Published: June 2012

Somatropin - Is There an Increased Risk of Mortality?

Prescriber Update 33(2): 18-19
June 2012

Healthcare professionals are reminded that the recommended daily dose of somatropin should not be exceeded and somatropin must not be used when there is any evidence of activity of a tumour.

Medsafe recently conducted a review of somatropin following the publication of a paper showing increased risk of mortality in patients treated with somatropin. Medsafe concluded that the study had significant limitations and the benefits of somatropin treatment continue to outweigh the risks when used for approved indications and at the approved doses.

Somatropin is a recombinant human growth hormone that promotes growth during childhood and adolescence. In New Zealand, somatropin is indicated in children for growth disturbance due to insufficient secretion of growth hormones, Turner syndrome, chronic renal insufficiency and Prader-Willi syndrome.

A long-term population-based study in France of patients treated with somatropin during childhood found that patients receiving high doses of somatropin had a higher risk of mortality than patients on the low-dose regimen1. The study found that bone tumour-related and cerebrovascular disease-related mortality was increased.

The French study is part of a larger European study called the 'Safety and Appropriateness of Growth hormone treatments in Europe' (SAGhE).

A second paper from the SAGhE study did not support the observations of the French study.

The second SAGhE paper examined mortality and cause of death in patients treated with somatropin in Belgium, The Netherlands and Sweden2. Not a single case of death caused by cancer or cardiovascular disease was observed in the study.

Following the results from the French study, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) completed a review of the risks and benefits of somatropin3. The CHMP considered all available data on the safety of somatropin and concluded that the benefits of somatropin continue to outweigh the risks.

Medsafe supports the conclusions of the CHMP that the benefits of somatropin continue to outweigh the risks for the approved indications and doses.

  1. Carel JC, Ecosse E, Landier F, et al. 2012. Long-term mortality after recombinant growth hormone treatment for isolated growth hormone deficiency or childhood short stature: preliminary report of the French SAGhE study. Journal of Clinical Endocrinology and Metabolism 97: 416-25.
  2. Savendahl L, Maes M, Albertsson-Wikland K, et al. 2012. Long-term mortality and causes of death in isolated GHD, ISS, and SGA patients treated with recombinant growth hormone during childhood in Belgium, The Netherlands, and Sweden: preliminary report of 3 countries participating in the EU SAGhE study. Journal of Clinical Endocrinology and Metabolism 97: E213-7.
  3. European Medicines Agency. 2011. European Medicines Agency confirms positive benefit-risk balance of somatropin-containing medicines. Doc. Ref. EMA/CHMP/965945/2011 Rev.1. URL: library/Press_release/2011/12/WC500119189.pdf (accessed 18 May 2012).