La Agencia Europea de Medicamentos (EMA), a través de su Comité de Evaluación de Riesgos en Farmacovigilancia, ha iniciado un análisis sobre los medicamentos que contienen finasterida y dutasterida, debido a reportes que sugieren una posible asociación con ideación suicida y trastornos del comportamiento.
Estos fármacos inhiben la enzima 5-alfa reductasa, reduciendo la conversión de testosterona en dihidrotestosterona, mecanismo por el cual se emplean en el tratamiento de la hiperplasia prostática benigna y, en el caso del finasteride, para la alopecia androgénica en hombres jóvenes. Ambos medicamentos tienen documentados efectos adversos psiquiátricos, incluyendo depresión, aunque la incidencia exacta de estos síntomas sigue sin estar claramente establecida. En respuesta a nuevos hallazgos, la ideación suicida ha sido incorporada como un posible efecto secundario de frecuencia desconocida en los prospectos de Propecia y Proscar.
EMA pide reforzar la vigilancia sobre el uso de estos medicamentos
Para minimizar los riesgos, la EMA ha reforzado las recomendaciones a los profesionales de la salud, instándolos a monitorear cualquier signo de alteración psiquiátrica en los pacientes y suspender el tratamiento si es necesario. Asimismo, se aconseja a los pacientes consultar con su médico ante cualquier síntoma de depresión o pensamientos suicidas.
La evaluación surge a partir de una petición de la Agencia Francesa de Medicamentos y abarcará todos los datos disponibles sobre estos fármacos, comercializados en la Unión Europea bajo nombres como Propecia, Proscar, Avodart y Finapil. En este contexto, los fabricantes de los medicamentos deberán proporcionar información detallada sobre:
- Advertencias y etiquetas en distintos países sobre efectos psiquiátricos.
Medidas implementadas para minimizar riesgos y su efectividad.
Evidencia científica sobre la posible relación entre estos medicamentos y la ideación suicida.
Factores de riesgo identificados, como dosis, duración del tratamiento y antecedentes psiquiátricos previos.
Propuestas para mejorar la seguridad de los pacientes y minimizar riesgos potenciales.
El resultado de esta revisión de la EMA será clave para determinar si estos medicamentos deben seguir en el mercado sin cambios, si requieren restricciones adicionales o, en el escenario más extremo, si deberían ser retirados del mercado.
*Este contenido fue creado por una plataforma de inteligencia artificial, revisado por el equipo periodístico de CONSULTORSALUD.
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