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Obeticholic acid Pregnancy and Breastfeeding Warnings

Brand names: Ocaliva

Medically reviewed by Drugs.com. Last updated on Jun 12, 2023.

Obeticholic acid Pregnancy Warnings

Use should be avoided.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

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

Animal models have failed to show evidence of fetal harm or abnormalities at 6 to 13 times the maximum recommended human dose (MRHD) of 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.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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: Unknown
Excreted into animal milk: Unknown

Comment: The effects in the nursing infant are unknown.

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Cerner Multum, Inc. Australian Product Information.
  3. Product Information. Ocaliva (obeticholic acid). Intercept Pharmaceuticals, Inc. 2016.

References for breastfeeding information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Cerner Multum, Inc. Australian Product Information.
  3. Product Information. Ocaliva (obeticholic acid). Intercept Pharmaceuticals, Inc. 2016.

Further information

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

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