Safety Alerts & Recalls

What does this mean?

At this time, FDA believes the benefits of recombinant growth hormone continue to outweigh its potential risks. The FDA recommends that patients continue their recombinant human growth hormone treatment as prescribed by their healthcare provider. If you have concerns about your recombinant human growth hormone, please follow up with your healthcare provider.

Recombinant Human Growth Hormone (Somatropin): FDA Conducting Ongoing Safety Review

The U.S. Food and Drug Administration (FDA) is informing the public that results from a study conducted in France found that persons with certain kinds of 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. This study, the Sante Adulte GH Enfant (SAGhE) study, involved patients who had idiopathic growth hormone deficiency and idiopathic or gestational short stature. The FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.

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. 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.

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Source: FDA
Publication Date: 2010-12-24
Last Updated: 2010-12-24

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