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  • FDA Date: 12/22/2010

    Saizen (somatropin) FDA Drug Safety Communication

    Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and Possible Increased Risk of Death

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is informing the public that results from a study conducted in France--the Sante 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. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.

    At this time, FDA recommends that patients continue their recombinant human growth hormone treatment as prescribed by their healthcare provider and believes the benefits of recombinant growth hormone continue to outweigh its potential risks.

    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. 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 [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.

    Recombinant human growth hormone, also known as somatropin [rDNA origin] injection, is marketed under the following brand names in the United States: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin.

    View the full FDA Drug Safety Communication on FDA.gov