Heparin scare spreads in Europe

The countries join the US, Germany, Switzerland and Japan in pulling various forms of the drug from the market after links to Chinese-made active pharmaceutical ingredients (API) were made. The health scare first sparked off when the US Food and Drug Administration (FDA) received hundreds of reports of serious injuries and/or deaths in patients who had been administered heparin​ made by Baxter​. The company had sourced its refined API from Scientific Protein Laboratories (SPL), who had sourced the raw material from China​. The lots in question were recalled in February. It has since been revealed by an FDA investigation that the drug lots in question were contaminated with a substance called oversulfated chondroitin sulphate, which is made from animal cartilage and is a cheaper alternative to raw heparin, which is normally derived from pig's intestines. It is not approved for use in medicine. The recall in the latest three countries is a precautionary measure only at this point, with a European Medicines Agency (EMEA) spokesperson confirming that there have been no reports of adverse reactions from heparin being taken by patients in any of the three countries. However, some of the recalled lots have been found to be contaminated with what is presumed to be the same substance - oversulfated chondroitin sulfate - that was found in batches of Baxter's product. The contaminant's identity is yet to be confirmed said the EMEA. In Italy, it is a company called Opocrin that has pulled its drug from the market after it said it sourced some ingredients from China's Shenzhen Hepalink Pharmaceutical Co that turned out to be contaminated. Incidentally, this same Chinese firm also supplies raw heparin to APP Pharmaceuticals in the US, who is the country's only supplier of large-dose heparin still selling the drug, after Baxter temporarily withdrew from the market last month. However, so far, AAP's heparin has been tested by the FDA and found to be contaminant free, although the firm is conducting ongoing tests to remain vigilant. Additionally, France has been recalling finished heparin product manufactured by Rotexmedica, after heparin made by the same company was linked to over 80 adverse reactions in patients in Germany. Although the product in question was manufactured locally in Germany, the drug's API has also been associated with two Chinese suppliers and batches of the drug were recalled last month. Meanwhile, a screening test designed specifically by the FDA to indentify oversulfated chondroitin sulfate, which had not been detected using standard testing methods, has now been passed on to all countries in the European Union, all of which are now believed to be testing their heparin for the presence of any contamination, said the EMEA.