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Is Hormone Replacement Therapy Safe?

Dec 19, 2025
Is Hormone Replacement Therapy Safe?
In light of recently updated guidance from the Department of Health and Human Services, we want to spotlight the safety of hormone replacement therapy.

Menopause is associated with a wide range of unwelcome changes. It can affect your physical comfort, your mental health, and the way you look. It’s no surprise that researchers have looked for ways to offset the negative effects of this season of transition.

And they found it. With hormone replacement therapy (HRT), women got notable relief from hot flashes, mood changes, and more. Then the Food and Drug Administration (FDA) applied broad “black box” warnings to HRT. Not surprisingly, that concerned a lot of women about its safety. 

Our team at Elite Gynecology offers hormone replacement therapy because we believe it’s both safe and effective. Today, we want to go over recent guidance from the FDA and the Department of Health and Human Services (HHS) as it underscores just how safe this treatment is. 

If you’re ready to explore HRT for yourself, visit our team in Manhattan, Forest Hills, or Rego Park, New York. 

Changing course: Expert recommendations on HRT

In the early 2000s, a study linked hormone replacement therapy with an increase in breast cancer cases. The FDA took that information and decided to apply broad boxed warnings to HRT. 

Fast forward to last month, and the FDA and HHS are reversing course. The agencies have issued a statement saying they’re removing the boxed warnings in light of a review of the latest scientific literature and guidance from an expert panel. 

The FDA/HHS statement acknowledges that: (1) The original boxed warning came from a “study that found a statistically non-significant increase in the risk of breast cancer diagnosis.” (2) The average age of the women in the study was 63, older than most women going through menopause and using HRT. (3) The study looked at participants using an HRT formulation that’s no longer commonly prescribed.

In other words, a lot of the fear and confusion around hormone replacement therapy came from an isolated, not statistically significant, study. 

To further drive home the safety of this treatment, an update to the aforementioned study found that women in their 50s who used HRT actually lowered their risk of dying by 30%. 

What to expect with HRT

If all of this has you rethinking hormone replacement therapy for yourself, come see our team. At Elite Gynecology, we tailor the dose and delivery method of your replacement hormones to you, meaning you don’t get more than you need, which helps make this treatment safer. 

We offer systemic HRT, which comes in forms like a pill or patch and helps offset the range of symptoms that come with menopause. If you want to limit how many replacement hormones you’re getting, we can explore vaginal estrogen, which you apply locally.

In short, you have options, and we can help you explore them and any safety concerns you have. To see what HRT could do for you, call Elite Gynecology or book a consultation online today.