Abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, neonatal morbidity, and mortality. It is important to achieve strict normoglycaemia during pregnancy. The use of insulin is generally recommended during pregnancy. There are no adequate and well-controlled studies in pregnant women.

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.

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.

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

Comments: Premenopausal anovulatory women may be at risk for pregnancy; these women should be informed of pregnancy risk.

US FDA pregnancy category: C
AU TGA 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 (rosiglitazone); Yes (metformin)
Excreted into animal milk: Yes (rosiglitazone); Yes (metformin)

Comments: The effects in the nursing infant are unknown.

See references