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Human growth hormone: increased risk of death in patients with idiopathic growth hormone deficiency and idiopathic or gestational short stature


A study conducted in France, SAGhE ( Santé Adulte GH Enfant ), found that patients with 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, height, 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.

The SAGhE study is reported to be a long-term epidemiological study. It was designed to assess the long-term mortality of patients treated with recombinant human growth hormone during childhood. The study population was based on a mandatory registry of patients in France who received recombinant human growth hormone treatment during childhood between 1985 and 1996 and whose vital status and cause of death was determined through September 2009.

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.

At this time, FDA believes the benefits of recombinant growth hormone continue to outweigh its potential risks.

Source: FDA, 2010

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