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FDA Conducting Somatropin Safety Review | 24-7-news.com cialis online

FDA Conducting Somatropin Safety Review

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The Food & Drug Administration (FDA) is investigating somatropin drugs after a study suggested they might be linked to an increased risk of death in certain patients. Somatropin, also called 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.

According to an FDA alert issued last week, 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 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.

According to the FDA, SAGhE saw a 30 percent increased risk for death with recombinant human growth hormone therapy compared with the general French population. There were 93 deaths in the treated group compared with 70 expected deaths. The risk for death appeared to be dose-related and usually occurred in individuals given doses higher than typically prescribed for pediatric growth hormone deficiency. The agency also said that the data suggested an increase in mortality due to bone tumors and cardiovascular diseases including cerebrovascular events (mainly subarachnoid or intracerebral hemorrhage).

At this time, the FDA recommends that patients continue their recombinant human growth hormone treatment as prescribed by their healthcare provider. The FDA is currently reviewing all available information on this potential risk and said it will communicate any new recommendations once it has completed its review.

In the US, somatropin 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. It is sold under various brand names, including Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropi.

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