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Growth Hormone Safety Being Investigated by FDA

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The move comes on the heels of a French study that found certain children given recombinant human growth hormone products had "a small increased risk of death" compared with the overall population.

Earlier this month, European officials said they would review the drugs following the French findings but that safety was not an immediate concern.

The FDA move affects: Novo Nordisk A/S' Norditropin, Roche's NutropinAQ, Novartis AG generics unit Sandoz's Omnitrope, EMD Serono's Saizen, Teva Pharmaceutical Industries Ltd Tev-Tropin and Pfizer Inc's Genotropin, Eli Lilly & Co's Humatrope.

Known chemically as somatropin, recombinant human growth hormone is an injectable protein that aims to stimulate tissue growth, height and metabolism, according to the FDA.

Recombinant human growth hormone products are used to treat a variety of conditions, including short stature in children and adults, Turner syndrome, and chronic renal insufficiency, the agency said.

FDA said it was reviewing the information on the possible risk from recombinant human growth hormone products and would issue any new recommendations regarding the use of recombinant human growth hormone products once it completed its review.

"At this time, FDA recommends that patients continue their recombinant human growth hormone treatment as prescribed by their healthcare provider."

The French review, known as the Sante Adulte GH Enfant (SAGhE) study, began in 2007 and analyzed about 7,000 children who began taking the hormone drug between 1985 and 1996, according to European officials. It has not yet been published.

The study found a 30 percent increase in death in those patients, FDA said. Ninety-three patients taking the hormone died compared with 70 people in the general population in France.

Last modified on Friday, 02 September 2011 12:54
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