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.

 

·编者提示：12月20日，FDA发布公告称，来自在法国进行的一项名为SAGhE的研究发现，在患有某种类型的身材矮小（特发性生长激素缺乏和特发性或妊娠期生长迟缓）并在儿童时期曾接受过重组人生长激素（recombinant human growth hormone）治疗的的人群中，通过长期随访显示，当与普通人群中的个体患者相比时，前者的死亡风险会有小幅度地增加。FDA正在回顾性分析所有有关这一潜在风险的已有信息，并且一旦其调查完成，便会将所有新的建议与公众沟通。之前，欧洲药管局（EMA）也曾发布过类似的公告，具体信息可见本刊2010年第46期。