Is Trizpatide (tirzepatide) safe to use during pregnancy?

Tirzepatide in Pregnancy: Avoid Use and Transition to Insulin

Tirzepatide should not be used during pregnancy and must be discontinued immediately upon pregnancy recognition or suspicion, with transition to insulin as the gold standard treatment for diabetes management. 1

Immediate Management Upon Pregnancy Recognition

• Discontinue tirzepatide immediately when pregnancy is confirmed or suspected 1
• Transition to insulin therapy without delay, as insulin has established safety data and is the only medication recommended as first-line treatment for both gestational diabetes and pre-existing diabetes in pregnancy 1
• Insulin remains the gold standard with proven safety and efficacy for treating hyperglycemia during pregnancy 1

Why Tirzepatide Cannot Be Used in Pregnancy

Complete Absence of Human Safety Data

• No available data exist on tirzepatide use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes 2
• The teratogenic risk remains "undetermined" for the vast majority of newer medications, with 97.7% of drugs approved between 2000-2010 having undetermined pregnancy risk 3
• It takes an average of 27 years for a drug initially classified as "undetermined risk" to be assigned a more precise risk category 3

Medication Class Considerations

• GLP-1 receptor agonists (including the dual GLP-1/GIP agonist tirzepatide) lack long-term safety data in pregnancy and should not be used 1
• Other oral and non-insulin injectable glucose-lowering medications are similarly not recommended due to insufficient safety data 1, 4
• Even metformin and glyburide, which have more data, should not be used as first-line agents as both cross the placenta 1

Preconception Planning

• Ideally, achieve optimal glycemic control before conception through preconception counseling 4
• Women planning pregnancy while taking tirzepatide should transition to insulin before attempting conception 1, 4
• Target A1C <6% (42 mmol/mol) if achievable without significant hypoglycemia prior to and during pregnancy 1

Common Clinical Pitfalls to Avoid

• Do not continue tirzepatide "just until the first trimester ends" - discontinue immediately upon pregnancy recognition, as the highest teratogenic risk occurs during the first trimester, but safety is unknown throughout pregnancy 2
• Do not substitute with other GLP-1 receptor agonists (such as semaglutide or liraglutide) - these also lack adequate pregnancy safety data 1
• Do not delay insulin initiation while attempting to optimize other medications - insulin should be started immediately 1
• Do not use metformin or sulfonylureas as alternatives to insulin - while metformin may be considered in specific circumstances when insulin cannot be used safely, it crosses the placenta and has been associated with smaller neonates and accelerated postnatal growth 1, 4

Postpartum Considerations

• After delivery, insulin sensitivity increases dramatically (approximately 34% lower insulin requirements than pre-pregnancy) 4
• Reassess diabetes management postpartum, as medications may not be required if gestational diabetes was the indication 4
• If ongoing diabetes treatment is needed postpartum and breastfeeding is not planned, tirzepatide may be reconsidered at that time 2

Key Takeaway

There is no scenario in which tirzepatide use during pregnancy is appropriate based on current evidence. The complete absence of human safety data, combined with established safe alternatives (insulin), makes this a clear-cut clinical decision requiring immediate medication discontinuation and transition to insulin-based therapy. 1, 2