Contaminant in the Recalled Unfractionated Heparin Preparations: Where is the Problem?

Contaminant detected in heparin material of specified origin in the USA and in Germany: serious adverse events reported: recall measures initiated. World Health Organization Alert No. 118(& March 2008). http://www .who,int/medicines/publications/drugalerts/Alert_118_ Heparin.pdf

Notice of Recall from Rotexmedica to Bfarm (German Regulatory Authorities). Rotexmedica/Bfarm Notice (& March 2008). http:www.akdae.de/20/40/Archiv/2008/ 2008-310.pdf

2008 Heparin Recall Information. Baxter Investigation Updates (5, 14, 19 March 2008). http://www.baxter .com/products/biopharmaceuticals/heparin.html

Baxter provides update on investigation. Baxter Investigation Update (14 March 2008). http://www.baxter.com/products/ biopharmaceuticals/downloads/heparin_03-14-08/pdf

Communication. Information on heparin sodium injection. US Food and Drug Administration. http://www.fda.gov/ cder/drug/infopage/heparin/default.htm

Maruyama T. , Toida T. , Imanari T. , et al. Conformational changes and anticoagulant activity of chondroitin sulfate following its O-sulfonation. Carbohydr. Res. 306, 35-43, 1998.

Guerrini M. , Beccati D. , Shriver Z. , et al. Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events. Nature Biotechnology. 10:p1-7; 208, 2008.

Kishimoto TK , Viswanathan K. , Ganguly T. , et al. Contaminated heparin associated with adverse clinical effects and activation of the contact system. N J Med. Published at www.nejm.org, April 23, 2008.

Fareed, J. An update on the issues related to the contaminant in heparin. NATF, http://www.natfonline.org/mar08/ethrombosis.php . Reviewed May 20, 2008.