The key findings, what they mean, and the context that matters.
THE HEADLINE TAKEAWAY80.7%
Awareness of the revised warning outpaced prescribing increases
Among surveyed Latin American physicians, 80.7% knew the revised FDA statement, while 18.7% reported increased menopausal hormone therapy prescribing.
This cross-sectional observational survey relied on self-report and cannot show that the revised statement caused practice changes; recall, social desirability and participation bias may affect the results.
See the evidence
Awareness of the revised FDA statement on MHT among surveyed Latin American physicians
80.7%
Blümel, Juan E et al.. Awareness and clinical impact of the revised FDA warning on menopausal hormone therapy among Latin American physicians. REDLINC XIV.. Menopause (New York, N.Y.). 2026.
Self-reported clinical impact of the revised FDA communication; the authors characterized the increase in prescribing as relatively modest
59.4% reported practice changes; 18.7% reported increased MHT prescribing
Blümel, Juan E et al.. Awareness and clinical impact of the revised FDA warning on menopausal hormone therapy among Latin American physicians. REDLINC XIV.. Menopause (New York, N.Y.). 2026.
Menopausal hormone therapy prescribing differed by race and ethnicity
48.7%lower relative odds
At one academic medical center, African American women had 48.7% lower relative odds of a menopausal hormone therapy prescription than White women. Asian and Hispanic women also had lower odds than White women.
These adjusted associations came from a retrospective observational study at one large academic medical center; they cannot explain the differences and may not generalize to other settings.
See the evidence
48.7% lower relative odds, calculated from AOR 0.513. This is not an absolute percentage-point difference.
Odds of an MHT prescription among African American women compared with White women
AOR 0.513 95% CI: 0.486-0.541
Rusk, Kimberly L et al.. From black box warning to wake-up call: menopausal hormone therapy prescribing patterns at a large academic medical center.. Menopause (New York, N.Y.). 2026.
Odds of an MHT prescription among Asian women compared with White women
AOR 0.760 95% CI: 0.688-0.838
Rusk, Kimberly L et al.. From black box warning to wake-up call: menopausal hormone therapy prescribing patterns at a large academic medical center.. Menopause (New York, N.Y.). 2026.
Odds of an MHT prescription among Hispanic women compared with White women
AOR 0.644 95% CI: 0.613-0.676
Rusk, Kimberly L et al.. From black box warning to wake-up call: menopausal hormone therapy prescribing patterns at a large academic medical center.. Menopause (New York, N.Y.). 2026.
Physicians reported changing risk discussions and education time
In the Latin American survey, 53.3% reported changing how they explained breast cancer risk, and 40.4% reported changing time spent on patient education and shared decision-making.
These are cross-sectional self-reports, not observed consultations or patient outcomes; recall, social desirability and participation bias may affect the results.
See the evidence
Self-reported changes in explaining breast cancer risk and time spent on patient education and shared decision-making
53.3%; 40.4%
Blümel, Juan E et al.. Awareness and clinical impact of the revised FDA warning on menopausal hormone therapy among Latin American physicians. REDLINC XIV.. Menopause (New York, N.Y.). 2026.
Local menopausal hormone therapy was the largest prescription category
At one academic medical center, local menopausal hormone therapy was the largest documented category, followed by systemic and then combination therapy.
This retrospective record review describes prescribing at a single center. It cannot establish why a type was chosen, and prescriptions obtained elsewhere may have been missed.
Rusk, Kimberly L et al.. From black box warning to wake-up call: menopausal hormone therapy prescribing patterns at a large academic medical center.. Menopause (New York, N.Y.). 2026.
Prescribing patterns varied by race and treatment category
African American, Hispanic and Asian women had lower adjusted odds of a menopausal hormone therapy prescription than White women at one center. Local menopausal hormone therapy was the largest documented category, followed by systemic and combination therapy.
This retrospective observational study used records from one large academic medical center; it cannot explain the differences, may miss prescriptions obtained elsewhere and may not generalize.
Study details & original results
Rusk, Kimberly L et al.. From black box warning to wake-up call: menopausal hormone therapy prescribing patterns at a large academic medical center.. Menopause (New York, N.Y.). 2026.
Odds of an MHT prescription among African American women compared with White women
AOR 0.513 95% CI: 0.486-0.541
Odds of an MHT prescription among Asian women compared with White women
AOR 0.760 95% CI: 0.688-0.838
Odds of an MHT prescription among Hispanic women compared with White women
Awareness exceeded reported increases in prescribing
80.7%
Among surveyed Latin American physicians, 80.7% knew the revised FDA statement; 59.4% reported practice changes and 18.7% reported increased menopausal hormone therapy prescribing. Changes involved breast cancer risk explanations and time spent on patient education and shared decision-making.
