Is Ursodeoxycholic Acid Safe in Breastfeeding Women?
Yes, ursodeoxycholic acid (UDCA) is safe for use during breastfeeding, as it is excreted into breast milk in only negligible amounts that do not contribute to the newborn bile acid pool.
Evidence Supporting Safety During Lactation
The most recent and highest quality guidelines strongly support UDCA safety during breastfeeding:
The 2023 EASL (European Association for the Study of the Liver) guidelines provide a strong recommendation that UDCA should be continued during breastfeeding in women with primary biliary cholangitis and primary sclerosing cholangitis 1.
The 2009 EASL guidelines explicitly state that UDCA is "not approved during breastfeeding, but likely to be safe for the baby, since significant amounts of UDCA cannot be found in milk during lactation" 1.
Direct Research Evidence on Breast Milk Concentrations
A 2022 study provides the most definitive evidence on UDCA excretion into breast milk 2:
Total bile acid concentrations in breast milk of UDCA-treated patients (receiving 500-1500 mg daily) were identical to untreated controls (3.2 ± 1 vs. 3.2 ± 0.2 µmol/L) 2.
UDCA concentrations in breast milk remained negligible at only 0.69 µmol/L, which does not contribute to the newborn bile acid pool 2.
No adverse effects were observed in any breastfed infants, and no deterioration in postnatal development occurred during routine 1-year follow-ups 2.
The study concluded that therapeutic administration of UDCA during lactation is safe for breastfed babies and should be included in guidelines for cholestatic disease therapy in breastfeeding mothers 2.
FDA Labeling Caution
The FDA drug label takes a more conservative stance, stating "It is not known whether ursodiol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ursodiol is administered to a nursing mother" 3.
However, this FDA caution predates the 2022 research demonstrating negligible breast milk concentrations and the 2023 EASL strong recommendation for continuation during breastfeeding 1, 2.
Clinical Recommendations
For women requiring UDCA therapy for cholestatic liver diseases (primary biliary cholangitis, primary sclerosing cholangitis, or intrahepatic cholestasis of pregnancy), breastfeeding should not be discouraged 1:
The typical therapeutic dose of 15-20 mg/kg/day for chronic cholestatic conditions is safe during lactation 1, 4.
No special monitoring of the breastfed infant is required beyond routine pediatric care 2.
The benefits of both UDCA therapy for maternal disease and breastfeeding for infant health clearly outweigh any theoretical risks 2.
Important Caveats
While UDCA is safe, obeticholic acid (a second-line agent for PBC) should NOT be used during breastfeeding due to lack of safety data 1.
If UDCA is co-administered with cholestyramine or other bile acid sequestrants, these medications should be separated by at least 4 hours to prevent interference with UDCA absorption 1, 4.