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UPDATE 1-EU agency to review safety of somatropin drugs

Published 12/10/2010, 08:10 AM
Updated 12/10/2010, 08:12 AM

* Review started after study suggested increased death risk

* Pfizer, Eli Lilly, Novartis unit have somatropin drugs

(Adds details of some manufacturers, more detail from statement)

LONDON, Dec 10 (Reuters) - European drugs regulators said on Friday they are starting a review of the safety of somatropin-containing medicines after a study suggested the growth hormone treatments increased the risk of death.

"The review will look into all available data on somatropin to reassess the benefit-risk balance of these medicines," the European Medicines Agency said in a statement.

Manufacturers of somatropin-containing medicines include Pfizer, whose product is called Genotropin, and Novartis' generics unit Sandoz, whose Omnitrope medicine was the first biosimilar drug to be approved by European regulators in 2006. Eli Lilly & Co has a version called Humatrope and generic drugmaker BioPartners has one called Valtropin.

Somatropin is a human growth hormone, made using recombinant DNA technology. It promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.

The drug is used to treat a number of conditions linked with a lack of growth hormone and short stature. This includes children who fail to grow due to a lack of growth hormone, and people with Turner syndrome or chronic renal insufficiency.

EMA said the review was started after information was received from the French medicines agency on a long-term epidemiological study in patients treated during childhood with somatropin-containing medicines.

"The study results suggest an increased risk of mortality with somatropin therapy compared to the general population," the regulator said in a statement, adding: "The risk appears to be particularly increased when high doses are used."

EMA said that based on this observational study alone, the risk could not be linked with certainty to the growth hormone treatment, but the results need to be confirmed and complemented in further research.

The regulator said it would give more information on the sompatropin review after the scheduled meeting of its Committee for Medicinal Products for Human Use (CHMP) from Dec. 13 to 16. (Reporting by Kate Kelland; Editing by Hans Peters)

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