Efficacy and safety of ursodeoxycholic acid in patients with intrahepatic cholestasis of pregnancy

Autores: Pařízek Antonín, Šimják Patrik, Černý Andrej, Šestinová Alena, Zdeňková Anna, Hill Martin, Dušková Michaela, et al

Resumen

Background and aims: Patients with intrahepatic cholestasis of pregnancy (ICP) benefit from ursodeoxycholic acid (UDCA)treatment. Since there is still certain reluctance to use UDCA in pregnant women, mainly due to warnings in the official SPC information in respective drug leaflets, our objective was to assess the efficacy and safety of UDCA during pregnancy. Material and methods: Our retrospective multicentric study was performed on 191 consecutive pregnant women with ICP treated with UDCA.Any maternal and/or fetal complications of the UDCA treatment were searched for; healthy pregnant women (n = 256) served as controls. Results: The UDCA treatment improved liver disease status in the majority of the affected women (86.1%). This treatment was well tolerated, with only negligible skin reactions (0.5%) and mild diarrhea (4.7%). No complications attributable to UDCA treatment were detected during the fetal life, delivery, or the early neonatal period. Conclusion: We confirmed the good efficacyand safety of UDCA treatment in pregnancy for both mothers and fetuses/neonates.

Palabras clave: Drug safety fetal complications intrahepatic cholestasis of pregnancy pregnancy ursodeoxycholic acid.

2016-10-21   |   207 visitas   |   Evalua este artículo 0 valoraciones

Vol. 15 Núm.5. Septiembre-Octubre 2016 Pags. 757-761 Ann Hepatol 2016; 15(5)