Udiliv (Ursodeoxycholic Acid) in Pregnancy

Safety Profile

The American College of Gastroenterology recommends that UDCA is classified as FDA pregnancy category B, meaning animal studies have shown no fetal risk, though adequate human studies are limited, and no adverse maternal or fetal effects have been documented in multiple clinical trials and case series 3, 4

The European Association for the Study of the Liver recommends continuing UDCA throughout pregnancy in women with primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC) who were on treatment pre-conception, with a standard dosing of 15-20 mg/kg/day 1, 2, 3, 4, 6
The American Association for the Study of Liver Diseases suggests that UDCA is first-line treatment for symptomatic cholestasis developing during pregnancy, with an initial dose of 10 mg/kg/day and slowly increasing to 20 mg/kg/day as tolerated 5, 7

The National Institute for Health and Care Excellence recommends separating UDCA from bile acid sequestrants by at least 4 hours to maintain UDCA efficacy 1, 2, 3, 4, 6
The American Gastroenterological Association suggests that calcium-containing products should be separated by appropriate intervals, though specific timing is less critical than with bile acid sequestrants 8

The Society for Maternal-Fetal Medicine recommends monitoring serum bile acids repeatedly in those with worsening or new-onset pruritus, as higher levels correlate with reduced gestation length 1, 2, 6
The American College of Obstetricians and Gynecologists suggests assessing vitamin K status if the patient is also taking anion exchange resins or rifampicin, as these can exacerbate vitamin K deficiency 1, 2, 3, 4, 6

The European Association for the Study of the Liver recommends rifampicin 300-600 mg daily as second-line therapy if UDCA alone provides insufficient relief, considered safe in pregnancy with limited data 1, 2, 3, 6
The American Association for the Study of Liver Diseases suggests that anion exchange resins (cholestyramine 4-8 g/day or colestipol 5-10 g/day) can be used as an alternative, but must be given at least 4 hours after UDCA 1, 2, 3, 6