Deoxycholic acid Pregnancy and Breastfeeding Warnings
Brand names: Kybella
Medically reviewed by Drugs.com. Last updated on Sep 13, 2023.
Deoxycholic acid Pregnancy Warnings
The background risk of major birth defects and miscarriage for the indicated population is unknown. Animal studies did not reveal fetal harm or fertility impairment in rats administered doses up to 5-fold higher than the maximum recommended human dose (MRHD), but missing intermediate lung lobe was noted in rabbits at all dose levels tested including the lowest dose which is 2-fold higher than the MRHD. These effects may be related to maternal toxicity, which was also seen at all dose levels tested. There are no 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.
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned
Deoxycholic acid Breastfeeding Warnings
Safety has not been established; the benefits of breastfeeding should be considered along with the mother's need for this drug and any potential adverse effects on the breastfed child.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: The effects in the nursing infant are unknown.
See also
References for pregnancy information
- Product Information. Kybella (deoxycholic acid). Kythera Biopharmaceuticals, Inc. 2015.
References for breastfeeding information
- Product Information. Kybella (deoxycholic acid). Kythera Biopharmaceuticals, Inc. 2015.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
