Somatropin, or recombinant human growth hormone, may not be associated with an increased risk of death, the Food and Drug Administration said Aug. 5.
The agency is continuing a safety review initiated in late 2010 following results from the ongoing, publicly funded, French-led Santé Adulte GH Enfant (SAGhE) cohort study designed to enroll 30,000 Europeans treated with somatropin as children.
The study is intended to shed light on the long-term health effects of childhood treatment with somatropin, including long-term mortality and cancer incidence.
The FDA has determined that the mortality evidence from the study is as yet inconclusive.
The agency explained in an update Aug. 4 that it had identified a number of weaknesses in the study "that limit the interpretability of the study results."
Additional literature reviews did not add to evidence of a link between recombinant human growth hormone and an increased risk of death, the FDA said.
"Healthcare professionals and patients should continue to prescribe and use recombinant human growth hormone according to the labeled recommendations," the agency said, adding that it would continue to review the issue following the receipt next spring of additional data from the French study.
The FDA said that it would update the public on somatropin "when new information is available."