialize in women’s health and menopause – and who have been following the research – have been safely prescribing hormone therapy all along. But many general practitioners who often lacked either menopause-specific training or the time and resources to stay on top of the latest findings have been more reluctant to do so.

Safety concerns that led to the black box warnings, especially in regard to local vaginal estrogen, have turned out to be overblown. While clinicians still need to consider who is a good candidate for systemic hormone use, the evidence shows that for most people, it is a safe option.

Even more important, 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, I hope that the likelihood of them starting this effective treatment is no longer hindered by reading a scary package insert that was based on outdated evidence.

While this medication is not a silver bullet that reverses aging, starting hormones at the right time can safely improve symptoms that diminish people’s quality of life. So if you’re having symptoms that are bothersome, consider asking your provider about menopause hormone therapy to help manage them.

Genevieve Hofmann, Assistant Professor of Nursing and Women's Health, University of Colorado Anschutz Medical Campus

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Hollywood legend Gene Hackman and his wife, Betsy Arakawa, were found dead in their home in February 2025. Hackman had been living with Alzheimer’s and depended on Arakawa as his full-time caregiver.

Disturbingly, postmortem data suggests that Arakawa died of complications from pulmonary Hantavirus several days before her husband passed. The discordant times of death point to a grim scenario: Hackman was left alone and helpless, trapped in his home after his wife’s death.

The couple’s story, while shocking, is not unique. It serves as a warning for our rapidly aging society. The U.S. population is aging, but most Americans are not adequately planning to meet the needs of older adulthood.

As a geriatric physician and medical educator, I care for older adults in both inpatient and outpatient settings. My research and clinical work focus on dementia and surrogate decision-making.

In my experience, regardless of race, education or socioeconomic status, there are some universal challenges that all people face with aging and there are steps everyone can take to prepare.

Aging is inevitable but unpredictable

Aging is an unpredictable, highly individualized process that varies depending on a person’s genetics, medical history, cognitive status and socioeconomic factors.

The majority of older Americans report a strong sense of purpose and self-worth. Many maintain a positive view of their overall health well into their 70s and 80s.

But at some point, the body starts to slow down. Older adults experience gradual sensory impairment, loss of muscle mass and changes in their memory. Chronic diseases are more likely with advancing age.

According to the U.S. Census Bureau, 46% of adults over age 75 live with at least one physical disability, and this proportion grows with age. Even those without major health issues may find that routine tasks like yard work, housekeeping and home repairs become insurmountable as they enter their 80s and 90s.

Some may find that subtle changes in memory make it difficult to manage household finances or keep track of their medications. Others may find that vision loss and slowed reaction time make it harder to safely drive. Still others may struggle with basic activities needed to live independently, such as bathing or using a toilet. All of these changes threaten older adults’ ability to remain independent.

The costs of aging

Nearly 70% of older Americans will require long-term care in their lifetime, whether through paid, in-home help or residence in an assisted living facility or nursing home.

But long-term care is expensive. In 2021, the Federal Long Term Care Insurance Program reported that the average hourly rate for in-home care was US$27. An assisted living apartment averaged $4,800 per month, and a nursing home bed cost nearly double that, at a rate of $276 per day.

Many Americans may be shocked to discover that these costs are not covered by Medicare or other traditional medical insurance. Long-term care insurance covers the cost of long-term care, such as in-home care or nursing home placement. However, what is covered varies from plan to plan. Currently, only a small minority of Americans have long-term care insurance due to high premiums and complex activation rules.

I am not aware of any high-quality, peer-reviewed studies that have demonstrated the cost effectiveness of long-term care insurance. Yet, for many Americans, paying for care out of pocket is simply not an option.

Medicaid can provide financial support for long-term care but only for older adults with very low income and minimal assets – criteria most Americans don’t meet until they have nearly exhausted their savings.

Those receiving Medicaid to cover the costs of long-term care have essentially no funds for anything other than medical care, room and board. And proposed federal financial cuts may further erode the limited support services available. In Michigan, for example, Medicaid-covered nursing home residents keep only $60 per month for personal needs. If individuals receive monthly income greater than $60 – for instance, from Social Security or a pension – the extra money would go toward the cost of nursing home care.

Those who don’t qualify for Medicaid or cannot afford private care often rely on family and friends for unpaid assistance, but not everyone has such support systems.

Planning for the care you want

Beyond financial planning, older adults can make an advance directive. This is a set of legal documents that outlines preferences for medical care and asset management if a person becomes incapacitated. However, only about 25% of Americans over 50 have completed such documentation.

Without medical and financial powers of attorney in place, state laws determine who makes critical decisions, which may or may not align with a person’s wishes. For instance, an estranged child may have more legal authority over an incapacitated parent than their long-term but unmarried partner. Seniors without clear advocates risk being placed under court-appointed guardianship – a restrictive and often irreversible process.

In addition to completing advance directives, it is important that older adults talk about their wishes with their loved ones. Conversations about disability, serious illness and loss of independence can be difficult, but these discussions allow your loved ones to advocate for you in the event of a health crisis.

Who’s going to care for you?

Finding a caregiver is an important step in making arrangements for aging. If you are planning to rely on family or friends for some care, it helps to discuss this with them ahead of time and to have contingency plans in place. As the Hackman case demonstrates, if a caregiver is suddenly incapacitated, the older adult may be left in immediate danger.

Caregivers experience higher rates of stress, depression and physical illness compared with their peers. This is often exacerbated by financial strain and a lack of support. It helps if the people you will be relying on have expectations in place about their role.

For instance, some people may prefer placement in a facility rather than relying on a loved one if they can no longer use the bathroom independently. Others may wish to remain in their homes as long as this is a feasible option.

Connecting with available resources

There are local and federal initiatives designed to help aging adults find and get the help they need. The Centers for Medicare & Medicaid Services recently launched the GUIDE Model to improve care and quality of life for both those suffering from dementia and their caregivers.

This program connects caregivers with local resources and provides a 24-hour support line for crises. While GUIDE, which stands for Guiding an Improved Dementia Experience, is currently in the pilot stage, it is slowly expanding, and I am hopeful that it will eventually expand to provide enhanced coverage for those suffering from dementia nationwide.

The Program for All-Inclusive Care of the Elderly helps dual-eligible Medicare and Medicaid recipients remain at home as they age. This program provides comprehensive services including medical care, a day center and home health services.

Area agencies on aging are regionally located and can connect older adults with local resources, based on availability and income, such as meals, transportation and home modifications that help maintain independence.

Unfortunately, all of these programs and others that support older adults are threatened by recent federal budget cuts. The tax breaks and spending cuts bill, which was signed into law in July 2025, will result in progressive reductions to Medicaid funding over the next 10 years. These cuts will decrease the number of individuals eligible for Medicaid and negatively affect how nursing homes are reimbursed.

The government funding bill passed on Nov. 13 extends current Medicare funding through Jan. 30, 2026, at which point Medicare funding may be reduced.

Even as the future of these programs remains uncertain, it’s important for older adults and their caregivers to be intentional in making plans and to familiarize themselves with the resources available to them.

Kahli Zietlow, Physician and Clinical Associate Professor of Geriatrics & Internal Medicine, University of Michigan

This article is republished from The Conversation under a Creative Commons license. Read the original article.