Animal studies have revealed evidence of embryotoxicity, increased post-implantation loss, and decreased fetal body weight at maternotoxic IV doses of at least 2.5 times the maximum recommended human dose (MRHD). Small/absent gall bladders occurred in animal models given approximately 5 times the MRHD based on AUC values. Decreased epididymal sperm counts and decreased fertility occurred at doses at least 300 mcg/kg/day and 1000 mcg/kg/day, respectively. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

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: Unknown
Excreted into animal milk: Data not available

Comment: This drug could potentially harm a nursing infant.

See references