Brussels, 09/06/2008 (Agence Europe) - The European Medicines Agency (EMEA) says in a press release published on Thursday 5 June that it has reviewed the risks associated with the use of heparin (used to prevent thrombosis) medicinal products, following the contamination of various batches with oversulphated chondroitin sulphate. This substance caused serious side effects in patients who received injections of unfractionated (standard) heparin. It was also found in low molecular weight heparin, enoxaparin, which is found in a medicine produced by Sanofi-Aventis under the name Lovenox. With no side effects having been reported, this medicine can continue to be used as long as allergic reactions are monitored. It must not, however, be administered intravenously. All batches of standard heparin have been withdrawn from the market. The EMEA calls on the European Commission to examine, with its international partners, how to strengthen checks on the heparin supply chain. The agency also recommends that specific tests for oversulphated chondroitin sulphate and other possible contaminants should be included in the heparin monographs in the European Pharmacopoeia.
Oversulphated chondroitin sulphate contamination has affected products from different laboratories. Chondoitrin, which is used in the treatment of arthrosis, is extracted from pigs' cartilage, and heparin comes from the intestine of the same animals. In its natural state, chondroitin has no coagulant effect. Oversulphated chondroitin sulphate, which is a coagulant and which has been mixed with heparin, is obtained by a chemical process, suggesting that there has been some fraud in one or several abattoirs which extract the two substances, cartilage being cheaper than the mucus removed from the pigs' intestines. A criminal investigation has been opened in China where one of the main contaminated heparin suppliers is located. Contaminated heparin has caused the deaths of at least 80 people in the United States and a further 750 incidents of varying severity (anaphylactic shock, fall in blood pressure). There have been no deaths in the EU. (O.J./transl. rt)