Can a pediatric patient with type 2 diabetes or obesity use Mounjaro (tirzepatide)?

Mounjaro (Tirzepatide) Use in Pediatric Patients

Mounjaro (tirzepatide) is NOT FDA-approved for use in children and should not be prescribed to pediatric patients outside of research trials. 1

Current FDA Approval Status

• Tirzepatide is approved by the FDA only for adults with type 2 diabetes, not for pediatric populations 1, 2
• The medication is commonly used off-label for obesity management in adults, but this brand name (Mounjaro) has no pediatric indication whatsoever 1
• Guidelines explicitly state that medications not FDA-approved for youth with type 2 diabetes should not be used outside of research trials 1

FDA-Approved Medications for Pediatric Type 2 Diabetes

For children aged 10 years and older with type 2 diabetes, only four medication classes are currently approved 3:

1. Metformin - First-line therapy for metabolically stable patients (A1C <8.5% without ketosis) 1
2. Insulin - Required for patients with ketoacidosis, marked hyperglycemia (glucose ≥250 mg/dL or A1C ≥8.5%), or when the distinction between type 1 and type 2 diabetes is unclear 1
3. Liraglutide (GLP-1 receptor agonist) - Approved for youth ≥10 years when metformin fails to achieve glycemic targets, contraindicated with personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 1, 3
4. Empagliflozin (SGLT2 inhibitor) - Approved for children aged 10-17 years, starting at 10 mg daily with potential escalation to 25 mg if A1C remains ≥7.0% after 12 weeks 4

Treatment Algorithm for Pediatric Type 2 Diabetes

For newly diagnosed patients without ketoacidosis:

• Start metformin as initial pharmacologic therapy, titrated to maximum dose of 2000 mg daily 1, 3
• Reassess A1C after 3 months 3
• If glycemic targets not met (A1C <7%), add either liraglutide or empagliflozin 4, 3

For patients presenting with severe hyperglycemia:

• Blood glucose ≥250 mg/dL or A1C ≥8.5%: initiate basal insulin while starting metformin 1
• Ketoacidosis present: treat with insulin until acidosis resolves, then add metformin 1

Pediatric Obesity Management (Without Diabetes)

For children with obesity but without type 2 diabetes, tirzepatide has no role 5:

• Intensive multicomponent behavioral therapy is the foundation: dietary modification, ≥150 minutes/week moderate-intensity physical activity, and behavioral counseling 5
• A multidisciplinary team (physician, diabetes educator, registered dietitian, psychologist/social worker) is essential 5
• For adolescents ≥12 years with severe obesity failing lifestyle interventions, orlistat is the only FDA-approved weight loss medication, though it has high rates of gastrointestinal adverse effects 1
• Metformin can be considered off-label for adolescents with obesity and insulin resistance, producing modest BMI reductions of approximately 3% 1, 5

Critical Caveats

• Do not use tirzepatide in children - there are no safety or efficacy data in pediatric populations, and guidelines explicitly prohibit use of non-approved medications outside research trials 1
• GLP-1 receptor agonists as a class should not be used for weight loss in non-diabetic youth 5
• Even for approved pediatric medications, long-term safety data beyond 4-12 months are limited 1
• Any pharmacotherapy in children must be combined with ongoing lifestyle interventions as medications are adjuncts, not replacements 5