This drug has been used without apparent harmful effects

US FDA pregnancy category: Not assigned

Comment: Laboratory monitoring should increase during pregnancy

Animal studies have not shown teratogenicity or fetal toxicity. These studies have not been conducted to the same level of detail as cholic acid is a physiological substance in animals and humans. There are no controlled data in human pregnancy. Limited data in less than 20 human pregnancy outcomes have shown no adverse reactions to cholic acid and resulted in normal, healthy children.

To monitor outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling COCOA Registry (ChOlbam: Child and mOther's HeAlth 1-844-20C-OCOA or 1-844-202-6262.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

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Use is considered acceptable

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown; however no harmful effects are anticipated

No studies are available evaluating the presence of this drug in human milk, its effects on the breastfed infant, or its effects on milk production. Endogenous cholic acid is present in human milk. Use of this drug during lactation will be determined by considering the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug against any potential adverse reactions on the breastfed infant and the mother's underlying condition.

See references