SAFETY OF HUMAN GROWTH-HORMONE THERAPY - CURRENT TOPICS

Current data on patients treated with human growth hormone (GH) were a nalyzed for the following safety topics. New leukemia. Thirteen of 46 new cases of leukemia were in non-Japanese patients without risk facto rs for leukemia (compared with at least 13 new cases expected). A poss ible increased occurrence of leukemia with GH treatment appears to be limited to patients with risk factors. Nonleukemic extracranial neopla sms, The number of cases reported (10) does not differ significantly f rom the number expected. Acute pancreatitis, In five of the seven case s reported risk factors (renal failure, valproic acid use, insulin-dep endent diabetes mellitus) were present. The available data do not indi cate a clear cause-and-effect relation between GH therapy and pancreat itis, Prepubertal gynecomastia. Of 15 possible cases, two were puberta l, eight resolved or improved with continued GH therapy, and two resol ved with the cessation of GH therapy, An effect of GH treatment on pre pubertal gynecomastia remains unknown. Scoliosis. Scoliosis is reporte d in fewer than 1% of the patients in the National Cooperative Growth Study (general-population prevalence, 1.5% to 3%), Curvature progressi on can occur during growth acceleration, and a causal association with GH treatment is not substantiated, Pigmented nevi. Nevi growth may be increased with GH treatment, Biopsies have detected no neoplasia or p remalignant nevi transformations.