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Implications for Practice and Policy

Arch Pediatr Adolesc Med. 2004;158:108-110.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The July 2003 approval of biosynthetic growth hormone (GH) by the Food and Drug Administration (FDA) for treating children with idiopathic short stature¹ has raised questions from physicians, parents, and the media about the appropriate use of this treatment and the effect of this decision on US children.^2-3 This editorial reviews the implications of the new GH indication for pediatric practice and policy.

BACKGROUND

Biosynthetic GH was originally approved by the FDA in 1985 only for short children with GH deficiency. Approval was then extended in 1993 to include children with short stature due to chronic renal insufficiency and in 1996 to include children with Turner syndrome. Even though these children do not have GH deficiency, evidence has shown that they have medical disorders that severely limit growth potential and that GH treatment can increase their heights. In 2000, GH was approved for the treatment of short stature in association with . . . [Full Text of this Article]

IMPACT IF GH IS USED IN STRICT ACCORDANCE WITH FDA INDICATION

IMPLICATIONS FOR PRACTICE AND POLICY
Leona Cuttler, MD
Department of Pediatrics, Division of Endocrinology
Rainbow Babies and Childrens Hospital
11100 Euclid Ave, Room 737
Cleveland, OH 44106
(e-mail: lxc15@po.cwru.edu)

J. B. Silvers, PhD
Cleveland

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