Skip to Content

Cholic acid Pregnancy and Breastfeeding Warnings

Cholic acid is also known as: Cholbam

Cholic acid Pregnancy Warnings

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.

See references

Cholic acid Breastfeeding Warnings

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

References for pregnancy information

  1. "Product Information. Cholbam (cholic acid)." Manchester Pharmaceutical, Fort Collins, CO.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Cholbam (cholic acid)." Manchester Pharmaceutical, Fort Collins, CO.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide