Animal studies have not been performed with this combination product. Sitagliptin administration to pregnant rats and rabbits during organogenesis did not adversely affect developmental outcomes at oral doses up to 30 and 20-times and maximum human recommended dose, respectively. Higher doses in rats increased the incidence of rib malformation and were also associated with maternal toxicity (approximately 100 times the clinical dose). Placental transfer of sitagliptin was observed these studies. Metformin administration to pregnant Sprague Dawley rats and rabbits at exposures representing 2 and 6-times a 2000 mg clinical dose did not cause adverse developmental effects, respectively. There are no adequate and well controlled studies in pregnant women with metformin-sitagliptin.

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.

Use only if clearly needed and benefit outweighs risk

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

Risk Summary: Limited data available are not sufficient to inform a drug-associated risk for major birth defects and miscarriage; published data with metformin have not reported a clear association. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.

Comments: There is a pregnancy exposure registry that monitors pregnancy outcomes; health providers are encouraged to report any prenatal exposure by calling 1-800-986-8999

See references

Benefit should outweigh risk

Excreted into human milk: Yes (Metformin, in small amounts); Unknown (sitagliptin)
Excreted into animal milk: Yes (metformin and sitagliptin)

Comments: Because there is no information on the use of sitagliptin during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

See references