The cross-sectional observational survey was self-reported and subject to recall, social desirability and participation bias, so it cannot establish that the statement caused the changes.
Study details & original results
Blümel, Juan E et al.. Awareness and clinical impact of the revised FDA warning on menopausal hormone therapy among Latin American physicians. REDLINC XIV.. Menopause (New York, N.Y.). 2026.
Awareness of the revised FDA statement on MHT among surveyed Latin American physicians
80.7%
Self-reported clinical impact of the revised FDA communication; the authors characterized the increase in prescribing as relatively modest
59.4% reported practice changes; 18.7% reported increased MHT prescribing
Self-reported changes in explaining breast cancer risk and time spent on patient education and shared decision-making
Practice change tracked with protocols and preferences, not clearly with awareness
Standard hormone therapy protocol use, favorable perceptions of compounded bioidentical hormone therapy, and prioritizing patient preference were associated with more reported practice change. Regulatory awareness and menopause patient volume showed no clear association.
This cross-sectional survey involved obstetricians and gynecologists. The comparison groups for these estimates are not available in this summary; the reported intervals for awareness and patient volume included no difference.
Study details & original results
Cömert, Erhan Hüseyin et al.. Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists.. Menopause (New York, N.Y.). 2026.
Standard hormone therapy protocol use associated with reported practice change
aOR 1.50 95% CI: 1.05-2.14
Favorable perceptions of compounded bioidentical hormone therapy associated with reported practice change
aOR 1.85 95% CI: 1.35-2.54
Patient preference prioritization associated with reported practice change
aOR 1.21 95% CI: 1.06-1.38
Regulatory awareness not associated with self-reported change in clinical practice
aOR 0.89 95% CI: 0.69-1.14
Higher menopause patient volume associated with reported practice change
Dates show when findings were added here, not when papers were published. Study populations and comparisons differ.
WHEN YOU WANT TO GO DEEPERRead the product labelsEach document’s wording, version, source and date checked.
PRODUCT LABEL STATUS
What each product’s observed label document says about its boxed warning — read from the label itself and checked against the version published on DailyMed. A product’s status here is a fact about its label document on the date shown, not a statement about a regulatory decision.
How to read this table
In November 2025 the FDA announced it was initiating removal of boxed warnings from menopausal hormone therapy products, and it approved a first batch of six rewritten labels on 12 February 2026. Manufacturers submit labeling changes for FDA approval; the agency has published no timetable, so which products have updated labels changes over time — which is what this page tracks.
A boxed warning still being present does not mean a label is out of date. The endometrial-cancer boxed warning is retained on systemic estrogen-alone products, so a rewritten label for one of them still carries a boxed warning — covering endometrial cancer only. That is why this table reports what each warning covers rather than whether one exists.
14 of 16 tracked products verified against DailyMed on . See each row for its verification date or unresolved gap.
How this table is produced
Verified rows come directly from product label documents published by the National Library of Medicine (DailyMed). Automated checks match the pinned document identifier, product name and current version history before reading its boxed-warning section. Quoted warning headings are copied from that document; the status summaries are rule-based, not clinical assessments.
Label documents are not journal articles: they carry no DOI, are not peer reviewed, and cannot be retracted, so the citation and retraction checks that apply to the study findings elsewhere on this monitor do not apply here. When a product cannot be verified, the table says so instead of guessing. This page is AI-assembled and has not been reviewed by a clinician — it is not medical advice, and a drug’s label is the authority, not this summary of it.
See all 14 findingsOriginal results, comparisons and study details.
3 of 3 source groupsFindings stay together with their study.
SOURCE 026 findings
Rusk, Kimberly L et al.. From black box warning to wake-up call: menopausal hormone therapy prescribing patterns at a large academic medical center.. Menopause (New York, N.Y.). 2026.
Blümel, Juan E et al.. Awareness and clinical impact of the revised FDA warning on menopausal hormone therapy among Latin American physicians. REDLINC XIV.. Menopause (New York, N.Y.). 2026.
Cömert, Erhan Hüseyin et al.. Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists.. Menopause (New York, N.Y.). 2026.
Browse the 3 original sourcesThe full bibliography behind this monitor.
[1]
Cömert, Erhan Hüseyin et al.. Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists.. Menopause (New York, N.Y.). 2026.
Rusk, Kimberly L et al.. From black box warning to wake-up call: menopausal hormone therapy prescribing patterns at a large academic medical center.. Menopause (New York, N.Y.). 2026.
Blümel, Juan E et al.. Awareness and clinical impact of the revised FDA warning on menopausal hormone therapy among Latin American physicians. REDLINC XIV.. Menopause (New York, N.Y.). 2026.
Study findings are generated with AI assistance and have not been reviewed by a clinician. The date on each finding records when it was added to this monitor; it is not the publication date or a clinical review date.
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