Adverse events during growth hormone therapy

Area of Science:

• Pediatric Endocrinology
• Pharmacovigilance
• Growth Hormone Therapy

Background:

• Growth hormone (GH) therapy is a critical treatment for various pediatric endocrine disorders.
• Monitoring adverse events (AEs) is essential for patient safety during long-term GH treatment.
• The OZGROW national database prospectively collects data on children receiving GH in Australia and New Zealand.

Purpose of the Study:

• To determine the frequency and types of adverse events associated with GH therapy in Australia and New Zealand since 1988.
• To identify patient subgroups at increased risk for specific adverse events during GH therapy.
• To assess the incidence of tumor recurrence in patients receiving GH therapy.

Main Methods:

• Analysis of prospectively collected data from the OZGROW national database (1988-present).
• Inclusion of 2922 subjects with a total of 9004 patient-treatment years.
• Adverse events coded by clinicians, analyzed by event type and underlying diagnosis.

Main Results:

• Overall AE frequency was 2.3% per patient-treated year (210 events in 151 subjects).
• Common AEs included peripheral edema, injection site issues, kyphoscoliosis, and slipped epiphysis.
• Higher AE rates observed in children previously treated for leukemia (8.1%) and craniopharyngioma (5.6%).
• Tumor recurrence rates during GH therapy were consistent with known rates for untreated patients.

Conclusions:

• GH therapy demonstrates a low overall frequency of adverse events in the studied population.
• Specific patient subsets, particularly those with prior leukemia or craniopharyngioma treatment, require closer monitoring for musculoskeletal adverse events.
• GH therapy does not appear to increase the risk of tumor recurrence.