SAFETY OF RECOMBINANT DEOXYRIBONUCLEIC ACID-DERIVED GROWTH-HORMONE - THE NATIONAL COOPERATIVE GROWTH STUDY EXPERIENCE

The National Cooperative Growth Study has monitored the safety of reco mbinant human GH (rhGH) since 1985. Data have been collected from more than 19,000 children representing over 47,000 patient-years of rhGH t reatment. 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 les s likely to develop slipped capital femoral epiphysis than those with GH deficiency or Turner's syndrome (P < 0.01). There was no evidence o f an increased recurrence of leukemia or central nervous system tumors . There were 3 new cases of leukemia in children without known risk fa ctors for developing leukemia and 5 cases in children with known risk factors. Growth deceleration associated with high affinity, high capac ity 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 pre-existing medical conditions such as renal insufficiency may affect their frequency.