More Heparin Recalls in Europe and US

March 25, 2008 (London, UK) – The heparin-contamination saga is continuing, with the latest countries to recall products being France, Italy, and Denmark.

The heparin products recalled in France are medicinal products manufactured by Rotexmedica, the same company that supplied the heparin products recalled previously in Germany. These were recalled in Germany because of an association with an increased rate of adverse events. A spokesperson from the European Medicines Agency (EMEA) told heartwire that no additional adverse reactions had been reported in France, but that Rotexmedica was recalling a limited number of batches "because of a suspicion of the presence of a contaminant."

In Italy and Denmark, the recall involves a number of batches of heparin active pharmaceutical ingredient (API) made by the Italian company Opocrin. The EMEA spokesperson said he didn't think these batches of heparin API had made their way into the final heparin medicinal products as yet and were being recalled because the presence of a contaminant had been confirmed. He added: "We presume this is the same contaminant as identified in the US, as it has been detected by the same tests as used in the US, but we have no definite confirmation of the identity of the contaminant found in the Opocrin heparin API as yet."

He added that the heparin medicinal products from Rotexmedica and the heparin API from Opocrin had all been manufactured using products sourced originally from China by four Chinese companies. Rotexmedica's heparin products were sourced from Changzhou Qianhong Biopharmaceutical Co Ltd and Yantai Dongcheng Biopharmaceutical Co Ltd, while Opocrin's heparin API had been sourced from Yantai Dongcheng Biopharmaceutical Co Ltd, Shenzen Hepalink Pharmaceutical Co Ltd, and Shanghai No 1 Biochemical Co Ltd. These appear to be different from the Chinese company to which affected heparin in the US has been traced (Changzhou Scientific Protein Labs).

The EMEA spokesperson explained to heartwire that heparin products were regulated by each individual country in Europe. EMEA, being the centralized medical agency, was just providing an information-sharing role on the issue. He added that as there were many companies supplying heparin in Europe, it was not expected that a heparin shortage would occur.

Another US manufacturer affected

Meanwhile, another US heparin manufacturer has recalled some heparin products because of concern about the contaminant. B Braun Medical is recalling 23 lots of heparin after its supplier, Scientific Protein Laboratories, disclosed that one lot of heparin sodium active pharmaceutical ingredient supplied to B Braun may contain the contaminant implicated in the adverse reactions. To date, B Braun has not received any adverse-event reports related to these products, the company said.

The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

Source: Heartwire

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