Press Release: European Medicines Agency recommends action plan to deal with possible presence of endotoxins in Baxter peritoneal dialysis solutions

The European Medicines Agency (EMA) was informed by Baxter, in December 2010, of the potential presence of endotoxins in their peritoneal dialysis solutions Dianeal, Extraneal and Nutrineal. These are sterile solutions used in patients who have to undergo peritoneal dialysis because of kidney failure.

• Primary Source

European Medicines Agency: Press Release: EMA/52545/2011 (21.1.11): Review of the manufacture of Baxter’s peritoneal dialysis solutions initiated over potential presence of endotoxins in some batches http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/01/news_detail_001186.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1

European Medicines Agency: Press Release: EMA/CHMP/771913/2011 (23.9.11): European Medicines Agency finalises review of Baxter’s dialysis solutions http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/09/news_detail_001348.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1

European Medicines Agency: Press Release: EMA/CHMP/825184/2010 (17.12.10) http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/12/WC500099968.pdf

European Medicines Agency: Questions and answers on the presence of endotoxins in Baxter peritoneal dialysis solutions http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2010/12/WC500099974.pdf

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