title: Safety of recombinant deoxyribonucleic acid-derived growth hormone: The National Cooperative Growth Study experience.
abstract: The National Cooperative Growth Study has monitored the safety of recombinant human GH (rhGH) since 1985. Data have been collected from more than 19,000 children representing over 47,000 patient-years of rhGH treatment. Children receiving GH for renal disease were more likely to develop problems such as intracranial hypertension than those with GH deficiency (P < 0.01). Children with idiopathic short stature were less likely to develop slipped capital femoral epiphysis than those with GH deficiency or Turner's syndrome (P < 0.01). There was no evidence of an increased recurrence of leukemia or central nervous system tumors. There were 3 new cases of leukemia in children without known risk factors for developing leukemia and 5 cases in children with known risk factors. Growth deceleration associated with high affinity, high capacity antibodies to GH was found in only 2 of 5039 subjects tested (0.04%). Major adverse events in association with rhGH treatment have been rare, and preexisting medical conditions such as renal insufficiency may affect their frequency.
authors.affiliation: Department of Pediatrics, State University of New York, Stony Brook 11794-8111, USA.
authors.forename: S L
authors.initials: SL
authors.lastname: Blethen
authors.forename: D B
authors.initials: DB
authors.lastname: Allen
authors.forename: D
authors.initials: D
authors.lastname: Graves
authors.forename: G
authors.initials: G
authors.lastname: August
authors.forename: T
authors.initials: T
authors.lastname: Moshang
authors.forename: R
authors.initials: R
authors.lastname: Rosenfeld
mesh_terms: D000293:Adolescent; D000328:Adult; D002349:Carpal Tunnel Syndrome / Q000139:chemically induced; D002648:Child; D004487:Edema / Q000139:chemically induced; D005260:Female; D013006:Growth Hormone / Q000009:adverse effects* / Q000172:deficiency / Q000627:therapeutic use; D006177:Gynecomastia / Q000139:chemically induced; D006801:Humans; D007938:Leukemia / Q000139:chemically induced; D008209:Lymphedema / Q000139:chemically induced; D008297:Male; D009369:Neoplasms / Q000139:chemically induced; D009506:Nevus / Q000473:pathology; D011559:Pseudotumor Cerebri / Q000139:chemically induced; D011994:Recombinant Proteins / Q000009:adverse effects* / Q000627:therapeutic use; D012008:Recurrence
chemical_list: D011994:Recombinant Proteins; D013006:Growth Hormone