FDA Warns of Possible Increased Risk for Death With Somatropin

Megan Brooks

Disclosures

December 23, 2010

December 23, 2010 — The US Food and Drug Administration (FDA) is looking into results from a French study that found that persons with idiopathic growth hormone deficiency and idiopathic or gestational short stature who were treated with long-term recombinant human growth hormone during childhood were at a small increased risk for death compared with individuals in the general French population.

The FDA made the announcement Thursday via its MedWatch Safety Information and Adverse Event Reporting Program. The agency did not define "small" or state anything more specific on the risks seen in the Santé Adulte GH Enfant (SAGhE) study.

"FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review," the posting states.

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

Recombinant human growth hormone, also known as somatropin (rDNA origin) injection, is marketed under the following brand names in the United States: Genotropin (Pfizer), Humatrope (Lilly), Norditropin (Novo Nordisk), Nutropin and Nutropin AQ (Genentech), Omnitrope (Sandoz), Saizen (EMD Serono), and Tev-Tropin (Teva Pharmaceuticals).

Recombinant human growth hormone stimulates tissue growth, linear growth, and protein, carbohydrate, lipid, and mineral metabolism. It is approved for various indications in adults and children.

In the United States, recombinant human growth hormone is used in children to treat short stature resulting from growth hormone deficiency (including idiopathic growth hormone deficiency, Turner syndrome, Noonan syndrome, Prader-Willi syndrome, short stature homeobox-containing gene deficiency, chronic renal insufficiency, idiopathic short stature, and children small for gestational age).

The French SAGhE Study

The French SAGhE study, part of the larger SAGhE Study in Europe, was started in 2007 in collaboration with Agence Française de Sécurité Sanitaire et des Produits de Santé, French Drug Agency, the Ministry of Health, and the National Cancer Institute of France. The aims of the study are to evaluate the long-term health of patients who have been treated with biosynthetic growth hormone in childhood, including long-term mortality and long-term cancer incidence. The SAGhE study in France has included 10,489 patients.

In SAGhE, there was a 30% 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 increase in mortality risk could be related to bone cancers and to cardiovascular diseases and cerebrovascular events — primarily subarachnoid and intracerebral hemorrhage.

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 approved doses in the United States for pediatric growth hormone deficiency are less than 50 μg/kg/day, except during puberty, when a higher dose regimen is approved for a limited duration. The currently approved maximum dose for short stature indications other than growth hormone deficiency is 69 μg/kg/day, or 0.48 mg/kg/week.

The full FDA safety communication can be found on the FDA's Web site.

More information on the French SAGhE study and the SAGhE Study in Europe can be found on the study's Web site.

Adverse events related to recombinant human growth hormone products should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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