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

Antonín Parízek, Patrik Simják, Andrej Cerny?, Alena Sestinová, Anna Zdenková, Martin Hill, Michaela Dusková, Martin Procházka, Radovan Vlk, Zuzana Kokrdová, Michal Koucky?, Libor Vítek


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 efficacy and safety of UDCA treatment in pregnancy for both mothers and fetuses/neonates.

Key words. Drug safety, Fetal complications, Intrahepatic cholestasis of pregnancy, Pregnancy, Ursodeoxycholic acid

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The Official Journal of the Mexican Association of Hepatology, the Latin-American Association for the Study of the Liver and the Canadian Association for the Study of the Liver

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