Can I take sitagliptin while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary The limited available data with sitagliptin tablets 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 in pregnancy [see Clinical Considerations] . No adverse developmental effects were observed when sitagliptin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 30-times and 20-times, respectively, the 100 mg clinical dose, based on AUC [see Data] . The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a Hemoglobin A1c >7% and has been reported to be as high as 20 to 25% in women with a Hemoglobin A1c >10%. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Sitagliptin (oral), Golden State Medical Supply, Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

No information is available on the clinical use of sitagliptin during breastfeeding. Sitagliptin has a shorter half-life than most other dipeptidyl-peptidase IV inhibitors, so it might be a better choice among drugs in this class for nursing mothers. Monitoring of the breastfed infant's blood glucose is advisable during maternal therapy with sitagliptin.[1] However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

“Summary of Use during Lactation”, LactMed record “Sitagliptin” (LM748), quoted verbatim. Everything LactMed reports about Sitagliptin while breastfeeding.

8.2 Lactation Risk Summary There is no information regarding the presence of sitagliptin in human milk, the effects on the breastfed infant, or the effects on milk production. Sitagliptin is present in rat milk and therefore possibly present in human milk [see Data] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sitagliptin tablets and any potential adverse effects on the breastfed infant from sitagliptin tablets or from the underlying maternal condition. Data Sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4:1.

Prescribing label, section “8.2 Lactation”: Sitagliptin (oral), Golden State Medical Supply, Inc. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.