FDA Reviewing Possible Increased Risk of Early Death with Somatropin Use

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On December 22, 2010, the Food and Drug Administration (FDA) issued a Drug Safety Communication to inform the public about results from the Santé Adulte GH Enfant (SAGhE) study conducted in France. The study found that persons with certain kinds of short stature treated with (recombinant human growth hormone (somatropin) during childhood 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, but at this time recommends that patients continue their recombinant human growth hormone treatment as prescribed by their healthcare provider.

The SAGhE study is a long-term epidemiological study 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.

The investigators report a 30% increased risk of death with recombinant human growth hormone therapy compared to the general population, with 93 observed deaths in the treated group versus 70 expected deaths in the general population in France. The data suggest an increase in mortality due to bone tumors and cardiovascular diseases including cerebrovascular events (mainly subarachnoid or intracerebral hemorrhage).

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Recombinant human growth hormone is a protein manufactured to be nearly identical to the main form of the naturally occurring human growth hormone.

The risk of death was reported to be increased when doses of recombinant growth hormone that are higher than what is normally prescribed for pediatric growth hormone deficiency were used.

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 approved doses in the United States for pediatric growth hormone deficiency are below 50 mcg/kg/day, except during puberty, when a higher dose regimen is approved for a limited duration of time. For short stature indications other than growth hormone deficiency, doses up to 69 mcg/kg/day (0.48 mg/kg/week) are currently approved.

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.

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