Ursodeoxycholic acid (UDCA) is licensed for the treatment of gallstones and for primary biliary cirrhosis. Off-licence, it is used to treat intrahepatic cholestasis of pregnancy (ICP; also known as obstetric cholestasis). ICP is associated with an increased risk of adverse pregnancy outcome. Data on the use of UDCA needs to be interpreted in this context.
Since ICP typically occurs in late pregnancy, all studies of gestational UDCA use relate to exposures after the first trimester. Rates of miscarriage and infant congenital malformation following first trimester UDCA use are unknown.
There are currently no known associations between gestational UDCA exposure and increased rates of stillbirth, low birth weight or neurodevelopmental delay. There is some evidence of a reduction in stillbirth, preterm delivery, neonatal ICU admission and meconium aspiration following treatment of ICP with UDCA, however the data are limited and the benefit of treatment with UDCA is uncertain. Recent evidence would suggest that UDCA does not reduce perinatal morbidity and provides only a slight improvement in itching.
Other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.