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Medicamentos recetados en el embarazo y las malformaciones congénitas: un estudio de detección de seguridad basado en
Anne Broe1,2,3, Anton Pottegård4, Trine Munk-Olsen4,5
1Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark.
Pharmacoepidemiology and drug safety
|August 27, 2025
Resumen
Este estudio encontró más de 100 medicamentos recetados seguros para el primer trimestre de embarazo, ofreciendo tranquilidad para las futuras madres. Sin embargo, identificó riesgos potenciales con el clopidogrel y la liraglutida, que requieren una investigación adicional.
Área de la Ciencia:
- Obstetricia y ginecología
- Farmacología clínica
- Salud pública
Sus antecedentes:
- El consumo de drogas durante el embarazo plantea desafíos debido a los posibles daños al feto.
- Las preocupaciones históricas, como la tragedia de la talidomida, ponen de relieve la necesidad de datos de seguridad.
- La información precisa es crucial para aconsejar a las mujeres embarazadas sobre los medicamentos recetados.
Objetivo del estudio:
- Evaluar el riesgo de malformaciones congénitas graves por exposición a medicamentos recetados durante el primer trimestre.
- Proporcionar orientación basada en la evidencia para el uso de medicamentos en poblaciones embarazadas.
Principales métodos:
- Estudio de cohorte basado en la población en Dinamarca (2004-2017).
- Registros nacionales de salud vinculados para obtener datos completos sobre nacimientos vivos y exposición a drogas.
- Análisis de regresión logística para comparar los resultados entre los lactantes expuestos y no expuestos.
Principales resultados:
- Más de 100 fármacos no mostraron un mayor riesgo de malformaciones congénitas importantes.
- Se asociaron 31 fármacos con un mayor riesgo (ratio de probabilidades ajustado [aOR] ≥ 2,0).
- La insulina fue el único fármaco entre los prescritos a ≥ 1000 mujeres con aOR ≥ 2,0 para malformaciones generales.
Conclusiones:
- Los amplios datos confirman más de 100 asociaciones nulas entre la exposición al fármaco en el primer trimestre y las malformaciones congénitas importantes.
- Proporciona tranquilidad a las mujeres embarazadas y apoya la toma de decisiones compartida con respecto a la medicación.
- Se identificó clopidogrel y liraglutida como teratógenos potenciales que requieren más investigación.
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