Safety has not been established during pregnancy; use only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Comments:
-Animal studies showed increased fetal resorptions, delayed parturition, fetal skeletal abnormalities and cardiac teratogenicity.
-This drug crosses the placenta in animal models, leading to degeneration of fetal pancreatic beta cells.
-This drug crosses the placental barrier and appears in cord blood; if given prior to delivery, neonatal hyperbilirubinemia, thrombocytopenia, altered carbohydrate metabolism, and other adverse effects may occur in the infant.
-Alopecia and hypertrichosis lanuginosa have occurred in infants when the mothers used this drug within the last 19 to 60 days of pregnancy.

Animal studies of oral administration showed increased fetal resorptions, delayed parturition, and fetal skeletal abnormalities; skeletal and cardiac teratogenicity were seen with intravenous administration. This drug crosses the placenta in animal models, leading to degeneration of fetal pancreatic beta cells. This drug crosses the placental barrier and appears in cord blood. There are no controlled data in human pregnancy.

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.

See references

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

Comments:
-There is no information regarding this drug on the presence in human milk.

See references