Mounjaro (Tirzepatide) Use in Pregnancy
No, pregnant women should not take Mounjaro (tirzepatide) during pregnancy. The FDA drug label explicitly states that pregnant women should "seek the advice of a health care professional before use," and there is no safety data supporting its use during pregnancy 1.
Evidence-Based Rationale
Lack of Safety Data
- Tirzepatide has not been studied in pregnant women, and the FDA labeling provides no specific pregnancy category or safety information beyond advising consultation with healthcare providers before use 1.
- Unlike medications with established pregnancy safety profiles (such as ondansetron, lorazepam, and dexamethasone for antiemetic use), tirzepatide lacks any clinical trial data or observational studies in pregnant populations 2.
Drug Class Considerations
- GLP-1 receptor agonists and dual GIP/GLP-1 agonists have unknown teratogenic and oncogenic potential in pregnancy 2.
- The 2025 multidisciplinary consensus statement on GLP-1 receptor agonists does not address pregnancy safety, focusing instead on perioperative management, which highlights the absence of established guidelines for use during pregnancy 2.
Clinical Decision Framework
- The principle that medications should only be used in pregnancy when benefits clearly outweigh risks applies here, but without any safety data, the risk-benefit calculation cannot favor tirzepatide use 2, 3.
- For diabetes management during pregnancy, there are well-established alternatives with known safety profiles that should be used instead 2.
Recommended Alternatives
For Type 2 Diabetes Management in Pregnancy
- Insulin remains the gold standard for diabetes management during pregnancy, with decades of safety data 2.
- Certain oral agents like metformin have been studied in pregnancy and may be considered under specific circumstances 2.
If Patient Becomes Pregnant While on Tirzepatide
- Discontinue tirzepatide immediately upon pregnancy confirmation 1.
- Transition to pregnancy-safe diabetes management with insulin as the primary therapy 2.
- Close monitoring of glycemic control is essential during the transition period 2.
Important Caveats
Weight Loss Indication
- Weight reduction is not recommended during pregnancy, even in obese women, as it can lead to reduced neonatal weight and slower infant growth 2.
- Tirzepatide's significant weight loss effects (demonstrated in clinical trials) make it particularly inappropriate for pregnancy 4, 5.