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February 13, 2002

Treatment of Type 2 Diabetes Mellitus in Children

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthor

JAMA. 2002;287(6):716. doi:10.1001/jama.287.6.711

To the Editor: In their Contempo Updates article about type 2 diabetes mellitus in children, Drs Ludwig and Ebbeling1 briefly discuss pharmacological agents and inaccurately state that "none have been approved for use in children by the Food and Drug Administration [FDA]."

In fact, after reviewing a supplemental application for use of metformin hydrochloride in children aged 10 to 16 years, the FDA concluded that this information demonstrated that the "drug product is safe and effective for use" in this age group. Final approval was granted on December 15, 2000. The package inserts have carried informational guidelines for use of this drug in children since January 2001. Other oral agents that have been used for management of type 2 diabetes in adults are currently undergoing clinical trials in children.