FDA to review growth hormone safety, follows EU

U.S. health officials are taking a closer look at recombinant human growth hormone products made by Pfizer, Novartis and other drugmakers to see whether they increase the risk of death.

The move comes on the heels of a French study that found certain children given the hormone had “a small increased risk of death” compared with the overall population, the Food and Drug Administration said in a statement on Wednesday.

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

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.

It is 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 and would issue any new recommendations 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,” it said.

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

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.

FDA made the announcement in a statement on its website at http://url.health.am/20/

(Editing by Steve Orlofsky)

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By Susan Heavey

WASHINGTON