Safety of recombinant deoxyribonucleic acid-derived growth hormone: The National Cooperative Growth Study experience

J Clin Endocrinol Metab. 1996 May;81(5):1704-10. doi: 10.1210/jcem.81.5.8626820.


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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Carpal Tunnel Syndrome / chemically induced
  • Child
  • Edema / chemically induced
  • Female
  • Growth Hormone / adverse effects*
  • Growth Hormone / deficiency
  • Growth Hormone / therapeutic use
  • Gynecomastia / chemically induced
  • Humans
  • Leukemia / chemically induced
  • Lymphedema / chemically induced
  • Male
  • Neoplasms / chemically induced
  • Nevus / pathology
  • Pseudotumor Cerebri / chemically induced
  • Recombinant Proteins / adverse effects*
  • Recombinant Proteins / therapeutic use
  • Recurrence


  • Recombinant Proteins
  • Growth Hormone