AU: Use is contraindicated
UK: Use should be avoided
US: Use only if clearly needed

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

Animal studies in rats have shown nonteratogenic skeletal deformities consisting of shortening, thickening, and bending of the humerus when dams received 15 times expected clinical exposure on days 17 to 22 of gestation and during lactation. Teratogenicity was not observed in rats or rabbits exposed to doses of 40 times and 0.8 times expected human exposure, respectively, throughout pregnancy. In humans, abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities. Most experts recommend insulin use during pregnancy to maintain blood glucose levels. 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 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.

See references

Measurable levels of this drug have been detected in the breast milk of rats resulting in lowered blood glucose levels in the pups. There is no information available on its excretion in human milk.

AU: Use is contraindicated
UK: Use is not recommended
US: 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: Yes

Comments: Blood glucose concentrations should be monitored in the breastfed infant.

See references