Adverse events during growth hormone therapy.
The aim of this study was to ascertain the frequency of adverse events occuring during GH therapy in Australia and New Zealand since 1988. Data for children receiving GH has been collected prospectively on a national database, OZGROW, after informed consent has been given. Adverse events were coded by clinicians and have been analysed in relation to the nature of the event and the underlying diagnosis. There were 2922 subjects analysed, representing 9004 years of GH therapy. 151 subjects reported a total of 210 adverse events giving an overall frequency of 2.3% adverse events/patient treated year. Events that were probably related to GH therapy included peripheral oedema, injection site problems and increased frequency of kyphoscoliosis and slipped epiphysis in some groups. Adverse events were more frequent in growth hormone deficient children who had previously been treated for leukaemia, 8.1%, and in children previously treated for craniopharyngioma, 5.6%. A lower frequency was found for those with a diagnosis of idiopathic short stature, 1.6%, and familial short stature, 0.9%. Kyphoscoliosis was more frequently seen in Turner's syndrome, and slipped epiphyses in adolescent individuals with growth hormone deficiency, especially following treatment for leukaemia. There were no de novo tumours reported but the frequencies of recurrence/patient year for leukaemia, solid cranial tumours and craniopharyngioma were 1.1%, 2.2% and 3.8% respectively. A low frequency of adverse events has been reported on the OZGROW database but subsets of patients may be at increased risk of musculoskeletal abnormalities during GH therapy. The frequency of tumour recurrence during therapy is not different from known rates of recurrence in individuals not treated with GH.
Cowell
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Robert Vines Growth Research Centre, New Children's Hospital, Westmead NSW, Australia.
Dietsch
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D000293:Adolescent; D001315:Australia; D002318:Cardiovascular Diseases / Q000139:chemically induced; D002648:Child; D003397:Craniopharyngioma / Q000150:complications / Q000628:therapy; D004487:Edema / Q000139:chemically induced; D004839:Epiphyses, Slipped / Q000139:chemically induced; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy; D013006:Growth Hormone / Q000009:adverse effects* / Q000172:deficiency / Q000627:therapeutic use*; D006801:Humans; D007267:Injections / Q000009:adverse effects; D007738:Kyphosis / Q000139:chemically induced; D007938:Leukemia / Q000150:complications / Q000628:therapy; D008297:Male; D009422:Nervous System Diseases / Q000139:chemically induced; D009520:New Zealand; D010911:Pituitary Neoplasms / Q000150:complications / Q000628:therapy; D012008:Recurrence
D013006:Growth Hormone