From the FDA Drug Label
Available data with MOUNJARO use in pregnant women are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy. MOUNJARO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In pregnant rats administered tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities occurred at clinical exposure in maternal rats based on AUC. In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC.
The risks of becoming pregnant while taking Tirzepatide include:
- Fetal growth reductions and fetal abnormalities observed in animal studies at clinical exposures
- Potential risks to the fetus from exposure to tirzepatide during pregnancy
- Risks to the mother and fetus associated with poorly controlled diabetes in pregnancy, including diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. The use of Tirzepatide during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus 1.
From the Research
If you're taking tirzepatide and want to get pregnant, you should stop the medication at least 2 months before trying to conceive. Tirzepatide is not approved for use during pregnancy, and there is limited data on its effects on human pregnancy 2. The 2-month waiting period is recommended because tirzepatide has a long half-life in the body, meaning it takes time to be completely eliminated from your system. This medication works by mimicking hormones that regulate blood sugar and appetite, which could potentially affect fetal development. Animal studies have shown some reproductive concerns, though these don't always translate to human effects 3, 4, 5, 6.
Key Considerations
- Tirzepatide is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist used for the treatment of type 2 diabetes 3, 4, 5, 6, 2
- The medication has a low risk of hypoglycemia when used without insulin or insulin secretagogues and shows a generally similar safety profile to the GLP-1 receptor agonist class 3, 4, 5, 6, 2
- Common adverse events include mild to moderate gastrointestinal symptoms such as nausea, diarrhea, decreased appetite, and vomiting 3, 4, 5, 6, 2
Recommendations for Pregnancy
- If you're currently taking tirzepatide for type 2 diabetes and planning pregnancy, consult with your healthcare provider about switching to pregnancy-safe diabetes medications like insulin 2
- For those using it for weight management, your doctor can help develop an alternative pregnancy-safe weight management plan 2
- Always discuss family planning with your healthcare provider while on any medication to ensure the safest approach for both you and your potential pregnancy 2