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Obeticholic acid Pregnancy and Breastfeeding Warnings

Obeticholic acid is also known as: Ocaliva

Medically reviewed on February 26, 2018

Obeticholic acid Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: Limited data available on use of this drug in pregnant women is not sufficient to inform a drug-related risk.

Animal models have failed to show evidence of fetal harm or abnormalities at MRHD 6 to 13 times 10 mg. Lower fetal body weight, increased early/late resorptions and decreased viable fetuses were observed at levels approaching maternal toxicity. There are limited controlled data in human pregnancy.

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 decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Obeticholic acid Breastfeeding Warnings

There are no data on the effects on milk production.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comment: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Ocaliva (obeticholic acid)." Intercept Pharmaceuticals, Inc., New York, NY.

References for breastfeeding information

  1. "Product Information. Ocaliva (obeticholic acid)." Intercept Pharmaceuticals, Inc., New York, NY.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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