Press Release: European Medicines Agency to review the safety of somatropin-containing medicines

Author (Corporate)
Series Title
Series Details EMA/804468/2010 (10.12.10)
Publication Date 10/12/2010
Content Type

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

The European Medicines Agency (EMA), in December 2010, started a review of the safety of somatropin-containing medicines authorised centrally or by national procedures in the European Union. This review was initiated further to information 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.

Source Link Link to Main Source http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/12/news_detail_001160.jsp&mid=WC0b01ac058004d5c1&murl=menus/news_and_events/news_and_events.jsp
Related Links
EMA: Press Release: EMA/804468/2010 (10.12.10) http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/12/WC500099699.pdf
EMA: Press Release; EMA/CHMP/820649/2010 (16.12.10): Update on somatropin-containing medicines http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/12/WC500099936.pdf

Subject Categories
Countries / Regions