The European Medicines Agency said Dec. 10 that it was reviewing the safety of somatropin-containing medicines, following reports linking these to increased mortality in people treated with them as children.
Somatropin is a recombinant human growth hormone used to counter very short stature in growing children. The EMA said it had launched the review in response to preliminary results from an observational study of over 10,000 French patients begun in 2007. The EMA said that AFSSAPS, the French Agency for the Safety of Health Products, brought the issue to its attention.
Approximately 40,000 European children are treated with daily injections of somatropin-containing medicines, according to the official Web site of the Safety and Appropriateness of Growth hormone treatments in Europe, or SAGhE study, which is funded by the European Community and health agencies in eight European countries.
The SAGhE study, which began in France in 2007, last year expanded recruitment to Belgium, Germany, Italy, the Netherlands, Sweden, Switzerland, and the United Kingdom, and intends to evaluate 30,000 patients. The study is looking into overall and cancer-related mortality in relation to treatment with somatropin-containing medicines. It is scheduled to end on May 31, 2012.
The preliminary French results, the EMA said on Dec. 10, "suggest an increased risk of mortality with somatropin therapy compared to the general population. The risk appears to be particularly increased when high doses are used (beyond doses as recommended in the Summary of Product Characteristics)." The agency did not detail or publish the results, however, and cautioned that they need to be confirmed through further analysis.
The three somatropin-containing medicines licensed throughout the European Union are NutropinAq, Omnitrope, and Valtropin. Other somatropin-containing medicines are licensed by individual EU countries.