Stephen J.LurieMD, PhD, Senior EditorIndividualAuthor
Copyright 2002 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.2002
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
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.
Jones KL. Treatment of Type 2 Diabetes Mellitus in Children. JAMA. 2002;287(6):716. doi:10.1001/jama.287.6.711