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There are no adequate data on the use of ursodeoxycholic acid, particularly in the first trimester of pregnancy. Animal studies have provided evidence of teratogenic effect during the early phase of gestation. Axialith must not be used during pregnancy unless clearly necessary. Women of child-bearing potential should be treated only if they use reliable contraception; non-hormonal or low-estrogen oral contraceptive measures are recommended. However, in patients taking Axialith for dissolution of gallstones, effective non-hormonal contraception should be used, since hormonal oral contraceptives may increase biliary lithiasis. The possibility of a pregnancy must be excluded before beginning treatment.
It is not known whether ursodeoxycholic acid passes into breast milk. Therefore, Axialith should not be taken during lactation. If treatment with Axialith is necessary, the infant should be weaned.
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