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.

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12月10日，欧洲药品管理局(EMA)表示其正在审查含生长激素药物的安全性，因为SAGhE研究的初步结果显示这些药物与儿童死亡率增加相关。

 

这项观察性研究于2007年在法国启动，已招募10,000多例法国患者，去年招募范围扩大到比利时、德国、意大利、荷兰、瑞典、瑞士和英国，打算招募约30,000例患者，预计于2012年5月31日结束。本研究目前正在对与含生长激素药物治疗相关的总死亡率和癌症相关死亡率进行分析。

基于法国患者的初步研究结果表明，与一般人群相比，接受生长激素治疗的患者的死亡风险较高，尤其是在大剂量（超过产品特性概要中推荐的剂量）治疗情况下。EMA未对这些结果进行详细说明，亦未予以公布，并谨慎表示这些结果需通过进一步分析加以证实。

目前获准在整个欧盟上市的3种含生长激素药物为NutropinAq、Omnitrope和Valtropin。

本研究获得欧洲共同体和8个欧洲国家的健康机构的资助。

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