Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death

AUDIENCE: Pediatrics, Endocrinology

ISSUE: FDA is informing the public that results from a study conducted in France — the Santé Adulte GH Enfant (SAGhE) study — found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and idiopathic or gestational short stature) treated with recombinant human growth hormone during childhood and who were followed over a long period of time, were at a small increased risk of death when compared to individuals in the general population of France.