You may be wondering, “How often are black box warnings removed by the FDA?” The removal of a black box warning is rare and has only occurred 3 times in the last decade, with the newest occurring on November 10, 2025, regarding hormone replacement therapy for women experiencing symptoms of menopause.
This announcement by the HHS (Department of Health and Human Services) comes after more than 20 years of fear and confusion surrounding the use of HRT (hormone replacement therapy) and the warning labels that appear on these prescription medications.
These warnings were added to HRT medications in the early 2000s after a large study, called the Women’s Health Initiative, reported that HRT might slightly increase the risk of breast cancer and heart problems for women who used them. The information reported in this study is outdated, and the results did not accurately represent the demographic the medication was intended for. The old research used women with an average age of 63, which is much older than the typical age a woman begins menopause, and the hormone formulation used in that 25-year-old research is no longer relevant.
What Is a Black Box Warning?
A black box warning, or “boxed warning,” is the strongest and most serious safety warning that the U.S. Food and Drug Administration (FDA) can require a prescription medication to carry.
It is normally placed inside a thick black border on the drug’s label and package insert, and usually appears at the top of the prescribing information so it cannot be missed. It is used to ensure that doctors and patients know and understand that there are serious or life-threatening risks linked to the medication.
Navigating Menopause Madness with Dr. Angelina | The Portia Show
Menopause can feel like madness with symptoms like hot flashes, weight gain, and memory loss. On this episode of The Portia Show, triple board-certified surgeon Dr. Angelina Postoev joins Portia to explain how our bodies change through the different stages of menopause and what treatment can help.
The FDA Commissioner and HHS Secretary Robert F. Kennedy Jr. Agree on Decision to Walk Back Warnings on HRT Medication
HHS Secretary Robert F. Kennedy Jr. said that this decision is a step toward restoring trust in women’s health care and said that women deserve medical decisions based on actual scientific data and not fear. Dr. Marty Makary, FDA Commissioner, agreed saying that millions of women have missed out on the benefits of HRT because of misleading information and unnecessary caution.
Why Did the FDA Remove the Warning on HRT Medications?
The FDA invited a panel of experts to come together in a public forum to discuss menopause and hormone replacement therapy for women. Among these experts were top researchers, doctors, and experts from a mix of leading medical institutions that focus on women’s health, cardiovascular medicine, urology, and menopause.
The group carefully reviewed newer research that consistently showed that women who begin HRT before the age of 60, or within 10 years of menopause, experienced better results with fewer risks than the older women that the original research was based on.
After the panel meeting, the FDA opened up a docket for public comment (FDA-2025-N-2589) that solicited feedback from doctors, advocacy groups, and regular women who use or have considered HRT. The American College of Obstetricians and Gynecologists (ACOG) and the National Consumers League (NCL) also showed their support for removing the warning and reported that the boxed warning discouraged doctors from prescribing safe and effective hormone treatments and that this label caused unnecessary fear and discouraged women from obtaining these low-dose estrogen products that could ease symptoms and improve their quality of life.
After analyzing all the recent data, the FDA determined that the earlier research overstated the dangers of hormone therapy, especially when applied to younger women at the start of menopause. This new understanding made it clear that the way the warning was currently written was no longer in agreement with the science and was outdated. By combining updated evidence, expert insight, and public feedback, the FDA determined that the black box warning did more harm than good and made the decision to remove it and open up dialogue between patients and their doctors to choose the best treatment option for them.
Will HRT Products Still Have Warnings?
Yes. The FDA is changing the warning labels on many hormone replacement therapy products for menopause, but not all the warnings are going away. They are removing the strongest warnings (black box warnings) about heart disease, breast cancer, and dementia for most products, which means the labels will no longer use the big black box to highlight these risks, but some warnings will remain. Women who take estrogen alone and still have a uterus will still see a black box warning about the risk of endometrial cancer, and labels will also continue to give important safety information so women and their doctors can make informed choices.
New FDA-approved Medications Are Available for HRT
The FDA recently approved two new medications to help alleviate symptoms of menopause. One is the first generic version of Premarin, which is commonly prescribed for estrogen therapy. It will make this type of HRT cost significantly less and will be easier for women to access without sacrificing quality, safety, or effectiveness.
The second approval is for a non-hormonal medication that helps reduce the instances of moderate to severe hot flashes (vasomotor symptoms). This prescription is designed for women who are unable to use, or prefer not to use, HRT and works by blocking the specific receptors in the brain that help control body temperature to lessen the frequency and intensity of hot flashes.
These timely approvals are significant because they offer women more choices for managing unpleasant symptoms related to menopause and at a more affordable cost.
Where Can I Get Help With Hormone Replacement Therapy?
Hormone Replacement Therapy can help alleviate menopausal symptoms and improve your quality of life. The recent updates by the FDA are long overdue and will go a long way to ensuring that women do not needlessly suffer because of unfounded fear or an affordability issue.
Doctor Angelina Postoev, a triple board-certified cosmetic surgeon with IBI Plastic Surgery & Med Spa, offers hormone replacement therapy and has over 20 years of experience helping women just like you comfortably navigate through menopause. There is no need to suffer or live with a reduced quality of life when there are many options for help available.
Set up a consultation with Dr. Angelina today and learn about the options that are available today, and let her help you determine the best type of treatment for your needs and circumstances. The symptoms of menopause are no joke, and sadly, many doctors do not have the training and just do not understand what you are going through. Dr. Angelina’s expertise ensures that you will be offered care that reflects the latest research, and she will take the time to review your symptoms and discuss every available option. With her personalized and compassionate care, you can find relief from hot flashes, night sweats, sleep issues, and other menopausal challenges, so you can feel normal and more like yourself again.
