FDA Drug Safety Communication: Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death
This safety review update is in follow-up to the FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death on 12/22/2010.
[8-4-2011] The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of recombinant human growth hormone (somatropin) and possible increased risk of death. In December 2010, FDA issued a Drug Safety Communication to inform the public that it was reviewing results from a study conducted in France—the Santé Adulte GH Enfant (SAGhE) study—and other available information on this potential risk. FDA has determined that, at this time, the evidence regarding recombinant human growth hormone and increased risk of death is inconclusive.
In its analysis of the SAGhE study, FDA identified a number of study design weaknesses that limit the interpretability of the study results. FDA also reviewed the medical literature,1-4 as well as reports from the Agency's Adverse Event Reporting System (AERS). These additional data sources did not provide evidence suggestive of a link between recombinant human growth hormone and an increased risk of death.
Healthcare professionals and patients should continue to prescribe and use recombinant human growth hormone according to the labeled recommendations.
FDA is continuing to review this safety issue and expects to receive additional data from the SAGhE study in Spring 2012. FDA will update the public when new information is available.
- Mills JL, Schonberger LB, Wysowski DK, Brown P, Durako SJ, Cox C, et al. Long-term mortality in the United States cohort of pituitary-derived growth hormone recipients. J Pediatr. 2004;144:430-6.
- Swerdlow AJ, Higgins CD, Adlard P, Preece MA. Risk of cancer in patients treated with human pituitary growth hormone in the UK, 1959-85: a cohort study. Lancet. 2002;360:273-7.
- Bell J, Parker KL, Swinford RD, Hoffman AR, Maneatis T, Lippe B. Long-term safety of recombinant human growth hormone in children. J Clin Endocrinol Metab. 2010;95:167-77.
- Barton JS, Cullen S, Hindmarsh PC, Brook CG, Preece MA. Growth hormone treatment in idiopathic short stature: a preliminary analysis of cardiovascular effects. Acta Paediatr Suppl. 1992;383:35-8.
FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death
Somatropin Information Comunicado de la FDA sobre la seguridad de los medicamentos: Actualización de la revisión de seguridad de la hormona de crecimiento humana recombinante (somatropina) y su posible aumento de riesgo de muerte