FDA cautions possible risk of death with recombinant human growth hormone

The US Food and Drug Administration (FDA) has announced a potential risk of death for persons treated with recombinant human growth hormone. The FDA is reviewing information and will publish new recommendations when its investigation is complete.

The Santé Adulte GH Enfan (SAGhE) study conducted in France has found that persons of short stature (idiopathic growth hormone deficiency and idiopathic or gestational short stature) treated with recombinant human growth hormone during childhood were at a small increased risk of death as adults compared with individuals in the general French population.

Recombinant human growth hormone is a manufactured protein that is nearly identical to naturally occurring human growth hormone. It stimulates tissue growth, height, and protein, carbohydrate, lipid, and mineral metabolism. The FDA has approved its use for both children and adults. In the pediatric population, recombinant human growth hormone is used to treat short stature caused by growth hormone deficiency, Turner syndrome, Noonan syndrome, Prader-Willi syndrome, short stature homeobox-containing gene (SHOX) deficiency, chronic renal insufficiency, idiopathic short stature, and children small for gestational age. Recombinant human growth hormone (somatropin injection) is marketed in the United States as Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin. At this time, the FDA says that the benefits of treatment with the drug continue to outweigh its potential risks.

FDA Drug Safety Communication: ongoing safety review of recombinant human growth hormone (somatropin) and possible increased risk of death [safety announcement]. December 22, 2010. www.fda.gov/Drugs/DrugSafety/ucm237773.htm. Accessed January 5, 2011.