Can ursodiol (ursodeoxycholic acid) be given to a pregnant patient with pruritus on the palms and soles and mildly elevated liver function tests?

From the Guidelines

Yes, ursodiol (ursodeoxycholic acid) can be given to a pregnant patient with pruritus on the palms and soles and mildly elevated liver function tests, as it is the recommended first-line treatment for intrahepatic cholestasis of pregnancy (ICP) 1.

Key Points

• The diagnosis of ICP is based on a serum bile acid level >10 mmol/L in the setting of pruritus, typically during the second or third trimester 1.
• Treatment with ursodeoxycholic acid should be offered in a total daily dose of 10–15 mg/kg 1.
• Ursodeoxycholic acid has been reported to improve pruritus, serum bile acid levels, and serum alanine aminotransferase levels, and may decrease adverse outcomes, including preterm birth and stillbirth 1.
• The typical starting dose for UDCA treatment is 10-15 mg/kg per day, which can be divided into 2 or 3 daily doses 1.
• Alternative drugs, such as S-adenosyl-methionine and cholestyramine, can be considered for patients who cannot take UDCA or who have continued symptoms on the maximum dosage 1.
• Delivery is advised to be based on serum total bile acid levels, with delivery at 36 weeks or at diagnosis if after 36 weeks for levels >100 mmol/L, and delivery between 36 and 39 weeks of gestation for levels <100 mmol/L 1.

From the FDA Drug Label

Pregnancy Reproduction studies have been performed in rats and rabbits with ursodiol doses up to 200-fold the therapeutic dose and have revealed no evidence of impaired fertility or harm to the fetus at doses of 20- to 100-fold the human dose in rats and at 5-fold the human dose (highest dose tested) in rabbits There have been no adequate and well-controlled studies of the use of ursodiol in pregnant women, but inadvertent exposure of 4 women to therapeutic doses of the drug in the first trimester of pregnancy during the ursodiol trials led to no evidence of effects on the fetus or newborn baby Although it seems unlikely, the possibility that ursodiol can cause fetal harm cannot be ruled out; hence, the drug is not recommended for use during pregnancy.

Ursodiol use in pregnant patients is not recommended due to the lack of adequate and well-controlled studies, and the possibility of fetal harm cannot be ruled out 2.

From the Research

Ursodiol (Ursodeoxycholic Acid) in Pregnancy

• Ursodiol (ursodeoxycholic acid) can be given to a pregnant patient with pruritus on the palms and soles and mildly elevated liver function tests, as it is the treatment of choice for intrahepatic cholestasis of pregnancy (ICP) 3, 4, 5, 6.
• ICP typically occurs during the last trimester of gestation and is characterized by pruritus, elevated bile acid levels, and mildly elevated liver function tests 3, 4, 6.
• Ursodeoxycholic acid has been shown to be effective in reducing pruritus and improving liver function tests in patients with ICP 3, 5, 6.
• The use of ursodeoxycholic acid in pregnancy has been associated with a decrease in bile acids and a significant decrease in serum transaminases 5.
• The available evidence suggests that ursodeoxycholic acid is the most effective therapy for ICP, improving pruritus and liver function tests without maternal or fetal toxicity 6.

Safety and Efficacy

• Studies have demonstrated the safety and efficacy of ursodeoxycholic acid in pregnant women with ICP, with significant relief in symptoms and improvement in liver function tests 3, 5, 6.
• Ursodeoxycholic acid has been shown to reduce serum bile acid concentrations and improve liver function tests in patients with ICP 5, 7.
• The use of ursodeoxycholic acid in pregnancy is associated with a reduced risk of fetal complications and improved pregnancy outcomes 3, 4, 6.

Diagnosis and Management

• The diagnosis of ICP is based on the presence of pruritus, elevated bile acid levels, and mildly elevated liver function tests 3, 4, 6.
• Ursodeoxycholic acid is the treatment of choice for ICP, and its use should be considered in pregnant women with pruritus and elevated liver function tests 3, 4, 5, 6.
• The management of ICP should include close monitoring of liver function tests, bile acid levels, and fetal well-being, as well as prompt delivery if necessary 3, 4, 6.