This article is more than 5 years old. Information may no longer be current.
FDA: Evidence inconclusive regarding recombinant human GH use, mortality risk
Click Here to Manage Email Alerts
The FDA is updating the public about its ongoing safety review of recombinant human growth hormone and possible risk for death. The agency has determined that, at this time, evidence regarding recombinant human growth hormone and increased mortality risk is inconclusive.
In December 2010, the FDA issued a Drug Safety Communication to inform the public that it was reviewing results of a study conducted in France — the Santé Adulte GH Enfant (SAGhE) study — and other available information on the potential risk between recombinant human growth hormone (rhGH), also known as somatropin, and death.
In an analysis of the SAGhE study, the FDA identified a number of study design weaknesses that limit the study’s interpretation. The agency also reviewed medical literature and reports from the FDA Adverse Event Reporting System. These additional data sources did not provide evidence suggestive of a link between rhGH and an increased risk for death.
Health care professionals and patients should continue to prescribe and use rhGH according to labeled recommendations, the FDA advised.
The agency is continuing to review this safety issue and expects to receive additional data from the SAGhE study in Spring 2012. The FDA will update the public when new information is available.
The recombinant form of human GH is a protein manufactured to be nearly identical to the main form of the naturally occurring human GH. It has approved indications in both adult and pediatric populations. In the US, rhGH is used in the pediatric population to treat short stature due to GH deficiency, including idiopathic GH 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. In the US, somatropin was approved by the FDA in 1995. Medicines on the market currently include Genotropin (Pfizer), Humatrope (Eli Lilly), Norditropin (Novo Nordisk), Nutropin (Genentech), Nutropin AQ (Genentech), Omnitrope (Novartis), Tev-Tropin (Teva Pharmaceuticals), and Saizen and Serostim (EMD Serono).
 |
Follow EndocrineToday.com on Twitter. |