Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Dec 12.
doi: 10.1111/jgs.70256. Online ahead of print.

FDA Boxed Warning Removal on Menopause Hormone Therapy: What Geriatricians Should Know

Affiliations

FDA Boxed Warning Removal on Menopause Hormone Therapy: What Geriatricians Should Know

Sarina Hanfling et al. J Am Geriatr Soc. .

Abstract

A New Era for Menopause Hormone Therapy: Key Considerations for Geriatricians After FDA Boxed Warning Removal.

Keywords: genitourinary syndrome of menopause; menopause hormone therapy; vaginal estrogen.

PubMed Disclaimer

References

    1. K. K. Vesco, M. C. Leo, J. E. Bulkley, et al., “Improving Management of the Genitourinary Syndrome of Menopause: Evaluation of a Health System‐Based, Cluster‐Randomized Intervention,” American Journal of Obstetrics and Gynecology 224, no. 1 (2021): 62.e1–62.e13, https://doi.org/10.1016/j.ajog.2020.07.029.
    1. S. Cox, R. Nasseri, R. S. Ru bin, and Y. Santiago‐Lastra, “Genitourinary Syndrome of Menopause,” Medical Clinics of North America 107, no. 2 (2023): 357–369, https://doi.org/10.1016/j.mcna.2022.10.017.
    1. U.S. Food and Drug Administration, “FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women—July 17, 2025,” (2025), https://www.fda.gov/patients/fda‐expert‐panels/fda‐expert‐panel‐menopaus....
    1. U.S. Food and Drug Administration, “FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies,” FDA, (2025), https://www.fda.gov/drugs/drug‐safety‐and‐availability/fda‐requests‐labe....
    1. M. R. Kaufman, L. A. Ackerman, K. A. Amin, et al., “The AUA/SUFU/AUGS Guideline on Genitourinary Syndrome of Menopause,” Journal of Urology 214 (2025): 242–250, https://doi.org/10.1097/JU.0000000000004589.

LinkOut - more resources