FDA recommends that patients continue their recombinant human growth hormone treatment as prescribed by their healthcare provider.
This recommendation has come based on the results from a study conducted in France—the Santé Adulte GH Enfant (SAGhE) study which 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. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.
