The US FDA is reviewing the safety of somatropin [recombinant human growth hormone] after results from the Sant� Adulte GH Enfant (SAGhE) study have suggested an increased risk of death among patients treated during childhood, particularly when high doses were used.
The SAGhE study* found that somatropin treatment was associated with a 30% increase in the risk of death compared with the general population. Specifically, data suggested that the increase in mortality was a result of bone tumours, cardiovascular disorders and cerebrovascular events (particularly subarachnoid and intracerebral haemorrhage). The FDA says it will review "all available information on this potential risk", after which it will make any new recommendations for the use of somatropin. In the meantime, the FDA recommends that patients continue their prescribed treatment.
In the US, somatropin is available as Genotropin, Humatrope, Nutropin, Nutropin AQ, Norditropin, Omnitrope, Saizen and Tev-Tropin.
* This study was based on a mandatory registry of patients in France treated with somatropin between 1985 and 1996.
[Reference]
1. FDA.FDA Drug Safety Communication: Ongoing safety review of recombinant human growth hormone (somatropin) and possible increased risk of death. Internet Document: [2 pages], 22 Dec 2010. Available from: URL: http://www.fda.gov. .
Editorial Comment: This decision by the FDA follows a similar decision made previously by the EMA, see Reactions 1332 p3.
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