Awareness and clinical impact of the revised FDA warning on menopausal hormone therapy among Latin American physicians. REDLINC XIV

Objective: To evaluate Latin American physicians’ awareness regarding the recent revised statement of the US Food and Drug Administration (FDA) “black box warning” on menopausal hormone therapy (MHT) and to analyze its self-reported impact on clinical practice. Methods: A multicenter cross-sectional study was conducted in thirteen Latin American countries. Physicians caring for peri- and postmenopausal women completed an anonymous survey assessing awareness of the revised FDA communication, perceived clarity, self-reported impact on clinical practice, and MHT prescribing patterns. Bivariate analyses and multivariable logistic regression were performed. Results: A total of 2,166 physicians participated, mainly obstetrician-gynecologists (75.7%) and endocrinologists (9.0%). Overall, 80.7% were aware of the FDA revised statement. In addition, 90.5% considered that the previous warning had overestimated breast cancer risk, and 78.9% believed that the revised communication provides a more balanced view of risks and benefits. Changes in clinical practice were reported by 59.4% of participants, whereas 18.7% reported increased MHT prescribing. Furthermore, 53.3% modified the way they explain breast cancer risk, and 40.4% reported spending more time on patient education and shared decision-making. Physicians with ≤20 years of professional experience and those from specialties other than obstetrics and gynecology or endocrinology were more likely to report that the FDA revised statement would influence their therapeutic conduct. Conclusions: The revised FDA communication appears to have influenced Latin American physicians’ views and self-reported clinical practice, promoting a more balanced view of MHT and encouraging patient education and shared decision-making. However, the increase in MHT prescribing rates was relatively modest, and overall findings should be interpreted cautiously given the cross-sectional design, self-reported nature of the data, and potential selection bias.

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Publication Details

Journal
Menopause The Journal of The North American Menopause Society
Published
2026-10-06
DOI
https://doi.org/10.1097/gme.0000000000002893
Primary Topic
Menopause: Health Impacts and Treatments
Type
article
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article

Awareness and clinical impact of the revised FDA warning on menopausal hormone therapy among Latin American physicians. REDLINC XIV

Patricio Barriga, Carlos Escalante, Maribel Dextre, Gabriela Ayala et al.
Menopause The Journal of The North American Menopause Society
Menopause: Health Impacts and Treatments
article

Awareness and clinical impact of the revised FDA warning on menopausal hormone therapy among Latin American physicians. REDLINC XIV

Patricio Barriga, Carlos Escalante, Maribel Dextre, Gabriela Ayala, Flory Morera, Eliana Ojeda, Marcela López, Juan Enrique Blümel, Hugo Salinas, Luis Rolando Hernández, María S. Vallejo, María Antonia Basavilvazo, Doris Rodríguez-Vidal, José Mendes Aldrighi, Sócrates Aedo, Rogério Bonassi Machado, Peter A. Chedraui, Daysi Navarro-Despaigne, P. Carpintero, Humberto Izaguirre, Ana Lúcia Ribeiro Valadares, Claudia Rey, Carlos Salinas, Lúcia Costa‐Paiva, Mónica Ñañez, Ascanio Bencosme, Konstantinos Tserotas, Nilson Roberto de Melo, Eugenio Arteaga, Erik González, Juan P. Matzumura-Kasano, Hugo Florencio Gutiérrez-Crespo, Gladys Isabel Fernández, Marcio AH Rodrigues, Ircania García, Félix Ayala, Marcela S. Aguirre, Alejandra Schüle, José Moreno, Mabel Martino, Greta Solis
article en

Abstract

Objective: To evaluate Latin American physicians’ awareness regarding the recent revised statement of the US Food and Drug Administration (FDA) “black box warning” on menopausal hormone therapy (MHT) and to analyze its self-reported impact on clinical practice. Methods: A multicenter cross-sectional study was conducted in thirteen Latin American countries. Physicians caring for peri- and postmenopausal women completed an anonymous survey assessing awareness of the revised FDA communication, perceived clarity, self-reported impact on clinical practice, and MHT prescribing patterns. Bivariate analyses and multivariable logistic regression were performed. Results: A total of 2,166 physicians participated, mainly obstetrician-gynecologists (75.7%) and endocrinologists (9.0%). Overall, 80.7% were aware of the FDA revised statement. In addition, 90.5% considered that the previous warning had overestimated breast cancer risk, and 78.9% believed that the revised communication provides a more balanced view of risks and benefits. Changes in clinical practice were reported by 59.4% of participants, whereas 18.7% reported increased MHT prescribing. Furthermore, 53.3% modified the way they explain breast cancer risk, and 40.4% reported spending more time on patient education and shared decision-making. Physicians with ≤20 years of professional experience and those from specialties other than obstetrics and gynecology or endocrinology were more likely to report that the FDA revised statement would influence their therapeutic conduct. Conclusions: The revised FDA communication appears to have influenced Latin American physicians’ views and self-reported clinical practice, promoting a more balanced view of MHT and encouraging patient education and shared decision-making. However, the increase in MHT prescribing rates was relatively modest, and overall findings should be interpreted cautiously given the cross-sectional design, self-reported nature of the data, and potential selection bias.

Menopause The Journal of The North American Menopause Society
Universidade Federal de Minas Gerais (BR), AOL (United States) (US), Pontificia Universidad Católica Madre y Maestra (DO), Pontificia Universidad Católica de Chile (CL), Mexican Social Security Institute (MX), Universidade de São Paulo (BR), Universidade Estadual de Campinas (UNICAMP) (BR), National University of San Marcos (PE), University of Havana (CU), Clínica Alemana (CL), Universidad Espíritu Santo (EC), Universidad de Costa Rica (CR), Hospital Clínico Universitario de Caracas (VE), Finis Terrae University (CL), Instituto Universitario Italiano de Rosario (AR), Hospital de Clínicas "José de San Martín" (AR), Perinatal Institute (GB), Hospital Clínico de la Universidad de Chile (CL), Instituto Tecnológico de Buenos Aires (ITBA) (AR), Servicio Diabetología Hospital Córdoba (AR), Universidad Andina del Cusco (PE), Faculdade de Medicina de Jundiaí (BR), Hospital de Clínicas da Unicamp (BR), Hospital Metropolitano (EC), Hospital Juárez de México (MX), Cordoba University (US), University of Chile (CL)
Openalex Percentile: Top 10%
Menopause: Health Impacts and Treatments
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