Rifabutin Pregnancy and Breastfeeding Warnings
Medically reviewed by Drugs.com. Last updated on Feb 16, 2023.
Rifabutin is also known as: Mycobutin
Rifabutin Pregnancy Warnings
Animal studies have revealed evidence of fetal skeletal variants at doses approximately equivalent to the recommended human dose based on body surface area. At doses reaching maternotoxicity, increased fetal skeletal anomalies and decreased fetal viability were reported. There are no controlled data in human pregnancy.
Animal models have revealed evidence of impaired spermatogenesis and effects on the gonads. There are no controlled data in humans.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
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.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-Some experts recommend: Use is contraindicated.
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.
Risk Summary: There are no adequate and well-controlled study data available on use of this drug in pregnant women to inform of a drug-related risk.
Comments:
-The use of rifampin (rifampicin) during the last few weeks of pregnancy has been associated with Vitamin K deficiency and postnatal hemorrhage in mothers and infants.
-Use of adequate methods of non-hormonal contraception should be encouraged.
Rifabutin Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-Some experts recommend: Use is contraindicated.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The US Centers for Disease Control and Prevention and other organizations state that breastfeeding should not be discouraged in patients taking this drug.
-The effects in the nursing infant are unknown.
See also
References for pregnancy information
- "Product Information. Mycobutin (rifabutin)." Pharmacia and Upjohn (2001):
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm" (2010):
References for breastfeeding information
- "Product Information. Mycobutin (rifabutin)." Pharmacia and Upjohn (2001):
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
- United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.