Growth Hormone Treatment May Increase Risk of Death, FDA Says

<"">Somatropin (recombinant human growth hormone) drugs may increase the risk of death, according to a Food & Drug Administration (FDA) alert issued last week. The FDA alert follows the publication of a French study that suggested growth hormone treatments could increase the risk of death in certain individuals who received the treatments as children.

In the US, somatropin is marketed under the following brand names: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin. Also known as recombinant human growth hormone, somatropin is a protein that is manufactured to be nearly identical to the main form of the naturally occurring human growth hormone. Somatropin can stimulate tissue growth, linear growth (height), and protein, carbohydrate, lipid, and mineral metabolism.

In the US, somatropin is used in the pediatric population to treat short stature due to growth hormone deficiency (including idiopathic [of unknown cause] 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.

According to the FDA alert, 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 somatropin 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.

The SAGhE study is reported to be a long-term epidemiological study. According to the FDA, 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 Somatropin treatment during childhood between 1985 and 1996 and whose vital status and cause of death was determined through September 2009.

According to the FDA, SAGhE saw a 30 percent increased risk for death with recombinant human growth hormone therapy compared with the general French population. There were 93 deaths in the treated group compared with 70 expected deaths. The risk for death appeared to be dose-related and usually occurred in individuals given doses higher than typically prescribed for pediatric growth hormone deficiency. The agency also said that the data suggested an increase in mortality due to bone tumors and cardiovascular diseases including cerebrovascular events (mainly subarachnoid or intracerebral hemorrhage).

At this time, the FDA recommends that patients continue their recombinant human growth hormone treatment as prescribed by their healthcare provider. The FDA is currently reviewing all available information on this potential risk and said it will communicate any new recommendations once it has completed its review.

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