Animal studies of administration during organogenesis and lactation resulted in hydrocephaly in the offspring at a dose approximately 2 to 4 times the clinical dose. During organogenesis, doses approximately 0.1 to 1 times the clinical dose caused delayed skull ossification. There are no controlled data in human pregnancy.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated.

US FDA pregnancy category: X

Comments:
-During pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal changes; modifying this change with this drug offers no known benefit and may result in fetal harm.
-If pregnancy occurs, discontinue therapy.
-If this drug is used during pregnancy, or the patient becomes pregnant while on this drug, advise the patient of the potential harm to the fetus.

See references

Breastfeeding is not recommended during use of this drug.

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

Comments:
-The Centers for Disease Control and Prevention recommend that HIV infected mothers not breastfeed to avoid transmission of HIV infection to their infants.
-Because of both potential for HIV transmission and serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed.
-Administration of this drug to animals during organogenesis and lactation resulted in hydrocephaly in offspring at approximately 2 to 4 times the clinical dose.

See references