Drug Safety and Availability > FDA Drug Safety Communication: Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death

The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of recombinant human growth hormone (somatropin) and possible increased risk of death. In December 2010, FDA issued a Drug Safety Communication to inform the public that it was reviewing results from a study conducted in France—the Santé Adulte GH Enfant (SAGhE) study—and other available information on this potential risk. FDA has determined that, at this time, the evidence regarding recombinant human growth hormone and increased risk of death is inconclusive.

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