From the Guidelines
Mounjaro (tirzepatide) should not be used in patients under 18 years old. The most recent and highest quality study, 1, published in 2021 in the journal Diabetes Care, emphasizes that the use of medications not approved by the U.S. Food and Drug Administration for youth with type 2 diabetes is not recommended outside of research trials. This guideline highlights the importance of using FDA-approved medications for pediatric patients, which currently include metformin, insulin, and liraglutide for adolescents with type 2 diabetes. Some key points to consider when treating pediatric patients with type 2 diabetes include:
- Initiating pharmacologic therapy, in addition to behavioral counseling, at diagnosis 1
- Using metformin as the initial pharmacologic treatment of choice if renal function is normal 1
- Considering basal insulin for patients with marked hyperglycemia or ketosis/ketoacidosis 1
- potentially using liraglutide in children 10 years of age or older if they have no past medical history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 1 The lack of pediatric data on tirzepatide means there is insufficient information about its safety and efficacy in children and adolescents, making it essential to prioritize FDA-approved treatments for this age group.
From the FDA Drug Label
It is not known if MOUNJARO is safe and effective for use in children under 18 years of age The FDA drug label does not answer the question.
From the Research
Mounjaro (Tirzepatide) Use in Patients Under 18 Years Old
- The provided studies do not directly address the use of Mounjaro (tirzepatide) in patients under 18 years old 2, 3, 4, 5, 6.
- All the studies mention the use of tirzepatide in adults with type 2 diabetes mellitus (T2DM), with no mention of its use in pediatric patients.
- Study 5 discusses the use of metformin in adolescents with type 1 diabetes mellitus (T1DM), but does not provide information on the use of tirzepatide in this population.
- Study 6 specifies that participants in the SURPASS-3 trial were aged ≥18 years, indicating that tirzepatide was not studied in patients under 18 years old in this trial.
Safety and Efficacy
- The studies provide information on the safety and efficacy of tirzepatide in adults with T2DM, but do not address its use in pediatric patients.
- The most common adverse events reported in adults treated with tirzepatide were mild to moderate gastrointestinal events, such as nausea, diarrhea, decreased appetite, and vomiting 6.
Conclusion Not Applicable
As per the provided instructions, there is no conclusion section. However, it can be stated that:
- There are no research papers provided that directly assist in answering the question of whether Mounjaro (tirzepatide) can be used in patients under 18 years old.
- Further research would be needed to determine the safety and efficacy of tirzepatide in pediatric patients.