Studies in rats and rabbits with doses approximately 30 and 20-times the maximum recommended human dose (MRHD), respectively did not adversely affect developmental outcomes. At doses up to 100 times MRHD, an increase in the incidence of rib malformations was observed. Placental transfer was observed in pregnant rats and rabbits. There are no adequate and well-controlled studies in pregnancy women.

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 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.

Use is not recommended unless the benefit outweighs the risk to the fetus

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: Limited data available with this drug in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage; there are risks to the mother and fetus associated with poorly controlled diabetes during pregnancy.

Comments: In the US, Merck Sharp & Dohme Corporation maintains a pregnancy registry to monitor pregnancy outcomes of women exposed to this drug while pregnant; health care providers are encouraged to report any prenatal exposure (1-800-989-8999).

See references

This drug is secreted in the milk of lactating rats at milk to plasma ratio of 4:1. Pups of rats administered this drug at 1000 mg/kg/day from gestation day 6 through lactation day 20 showed reduced birth weight and postnatal weight gain (observed prior to and after weaning). No functional or behavioral toxicity was observed. Due to lack of human data, an alternate drug may be preferred.

US: Use caution
AU and UK: Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

The effects in the nursing infant are unknown

See references