1. Write a brief overall summary of your findings.
The FDA website does indeed back up the broad claim that they will be removing black box warnings from HRT products for menopause. When this was first announced, 6 specific medications were listed as having their labels changes, Prometrium, Divigel, Cenestin, Enjuvia, Estring, and Bijuva. Examining the physician’s leaflet for these medications, it can be seen that these medications have usage outside of menopause. Specifically, Estring is listed as a treatment for estrogen deficiency and Prometrium is listed as a treatment for secondary amenorrhea.
A Fact Sheet from the Department of Health and Human services also states “The FDA recently approved a generic version of Premarin (conjugated estrogens) tablets, a complex mixture of estrogens used to treat various conditions related to menopause and hormone deficiencies.” This is further backed up by viewing the Premarin package insert, which lists it as a treatment for Hypogonadism, Castration or Primary Ovarian Failure and Palliative Care for Breast and Prostate Cancer.
As for HRT specifically for the use of gender transition, this is currently not an FDA approved use of the medication, meaning it does not appear as a use on any of the labels of these medications. However a paper from the Gender Affirming Health Program from the University of California San Francisco lists medications as used for feminizing hormone therapy, including Prometrium, one of the original 6 medications which had their black box label removed.
Overall, though these medications are primarily used for menopause, which is why the FDA article and the ABC News story focus on this topic, looking closer at the usage of these medications it can be seen that the drugs that this black box warning is being removed from have use cases outside of menopause.
2. What primary sources did you find (e.g., transcripts, videos of politician speeches, tweets from public figures, scientific studies)? For each source, write at least one or two sentences explaining what you learned. Include all links.
FDA announcement of removal of black box warning: https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy
FDA list of initial 6 medications which had the warning removed: https://www.fda.gov/drugs/drug-safety-and-availability/menopausal-hormone-therapies-updated-prescribing-information
Health and Human Services fact sheet listing further drugs with their warnings removed: https://www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-menopausal-hormone-replacement-therapy-products.html
Overview of feminizing hormone therapy from University of California San Francisco listing medications used in HRT treatment for gender affirming care: https://transcare.ucsf.edu/guidelines/feminizing-hormone-therapy
Drug Information Leaflets that list other use cases of their drugs outside of menopause:
Premarin: https://www.drugs.com/pro/premarin.html#s-34067-9
Estring: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020472s022lbl.pdf
Prometrium: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019781s026lbl.pdf
4. What potential biases or interests might each of your sources have?
All of these sources are primarily, either from government departments, scientific studies, or FDA approved drug fact sheets. I am fairly confident that these sources have little to no bias or interests other than public health.
5. What evidence supports the claim you are fact-checking?
My sources support the claim that both black box warnings are being removed from HRT products for menopause as well as the claim that these drugs have use cases outside of menopause.
6. What evidence undermines the claim you are fact-checking?
The FDA announcement specifically lists that they are removing the label specifically on products “for menopause”, however further examining the usage drugs it can be found that they are the same ones prescribed for other purposes besides their primary use of treatment for menopause.
