---
title: "FDA Removes Boxed Warning for Menopausal Hormone Therapy: Key Points for Nurses"
id: "pubmed-42765755"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42765755"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42765755/"
doi: "10.1097/NSG.0000000000000411"
published_at: "2026-09-21T16:51:48.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# FDA Removes Boxed Warning for Menopausal Hormone Therapy: Key Points for Nurses
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42765755
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42765755/)
- **DOI:** [10.1097/NSG.0000000000000411](https://doi.org/10.1097%2FNSG.0000000000000411)
- **Published At:** 2026-09-21T16:51:48.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- In November 2025 the **Food and Drug Administration (FDA)** removed the **boxed warning** from menopausal hormone therapy products, signaling a major regulatory change in how risks and benefits are presented. - The decision reflects about **20 years of evolving evidence** since the Women's Health Initiative (WHI) randomized trials, which originally spurred widespread caution about hormone therapy. - The article reviews the evidence base that informed the FDA action, including the history and reinterpretation of WHI findings and subsequent research over two decades. - It clarifies current **indications** and **contraindications** for menopausal hormone therapy (MHT), as well as the regulatory rationale for changing labeling language. - There are practical implications for nursing practice: updated patient education, counseling about individualized risk–benefit decisions, and changes in how clinicians discuss MHT safety. - Nurses are advised to incorporate the revised labeling into shared decision-making conversations and to stay informed about guideline and label updates. - The article provides practical guidance for nurses counseling patients about menopause management options, emphasizing evidence-based, patient-centered care. - Supporting documents include the FDA press release (November 10, 2025) and multiple contemporary reviews and commentaries cited in the article's reference list. - Specific clinical recommendations, detailed risk estimates, and step-by-step counseling scripts were not fully reported in the source abstract and would require consulting the full article and cited references for operational details.
## Clinical Analysis & Structured Key Points
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Epub 2026 Sep 21. # Removal of boxed warning for menopausal hormone therapy: What nurses need to know [Michelle Dang](https://pubmed.ncbi.nlm.nih.gov/?term=Dang+M&cauthor_id=42765755)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42765755/#full-view-affiliation-1 "Michelle Dang is a Professor in the School of Nursing, California State University, Sacramento, Sacramento, CA.") Affiliations Expand ### Affiliation * 1 Michelle Dang is a Professor in the School of Nursing, California State University, Sacramento, Sacramento, CA. * PMID: **42765755** * DOI: [ 10.1097/NSG.0000000000000411 ](https://doi.org/10.1097/nsg.0000000000000411) Item in Clipboard Review # Removal of boxed warning for menopausal hormone therapy: What nurses need to know Michelle Dang. Nursing. 2026. Show details Display options Display options Format Abstract PubMed PMID Nursing Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Nursing%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Nursing%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42765755/) . 2026 Oct 1;56(10):34-38. doi: 10.1097/NSG.0000000000000411. Epub 2026 Sep 21. ### Author [Michelle Dang](https://pubmed.ncbi.nlm.nih.gov/?term=Dang+M&cauthor_id=42765755)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42765755/#short-view-affiliation-1 "Michelle Dang is a Professor in the School of Nursing, California State University, Sacramento, Sacramento, CA.") ### Affiliation * 1 Michelle Dang is a Professor in the School of Nursing, California State University, Sacramento, Sacramento, CA. * PMID: **42765755** * DOI: [ 10.1097/NSG.0000000000000411 ](https://doi.org/10.1097/nsg.0000000000000411) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract In November 2025, the Food and Drug Administration removed the boxed warning from menopausal hormone therapy products, marking a significant shift in how clinicians and patients understand the risk-benefit profile of these widely used medications. This change reflects 20 years of evolving evidence since the Women's Health Initiative study and has important implications for nursing practice. This article reviews the evidence behind this regulatory change, clarifies current indications and contraindications for hormone therapy, and provides practical guidance for nurses counseling patients about menopause management options. **Keywords:** FDA; boxed warning; menopausal hormone therapy (MHT); menopause; patient education. Copyright © 2026 Wolters Kluwer Health, LLC. All rights reserved. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Similar articles * [ The Food and Drug Administration boxed warning on menopausal hormone therapy: history, impact, and a regulatory inflection point in women's health. ](https://pubmed.ncbi.nlm.nih.gov/41979564/) Buchanan LA, Calkins MW, Kirk JK.Buchanan LA, et al.Menopause. 2026 Apr 14. doi: 10.1097/GME.0000000000002793. Online ahead of print.Menopause. 2026.PMID: 41979564 * [ Elimination of the Black Box Warning on Menopausal Hormone Therapy. ](https://pubmed.ncbi.nlm.nih.gov/41687116/) Sriprasert I, Hodis HN, Mack WJ, Rosser M, Evans ML, Xu X, Wright JD.Sriprasert I, et al.Obstet Gynecol. 2026 May 1;147(5):642-646. doi: 10.1097/AOG.0000000000006226. Epub 2026 Feb 13.Obstet Gynecol. 2026.PMID: 41687116 * [ Menopausal Hormone Therapy: A Narrative Review of Contemporary Evidence. ](https://pubmed.ncbi.nlm.nih.gov/42304170/) Finks SW, Cieri-Hutcherson NE, Vernon V, McBane SE.Finks SW, et al.Pharmacotherapy. 2026 Jul;46(7):e70178. doi: 10.1002/phar.70178.Pharmacotherapy. 2026.PMID: 42304170Review. * [ Advancing evidence-based regulation: Organization for the Study of Sex Differences and Society for Women's Health Research support FDA action on menopausal hormone therapy and encourage broader sex-informed drug label updates. ](https://pubmed.ncbi.nlm.nih.gov/41582174/) Cunningham RL, Galea LAM, Goulmamine S, Kararigas G, Schubert KG, Zuloaga KL, Ahmed SB.Cunningham RL, et al.Biol Sex Differ. 2026 Jan 25;17(1):30. doi: 10.1186/s13293-026-00838-4.Biol Sex Differ. 2026.PMID: 41582174Free PMC article.Review. * [ Menopausal Hormone Therapy and Cardiovascular Risk: Current Evidence and Treatment Recommendations. ](https://pubmed.ncbi.nlm.nih.gov/42693520/) Pillai AA, Mehta A, Godin SL, Frishman WH, Aronow WS.Pillai AA, et al.Cardiol Rev. 2026 Sep 4. doi: 10.1097/CRD.0000000000001464. Online ahead of print.Cardiol Rev. 2026.PMID: 42693520 [ See all similar articles ](https://pubmed.ncbi.nlm.nih.gov/?linkname=pubmed_pubmed&from_uid=42765755) ## References 1. 1. Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288(3):321–333. 2. 1. Lobo RA. Where are we 10 years after the Women's Health Initiative. J Clin Endocrinol Metab. 2013;98(5):1771–1780. 3. 1. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013;310(13):1353–1368. 4. 1. US Food and Drug Administration. HHS advances women's health, removes misleading FDA warnings on hormone replacement therapy [press release]. November 10, 2025. Accessed March 4, 2026. [https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-...](https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy) 5. 1. Makary MA, Nguyen CP, Høeg TB, Tidmarsh GF. Updated labeling for menopausal hormone therapy. JAMA. 2026;335(2):117–118. 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