“For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.” -FDA Commissioner Marty Makary, MD, MPH
By Leanna Coy, FNP
In February, the U.S. Food and Drug Administration (FDA) approved label changes to six hormone therapy medications used for the treatment of menopause symptoms. The products commonly known as hormone replacement therapy or HRT, have carried a “black box” warning regarding about risks since 2003 due to findings in the Women’s Health Initiative study. A black box warning is the agency’s most strict safety-warning given to a medication.
The label changes include removing risk statements related to cardiovascular disease, breast cancer, and probable dementia. The updates roll back years of concern regarding the use of these medications. Newer research has looked back at that landmark study and identified flaws in the original research. This led to 29 drug manufacturers submitting requests to the FDA for proposed changes to the black box warning.
Once very popular in reducing hot flash symptoms, use of HRT dropped off after the Women’s Health Study in 2002 due to reported concerns for increased risk of breast cancer and cardiovascular issues. The findings in that study were based on older formulations that are no longer widely used. Current formulations of the medications are considered safer for younger women and those within 10 years of entering menopause.
The decision to change the labeling comes after a long process. In July 2025 the FDA hosted an expert panel of Menopause and Hormone Replacement Therapy for Women to focus on reviewing the risks and benefits of HRT. This included reviewing the potential risks for breast cancer, uterine cancer, and cardiovascular disease versus the benefits for bone, genital, urinary, heart, and cognitive health.
The results from the expert panel’s finding led to the FDA beginning the process of removing the warning labels from HRT products in November 2025.
FDA Commissioner Marty Makary, MD, MPH said, “For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.”
The updated labeling impacts the four categories of HRT for menopausal women:
- Systemic combination estrogen and progestogen therapy, such as Bijuva
- Systemic estrogen-alone therapy, such as estradiol gel (Divigel), synthetic conjugates estrogens (Cenestin, Enjuvia)
- Systemic progestogen-alone therapy for women with a uterus using systemic estrogen, such as progesterone
- Topical vaginal estrogen therapy, such as estradiol cream or estradiol vaginal ring (Estring)
Health and Human Services Secretary Robert F. Kennedy, Jr. stated, “By removing these boxed warnings, we ensure that women receive accurate information about hormone therapy—free from exaggeration or fear. A healthcare system worthy of public trust tells the truth, updates its guidance as science evolves, and respects women’s ability to make informed choices about their own health.”
Women spend 1/3 of their life in menopause, which is the stage in life after menstrual periods end. The symptoms of menopause are caused by the loss of estrogen that occurs during this stage, which can greatly impact someone’s quality of life and work effect their work.
Common menopause symptoms include hot flashes, night sweats, brain fog, disrupted sleep, and mood changes. The loss of estrogen also triggers vaginal symptoms, known as genitourinary changes, including vaginal dryness and thinning tissue which often causes pain with sex, irritation, and frequent urinary tract infections. Decreased bone density with increased risk for a fracture occurs over time.
FDA approved HRT can help relieve and reduce these symptoms. Studies show women who begin HRT before age 60 have a reduced risk of fractures and death. Despite HRT growing in popularity once again, most women are still not using the treatment. An estimated 41 million women in the U.S. are living in menopause with only about 5% are actively receiving treatment.