ABSTRACT
OBJECTIVE: To assess the teratogenic risk associated with leflunomide during the first quarter of pregnancy, and to establish guidelines to minimize said risk. METHOD: Literature search using tertiary, secondary, and primary sources related to teratogenicity, including databases (MEDLINE and EMBASE) and specific webs. The information required for assessment, as well as for the establishment of criteria was collected. RESULTS: Leflunomide demonstrated an increased risk of fetal death and teratogenic effects in animals. No major or minor malformation cases have been reported in humans regarding leflunomide, which is classified within category X of fetal risk. A wash-out regimen may possibly reduce the risk for fetal harm. CONCLUSIONS: Conception scheduling or early pregnancy detection is required for better clinical counselling and the avoidance of unnecessary risk.
Subject(s)
Abnormalities, Drug-Induced/etiology , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Isoxazoles/adverse effects , Abnormalities, Drug-Induced/epidemiology , Animals , Female , Humans , Leflunomide , Pregnancy , Pregnancy Trimester, First , Risk AssessmentABSTRACT
Objetivo: Valorar el riesgo teratógeno de leflunomida duranteel primer trimestre de gestación y establecer una guía de actuaciónpara minimizar dicho riesgo.Método: Búsqueda bibliográfica en fuentes terciarias, secundariasy primarias relacionadas con teratogenia, incluyendo basesde datos (MEDLINE y EMBASE) y webs específicas. Se recoge lainformación necesaria para la valoración y para establecer los criteriosde la guía.Resultados: Leflunomida ha demostrado un incremento del riesgode muerte fetal y de efectos teratógenos en animales. No existencasos de malformación mayor o menor en humanos atribuidas a leflunomida.Se encuentra clasificada en la categoría X de riesgo fetal. Esposible que una pauta de lavado reduzca el riesgo de daño fetal.Conclusiones: Es necesario planificar la concepción o detectartempranamente el embarazo para recibir el mejor asesoramientoclínico y evitar así riesgos innecesarios
Objective: To assess the teratogenic risk associated withleflunomide during the first quarter of pregnancy, and to establishguidelines to minimize said risk.Method: Literature search using tertiary, secondary, andprimary sources related to teratogenicity, including databases(MEDLINE and EMBASE) and specific webs. The informationrequired for assessment, as well as for the establishment of criteriawas collected.Results: Leflunomide demonstrated an increased risk offetal death and teratogenic effects in animals. No major orminor malformation cases have been reported in humansregarding leflunomide, which is classified within category X offetal risk. A wash-out regimen may possibly reduce the risk forfetal harm.Conclusions: Conception scheduling or early pregnancydetection is required for better clinical counselling and theavoidance of unnecessary risk
