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Effectiveness of Recombinant Human Growth Hormone (rhGH) in the Treatment of Patients with Cystic Fibrosis

Slide: 31 of 37

Summary of Harms

This slide summarizes the potential harms data presented in the effectiveness review.

Study withdrawals were rare, suggesting that rhGH treatment was well tolerated. Injection site reactions and liver transaminase effects were rare.

Fasting blood glucose was elevated by rhGH treatment, but development of hyperglycemia or CFRD was rare.

IGF-I was elevated above the 100-ng/mL level that is thought to be associated with increased cancer risk. However, there is no consensus on the predictive value of this marker. There is insufficient evidence to evaluate cancer risk by using either other biomarkers such as IGFBP-3 or data from approved rhGH treatment regimens.