A RISK-BENEFIT ASSESSMENT OF GROWTH-HORMONE USE IN CHILDREN

Citation
Sl. Blethen et Mh. Macgillivray, A RISK-BENEFIT ASSESSMENT OF GROWTH-HORMONE USE IN CHILDREN, Drug safety, 17(5), 1997, pp. 303-316
Citations number
127
Categorie Soggetti
Toxicology,"Pharmacology & Pharmacy","Public, Environmental & Occupation Heath
Journal title
ISSN journal
01145916
Volume
17
Issue
5
Year of publication
1997
Pages
303 - 316
Database
ISI
SICI code
0114-5916(1997)17:5<303:ARAOGU>2.0.ZU;2-S
Abstract
Growth hormone prepared by recombinant DNA technology (somatropin) has been commercially available for over Il years. More than 38000 childr en have been treated with different growth hormone products. While the best response to treatment occurs in children with severe growth horm one deficiency, therapy with growth hormone will increase the rate of statural growth in children with short stature of many different aetio logies. There are few studies of the effect of growth hormone treatmen t on final adult height, and the magnitude of this effect is harder to gauge, particularly in children with idiopathic short stature. Other benefits of growth hormone treatment in children include improvement i n psychosocial functioning and physiological parameters, such as bone mineral density. Adverse effects associated with growth hormone treatm ent have been relatively uncommon. Most of the safety data on growth h ormone have come from large postmarketing databases maintained by 2 ph armaceutical companies. The adverse event profile reported in children treated with growth hormone is different from that found in adults. P eripheral oedema and carpal tunnel syndrome, which are common in adult s treated with growth hormone and frequently result in treatment disco ntinuation, are rare in children. Intracranial hypertension is rare, b ut can occur in children with growth hormone deficiency, Ullrich-Tumer syndrome or renal insufficiency during the first 8 to 12, weeks after the start of growth hormone treatment; it has seldom been reported in adults with growth hormone deficiency. Children with growth hormone d eficiency, Ullrich-Turner syndrome or renal insufficiency are prone to develop slipped capital femoral epiphyses both before and during grow th hormone treatment. Therefore, limping and complaints of hip or knee pain should be carefully investigated.