FDA Reviews HGH Safety

Published:December 23rd, 2010

 

FDA is going to take a closer look at recombinant human growth hormone products in order to see if they increase death risk. Following a French study that has revealed that children given the hormone showed a small increased risk of death, FDA issued a statement on Wednesday, December 22, 2010. The investigation will include products such as Genotropin from Pfizer Inc., Humatrope from Eli Lilly & Co, Norditropin from Novo Nordisk. Other products are NutropinAQ produced by Roche, Sandoz’s Omnitrope, Saizen from EMD Serono and Tev-Tropin from Teva Pharmaceutical Industried Ltd.

The recombinant HGH is an injectable protein that is aimed at stimulating tissue growth, height and metabolism and is used to treat various conditions, including short stature in children, Turner syndrome or chronic renal insufficiency. Once FDA completes its review, it will issue new recommendations.

European officials are also going to review such drugs due to the recent findings of the French study. Safety is not the immediate concern and FDA recommended patients to continue their treatment as prescribed by healthcare providers.

The Sante Adulte GH Enfant study analyzed about 7,000 children who took the HGH products between 1985 and 1996. A 30% increase in death of such patients was the cause of these concerns.

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