Sitagliptin Use During Pregnancy
Sitagliptin (Januvia) should not be used during pregnancy as it lacks safety data and is not recommended by current diabetes management guidelines. 1
Safety Concerns and Guideline Recommendations
- Insulin is the only FDA-approved and preferred medication for treating diabetes during pregnancy due to its established safety profile and the fact that it does not cross the placenta 2, 3
- Current diabetes management guidelines from the American Diabetes Association (2025) do not include sitagliptin among medications discussed for use during pregnancy 1
- The guidelines specifically state that "other oral and non-insulin injectable glucose-lowering medications lack long-term safety data" for use during pregnancy 1
Recommended Medications for Diabetes in Pregnancy
First-Line Treatment
- Insulin is the gold standard and first-line pharmacological treatment for both gestational diabetes mellitus (GDM) and pre-existing diabetes during pregnancy 1
- Insulin does not cross the placenta and has a well-established safety profile in pregnancy 2, 3
Alternative Options (When Insulin Cannot Be Used)
- Metformin may be considered in specific circumstances when insulin cannot be used safely or effectively due to cost, language barriers, or cultural influences 1
- However, metformin crosses the placenta and has been associated with smaller neonates with accelerated postnatal growth and higher BMI in childhood 1
- Metformin should not be used in pregnant individuals with hypertension, preeclampsia, or those at risk for intrauterine growth restriction 1
Medications Contraindicated or Not Recommended During Pregnancy
- ACE inhibitors and angiotensin receptor blockers are contraindicated during pregnancy as they may cause fetal renal dysplasia, oligohydramnios, pulmonary hypoplasia, and intrauterine growth restriction 1
- Statins are generally not recommended during pregnancy, though they may be considered in specific high-risk situations through shared decision-making 1
- Sulfonylureas like glyburide cross the placenta and have been associated with increased neonatal hypoglycemia and macrosomia 1
- DPP-4 inhibitors like sitagliptin have insufficient safety data for use during pregnancy 1, 4
Clinical Implications and Management
- For women with diabetes who are planning pregnancy or who become pregnant while taking sitagliptin, the medication should be discontinued and replaced with insulin 1
- Preconception counseling is critical for women with diabetes to achieve optimal glycemic control before pregnancy 1
- All women with diabetes of childbearing potential should have regular discussions about family planning and effective contraception to prevent unplanned pregnancies while on medications that may be harmful during pregnancy 1
Postpartum Considerations
- After delivery, insulin sensitivity increases dramatically (approximately 34% lower insulin requirements than pre-pregnancy) 1
- For women with gestational diabetes, medications are usually not required in the postpartum period 1
- Sitagliptin has been studied in the postpartum period for women with prior GDM and impaired glucose regulation, but not during active pregnancy 5