From the Guidelines
Ozempic (semaglutide) should not be used in patients under 18 years old due to the lack of FDA approval and insufficient clinical trial data in pediatric populations. The most recent guidelines from 2023, as stated in 1, recommend the use of glucagon-like peptide 1 receptor agonist therapy approved for youth with type 2 diabetes in children 10 years of age or older, but Ozempic is not specifically approved for this age group. According to 1 and 1, other medications like metformin and liraglutide have been approved for use in pediatric patients, but semaglutide lacks pediatric approval.
Key Considerations
- The medication is only approved for adults with type 2 diabetes or for weight management in adults with obesity or overweight with weight-related conditions.
- Some GLP-1 receptor agonists like liraglutide (Saxenda) have been approved for weight management in adolescents aged 12 and older, but semaglutide specifically lacks pediatric approval.
- Healthcare providers generally should not prescribe Ozempic to patients under 18 as safety and efficacy have not been established in this population.
Recommendations
- If treatment is needed for a child or adolescent with type 2 diabetes or obesity, other FDA-approved options for pediatric patients should be considered first.
- Any off-label use of Ozempic would require careful consideration of risks and benefits by a pediatric specialist, as stated in 1 and 1.
From the FDA Drug Label
It is not known if OZEMPIC 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
Ozempic Use in Patients Under 18 Years Old
- There are no research papers provided that directly address the use of Ozempic (semaglutide) in patients under 18 years old 2, 3, 4, 5, 6.
- The provided studies focus on lifestyle interventions, metformin, and their effects on type 2 diabetes prevention and management in adults, without mentioning the use of Ozempic in pediatric patients.
- None of the studies included in the evidence provide information on the safety and efficacy of Ozempic in patients under 18 years old.
- Therefore, it is not possible to determine the appropriateness of using Ozempic in patients under 18 years old based on the provided research papers.