The FDA ( Food and Drug Administration ) 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, 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.

A study conducted in France, the Santé Adulte GH Enfant ( SAGhE ) study, found that persons with certain kinds of short stature ( idiopathic growth hormone deficiency and idiopathic or gestational short stature ) treated with recombinant human growth hormone during childhood and who were followed over a long period of time, were at a small increased risk of death when compared to individuals in the general population of France.

Recombinant human growth hormone is a protein that is manufactured to be nearly identical to the main form of the naturally occurring human growth hormone. This hormone can stimulate tissue growth, linear growth, and protein, carbohydrate, lipid, and mineral metabolism. It has approved indications in both the adult and pediatric populations.

In the United States, recombinant human growth hormone is used in the pediatric population to treat short stature due to growth hormone deficiency ( including idiopathic 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, also known as Somatropin injection, is marketed under the following brand names in the United States: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin.

Source: FDA, 2011

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