Pharmacology and toxicology
Ursodeoxycholic acid (UDCA) is a naturally occurring bile acid that has been used to change the composition of bile in an effort to dissolve gallstones, and in the management of chronic cholestatic disorders. It also has been used as a therapy for intrahepatic cholestasis of pregnancy. Intrahepatic cholestasis of pregnancy is characterized by maternal pruritis with elevated serum bile acids and liver-function test abnormalities, and associated with an increased rate of fetal distress, stillbirth, premature deliveries, and perinatal morbidity. One study reported that only high levels of serum bile acids (= 40[imol/l) were associated with increased fetal risks (Glantz 2004). Ursodeoxycholic acid improves pruritis and biochemical abnormalities in patients with intrahepatic cholestasis of pregnancy (Roncaglia 2004, Reyes 2000, McDonald 1999). It is too early to say whether the use of UDCA improves fetal outcome in pregnancies affected by intrahepatic cholestasis of pregnancy, but several studies suggest better perinatal outcome (Zapata 2005, Palma 1997, Diaferia 1996). In a randomized study on 84 pregnant women with intrahepatic cholestasis of pregnancy who received either ursodeoxycholic acid or cholestyramine, pruritus was more effectively reduced by ursodeoxycholic acid than by cholestyramine, as were the biochemical abnormalities; babies were delivered significantly closer to term by patients treated with ursodeoxycholic acid than those treated with cholestyramine (Kondrackiene 2005).
As yet, there are no definitive studies on the use of ursodeoxycholic acid in early pregnancy, only for the second and third trimesters. There have not been reports of fetal damage following the treatment of a pregnant woman with intrahepatic cholestasis (Zapata 2005, Roncaglia 2004, Reyes 2000, McDonald 1999, Palma 1997, Diaferia 1996).
There is no documented experience with the use of chenodeoxy-cholic acid in pregnancy. In experimental animal studies, fetal liver damage has been noted after large maternal doses of this agent. This effect has not been described in humans as yet.
Recommendation. Ursodeoxycholic acid should be avoided during the first 3 months of pregnancy. If a patient becomes pregnant during treatment, the medication should be stopped, except when chronic use is necessary for primary biliary cirrhosis. Ursodeoxycholic acid can be used in the second and third trimesters for the treatment of intrahepatic cholestasis of pregnancy when indicated. Chenodeoxycholic acid should not be used during pregnancy. Treatment in the first trimester with bile acids does not require termination of the pregnancy or invasive diagnostic procedures.
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