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European Medicines Agency to review safety of somatropin-containing medicines
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The European Medicines Agency announced that it is starting a review to examine the safety of somatropin-containing medications, based on recent data that suggested an increased risk for mortality with this growth hormone therapy.
According to the agency, the review will focus on “all available data on somatropin to reassess the benefit-risk balance of these medications.”
Results of a long-term epidemiological study in patients treated with somatropin-containing medicines during childhood suggest an increased risk for mortality with therapy compared with the general population. The risk appears to be further increased with high doses. The study was started in October 2007 in France and included 7,000 patients who were treated with somatropin for GH deficiency or short stature of unknown cause between 1985 and 1996.
“Based on this observational study alone, the risk cannot be associated with certainty to the GH treatment. The results need to be confirmed and complemented with further analyses,” according to a statement in the European Medicines Agency (EMA) press release.
Somatropin is used to promote growth during childhood and adolescence, and it may also affect the way the body handles proteins, fat and carbohydrates. The therapy is used to treat a number of conditions associated with a lack of GH and short stature, including Turner’s syndrome and chronic renal insufficiency.
There are currently three authorized somatropin-containing medicines in the European Union (Nutropin Aq, Roche; Omnitrope, Novartis; Valtropin, BioPartners GmbH).
In the United States, somatropin was approved by the FDA in 1995 for children and adults with GH deficiency. Other medicines on the market include Genotropin (Pfizer), Humatrope (Eli Lilly), Norditropin (Novo Nordisk), and Saizen and Serostim (EMD Serono).
The EMA is expected to provide further information on its review shortly. In the meantime, prescribers are urged to strictly follow the approved indications and doses.
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