The recommendations surrounding menopausal hormone therapy (MHT, HRT) have been changing rapidly over the past few years. The perception that "hormone therapy is dangerous," which had hardened for over 20 years since the 2002 WHI study, is shifting—amid re-examinations by the latest societies and regulatory agencies—toward a precise judgment that weighs "who, when, and how to use it." In the clinic, this change sometimes confuses patients. This article is not to recommend a specific treatment, but to organize, from a clinical viewpoint, how far the recent guidelines have come.
The black-box warning—what has changed?
The most symbolic change is the decision of the U.S. FDA. In July 2025, the FDA held an expert advisory panel meeting on the topic of menopause and hormone therapy, and a majority of the panel gave the opinion of relaxing or removing the black-box warning on product labels. Afterward, in November 2025, the FDA announced that it would remove the black-box warning that had emphasized the risks of cardiovascular disease, breast cancer, and dementia in estrogen-containing hormone therapy products.
However, there is a part that must not be misunderstood. The warning is not disappearing entirely. The warning about endometrial cancer risk for systemic estrogen products is maintained, and the label is reported to be rewritten in a direction that includes age-specific guidance. In other words, it is closer to a reinterpretation that "a uniform warning did not match the evidence" rather than "the risk has disappeared."
The relaxation of the warning wording does not mean hormone therapy has become safe; it is more accurate to read it as a signal that accumulated evidence—that risk and benefit must be viewed differently by age and timing—has begun to be reflected in regulation.
The timing hypothesis—the key is the timing of starting
The academic foundation of this change is the so-called timing hypothesis. The North American Menopause Society (NAMS, The Menopause Society), in its 2022 hormone therapy recommendations, organized that for healthy symptomatic women under 60 or within 10 years of the onset of menopause, the benefit generally outweighs the risk. It means that for the same drug, the risk-benefit balance differs between starting relatively young right after menopause and starting long after menopause.
This perspective is also confirmed in the reinterpretation of the WHI study itself. The WHI long-term follow-up review published in 2024 emphasized that in the relatively younger group under 60, adverse-event occurrence was low and the benefit-risk balance was more favorable. The researchers also stated that the WHI results should not be used as grounds to refuse hormone therapy for symptomatic women in early menopause. One of the misunderstandings I often see in the clinic is the oversimplification that "WHI concluded hormone therapy is dangerous," when in fact the researchers themselves are saying it should be interpreted by distinguishing age.
Preventive purpose and symptom treatment are distinguished
The point most often tangled when reading guidelines is the distinction of indications. In 2022, the U.S. Preventive Services Task Force (USPSTF) took the position (Grade D) of not recommending the use of hormone therapy for the primary prevention of post-menopausal chronic diseases. However, this recommendation is limited to the case of asymptomatic women using it for chronic-disease prevention, and it specified that it does not apply to the treatment of menopausal symptoms such as hot flashes or vaginal dryness, or to premature menopause.
To sum up, the two recent trends are not contradictory.
| Purpose | Direction of recent guidelines |
|---|---|
| Prevention of chronic diseases such as heart disease/dementia | Use for preventive purposes is not recommended (USPSTF 2022) |
| Treatment of menopausal symptoms such as hot flashes/vaginal dryness | In women whose timing is right, the benefit may outweigh the risk (NAMS 2022) |
| Label warning | Readjusted from uniform emphasis to age-specific guidance (FDA 2025) |
It means that viewing hormone therapy like a chronic-disease prevention drug makes it hard to recommend, but viewing it as treatment for menopausal symptoms that lower quality of life changes the evaluation. Which purpose you fall under can be judged only by weighing menopausal symptoms and risk factors together.
If menopausal symptoms are affecting your daily life, you can organize how the guidelines apply to you through First consult by chat.
Systemic and local therapies have different risks
Another part often confused is the formulation. The point that low-dose local estrogen used for local symptoms such as vaginal dryness or painful sex is absorbed systemically in small amounts, and so is hard to regard at the same level of risk as systemic therapy, has long been noted. In the FDA panel discussion too, the opinion was raised that the uniform emphasis warning on local low-dose products is excessive.
In my clinical experience, this distinction is practically important to patients. Because of the perception that "hormones are unconditionally dangerous," it is not uncommon for people to endure vaginal dryness or discomfort during the relationship, but systemic and local therapies differ in both indications and risk profiles. Since which formulation is appropriate differs depending on the type of symptom and one's own health history, it is desirable to discuss it individually at menopause hormone treatment.
Korea's usage patterns and individualization
Looking at domestic data, a tendency is observed in which systemic menopausal hormone therapy is used for a relatively short period and discontinued. There are those who start and quit early out of vague anxiety, while there are also cases of continuing for a long period without sufficient consultation. Whichever it is, the key is the same. It is an individualized approach that looks at the following elements together and re-evaluates regularly.
- Timing of starting: whether within 10 years after menopause, whether under 60
- Purpose of treatment: whether for symptom relief or for chronic-disease prevention
- Existing risk factors: family history of breast cancer, history of thrombosis/cardiovascular disease, etc.
- Choice of formulation: whether systemic therapy or local low-dose
The American College of Obstetricians and Gynecologists (ACOG) also emphasizes an effective minimum dose and individualized evaluation for menopausal symptoms. For those for whom hormone therapy is not suitable, non-hormonal options are also considered together. This is also why a procedure of checking breast/uterine/thrombosis risks and so on through menopause screening before and after starting is recommended.
The news that guidelines have been relaxed does not mean "now anyone may receive hormone therapy." Rather, it is closer to a message to decide more precisely, weighing whether it suits you.
How to take in the change
Summing up the recent flow in one sentence, the evaluation of hormone therapy is shifting from the dichotomy of "dangerous or not" to a contextual judgment of "who, when, and for what purpose uses it." The FDA's label readjustment, NAMS's timing hypothesis, USPSTF's distinction of indications, and the WHI reinterpretation, though they look different, point in the same direction.
However, this change does not apply immediately in all cases, and the conclusion can differ depending on individual health condition and risk factors. If you are troubled by menopausal changes, please inquire through a chat consultation about how the guidelines apply to your situation.
Written by: Lee Dong-hee, Director · OB-GYN specialist · View doctor profile
First published October 14, 2025 · Last reviewed May 30, 2026
References: U.S. FDA (2025), The Menopause Society NAMS Hormone Therapy Position Statement (2022), USPSTF (2022), Women's Health Initiative Long-term Review JAMA (2024), ACOG (2023)
This article is intended to provide general health information and does not replace individual diagnosis or treatment. If you have symptoms, please consult through an examination.