Urlyx/Urlyx 500 Use In Pregnancy & Lactation

Urlyx: Pregnancy: Pregnancy Category B: There are no adequate or well-controlled studies in pregnant women. The drug should be used during pregnancy only if clearly needed.
Lactation: It is not known whether ursodeoxycholic acid is excreted in human milk. Caution should be exercised when it is administered to a lactating mother.
Urlyx 500: Animal studies did not show an influence of UDCA on fertility. Human data on fertility effects following treatment with UDCA are not available.
Pregnancy: There are no or limited amounts of data from the use of UDCA in pregnant women. Studies in animals have shown reproductive toxicity during the early phase gestation. Ursodeoxycholic acid capsules must not be used during pregnancy unless clearly necessary.
Women of childbearing potential: Women of childbearing potential should be treated only if they use reliable contraception: non-hormonal contraceptives or low-oestrogen oral contraceptives are recommended. However, in patients taking Ursodeoxycholic acid 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.
Breastfeeding: According to few documented cases of breastfeeding women, milk levels of UDCA are very low and probably no adverse reactions are to be expected in breastfed infants.