What are the effects of tirzepatide (a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist) during pregnancy?

From the Guidelines

Tirzepatide is not recommended during pregnancy due to its potential risks to fetal development and lack of adequate studies in pregnant women. Women who are pregnant or planning to become pregnant should not use tirzepatide (brand names Mounjaro and Zepbound) 1. The medication's mechanism of action, affecting GLP-1 and GIP receptors, could potentially impact fetal development, and animal studies have shown potential risks. If a woman becomes pregnant while taking tirzepatide, she should contact her healthcare provider immediately to discuss discontinuation of the medication. The manufacturer recommends stopping tirzepatide at least 2 months before a planned pregnancy due to its long half-life in the body.

For women with type 2 diabetes who become pregnant, alternative medications like insulin are typically recommended as they have a better-established safety profile during pregnancy 1. Insulin should be used to manage type 1 diabetes in pregnancy and is preferred for the management of type 2 diabetes in pregnancy and gestational diabetes mellitus (GDM). The physiology of pregnancy necessitates frequent titration of insulin to match changing requirements and underscores the importance of daily and frequent blood glucose monitoring.

Some key points to consider:

• Tirzepatide has not been adequately studied in pregnant women, and its use during pregnancy is not recommended 1.
• Insulin is a safer alternative for managing diabetes during pregnancy, with a better-established safety profile 1.
• Women requiring medication for diabetes or weight management during pregnancy should work with their healthcare provider to find safer alternatives.
• The manufacturer recommends stopping tirzepatide at least 2 months before a planned pregnancy due to its long half-life in the body.
• GLP-1 receptor agonists, like tirzepatide, can decrease the effectiveness of oral contraceptives because of delayed gastric emptying; addition of barrier method is recommended for 4 weeks after initiation of a GLP-1 receptor agonist and after each dose increase 1.

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.

• Pregnancy Risk: The use of tirzepatide in pregnant women is not well-studied, and available data are insufficient to evaluate the risk of major birth defects, miscarriage, or other adverse outcomes.
• Animal Studies: Animal reproduction studies have shown that tirzepatide may cause fetal growth reductions and abnormalities at clinically relevant exposures.
• Clinical Considerations: Poorly controlled diabetes in pregnancy increases the risk of maternal and fetal complications, and the use of tirzepatide should be carefully considered in pregnant women.
• Recommendation: MOUNJARO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus 2.

From the Research

Tirzepatide and Pregnancy

There is no direct information available in the provided studies regarding the use of tirzepatide during pregnancy.

Available Information on Tirzepatide

• The studies provided focus on the efficacy and safety of tirzepatide in adults with type 2 diabetes and its potential use in managing obesity and cardiovascular risk factors 3, 4, 5, 6.
• Tirzepatide has been shown to be effective in reducing glycated haemoglobin and body weight, as well as improving cardiometabolic risk factors 3, 4, 5, 6.
• The renal effects and safety of tirzepatide have also been evaluated, suggesting a positive impact on urine albumin-to-creatinine ratio without detrimental effects on estimated glomerular filtration rate 7.

Limitations

• There are no research papers provided that directly address the use of tirzepatide during pregnancy.
• Further studies are needed to evaluate the safety and efficacy of tirzepatide in pregnant women.