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

December 22, 2010

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. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.

BACKGROUND: Recombinant human growth hormone is a protein that is manufactured to be nearly identical to the main form of the naturally occurring human growth hormone. This hormone can stimulate tissue growth, linear growth (height), and protein, carbohydrate, lipid, and mineral metabolism. It has approved indications in both the adult and pediatric populations. In the United States, recombinant human growth hormone is used in the pediatric population to treat short stature due to growth hormone deficiency (including idiopathic [of unknown cause] growth hormone deficiency), Turner syndrome, Noonan syndrome, Prader-Willi syndrome, short stature homeobox-containing gene (SHOX) deficiency, chronic renal insufficiency, idiopathic short stature and children small for gestational age. Recombinant human growth hormone, also known as somatropin [rDNA origin] injection, is marketed under the following brand names in the United States: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin.

RECOMMENDATION: Do not stop taking recombinant human growth hormone without talking to your healthcare professional. At this time, FDA believes the benefits of recombinant growth hormone continue to outweigh its potential risks.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[12/22/2010 - Drug Safety Communication - FDA]

    

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