FDA warns of possible increased risk of death with somatropin

The FDA is informing consumers that results from the Santé Adulte GH Enfant (SAGhE) study, conducted in France, 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 (somatropin) 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.

The FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review. At this time, the FDA believes the benefits of recombinant growth hormone continue to outweigh its potential risks. Patients are advised not to stop taking recombinant human growth hormone without talking to their healthcare provider.

Recombinant human growth hormone, also known as somatropin [rDNA origin] injection, is marketed under the following brand names in the United States: Genotropin (from Pfizer), Humatrope (from Lilly), Norditropin (from Novo Nordisk), Nutropin and Nutropin AQ (from Genentech), Omnitrope (from Sandoz), Saizen (from EMD Serono), and Tev-Tropin (from Teva).

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm237969.htm.