Pediatrics Xagena

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Patients treated with recombinant human growth hormone during childhood: increased risk of long-term mortality

The long-term epidemiological study called SAGhE ( Santé Adulte GH Enfant ) was designed to assess the long-term mortality of patients treated with recombinant human growth hormone during childhood. This study was based on a mandatory registry of patients in France treated with recombinant growth hormone during childhood between 1985 and 1996.

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 ).

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. 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.

In summary, the SAGhE study reported an increased risk of death in patients who were treated with recombinant human growth hormone during childhood when compared to individuals in the general population of France.
FDA ( Food and Drug Administration ), at this time, recommends caution when interpreting the reported results. Additionally, FDA believes the benefits of recombinant growth hormone continue to outweigh the potential risks. ( Xagena )

Source: FDA, 2010