Oversulfated chondroitin sulfate and OSCS-contaminated heparin cause dose- and route-dependent hemodynamic effects in the rat

Toxicological Sciences

Volumn 121, Issue 2, 2011, Pages 417-427

  Corbier, Alain ^a   Le Berre, Nathalie ^a   Rampe, David ^a   Meng, Harry ^a   Lorenz, Martin ^b   Vicat, Pascale ^a   Potdevin, Sophie ^a   Doubovetzky, Michel ^a  

^a SANOFI   (France)

^b SANOFI AVENTIS DEUTSCHLAND GMBH   (Germany)

Author keywords

Cardiovascular; Heparin; OSCS; Rat

Indexed keywords

CETIRIZINE; CHONDROITIN SULFATE; HEPARIN; ICATIBANT; KALLIKREIN; OVERSULFATED CHONDROITIN SULFATE; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; DRUG ANTAGONISM; DRUG MECHANISM; DRUG SULFATION; FEMALE; HEART HEMODYNAMICS; HEMODYNAMIC MONITORING; HUMAN; HYPOTENSION; MALE; NONHUMAN; PARTIAL THROMBOPLASTIN TIME; RAT;

CANIS FAMILIARIS; RATTUS; SUIDAE;

EID: 79957814445     PISSN: 10966080     EISSN: 10960929     Source Type: Journal    
DOI: 10.1093/toxsci/kfr072     Document Type: Article

References (24)

1. Adam, A., Montpas, N., Keire, D., Désormeaux, A., Brown, N. J., Marceau, F., and Westenberger, B. (2010). Bradykinin forming capacity of oversulfated chondroitin sulfate contaminated heparin in vitro. Biomaterials 31, 5741-5748.
2. Avorn, J. (2008). Coagulation and adulteration-building on science and policy lessons from 1905. N. Engl. J. Med. 358, 2429-2431.
3. Blossom, D. B., Kallen, A. J., Patel, P. R., Elward, A., Robinson, L., Gao, G., Langer, R., Perkins, K. M., Jaeger, J. L., Kurkijan, K. M., et al. (2008). Outbreak of adverse reactions associated with contaminated heparin. N. Engl. J. Med. 359, 2674-2684.
4. Collignon, F., Frydman, A., and Gaillot, J. (1990). Design and evaluation of analytical methods dedicated to the pharmacokinetic studies of enoxaparin in man: clotting methods and amidolytic methods (anti-Xa activity and anti-Iia or antithrombin activity). Rhone-Poulenc Study Report, ST/IBP/Biodyn. 1498.
5. Fareed, J., Walenga, J. M., Jeske, W. P., Hoppensteadt, D., Prechel, M., Iqbal, O., Adiguzel, C., Clark, M., Litinas, E., Cunanan, J., et al. (2008). Biological profile of the hyper/oversulfated chondroitin sulfate contaminant isolated from recalled heparin. Semin. Thromb. Hemost. 34(Suppl. 1), 119-127.
6. FDA Press Release. (2008a). Baxter recall-firm press release: Baxter issues urgent nationwide voluntary recall of heparin 1,000 units/ml 10 and 30 ml multidose vials. Available at: http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112352.htm. Accessed August 24, 2009.
7. FDA Press Release. (2008b). Baxter recall-firm press release: Baxter to proceed with recall of remaining heparin sodium vial products. Available at: http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112384.htm. Accessed August 24, 2009.
8. FDA Press Release. (2008c). FDA news release: Baxter's multiple-dose vial heparin linked to severe allergic reactions. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116858.htm. Accessed March 1, 2011.
9. 194 Mol. Pharmacol. 61, 391-399.
10. Guerrini, M., Beccati, D., Shriver, Z., Naggi, A., Viswanathan, K., Bisio, A., Capila, I., Lansing, J. C., Guglieri, S., Fraser, B., et al. (2008). Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events. Nat. Biotechnol. 26, 669-675.
11. Hill, S. J., Ganellin, C. R., Timmerman, H., Schwartz, J. C., Shankley, N. P., Young, J. M., Schunack, W., Levi, R., and Haas, H. L. (1997). International Union of Pharmacology. XIII. Classification of histamine receptors. Pharmacol. Rev. 49, 253-278.
12. Hojima, Y., Cochrane, C. G., Wiggins, R. C., Austen, K. F., and Stevens, R. L. (1984). In vitro activation of the contact (Hageman factor) system of plasma y heparin and chondroitin sulfate E. Blood 63, 1453-1459.
13. Jacques, L. B. (1976). "Low-dose heparin"-significance of subcutaneous injection. Thromb. Res. 9, 205-208.
14. Kishimoto, T. K., Viswanathan, K., Ganguly, T., Elankumaran, S., Smith, S., Pelzer, K., Lansing, J., Sriranganathan, N., Zhao, G., Galcheva-Gargova, Z., et al. (2008). Contaminated heparin associated with adverse clinical events and activation of the contact system. N. Engl. J. Med. 358, 2457- 2467.
15. Leeb-Lundberg, L. M., Marceau, F., Müller-Esterl, W., Pettibone, D. J., and Zuraw, B. L. (2005). International union of pharmacology. XLV. Classification of the kinin receptor family: from molecular mechanisms to pathophysiological consequences. Pharmacol. Rev. 57, 27-77.
16. Li, B., Suwan, J., Martin, J. G., Zhang, F., Zhang, Z., Hoppensteadt, D., Clark, M., Fareed, J., and Linhardt, R. J. (2009). Oversulfated chondroitin sulfate interaction with heparin-binding proteins: new insights into adverse reactions from contaminated heparins. Biochem. Pharmacol. 78, 292-300.
17. Moreau, M. E., Garbacki, N., Molinaro, G., Brown, N. J., Marceau, F., and Adam, A. (2005). The kallikrein-kinin system: current and future pharmacological targets. J. Pharmacol. Sci. 99, 6-38.
18. Qian, Y., Pan, J., Zhou, X., Hourcade, D. E., Liszewski, M. K., Atkinson, J. P., Lu, H., and Zhang, L. (2010). Oversulfated heparin by-products induce thrombin generation in human plasmas through contact system activation. Clin. Appl. Thromb. Hemost. 16, 244-250.
19. Ramacciotti, E., Wahi, R., and Messmore, H. L. (2008). Contaminated heparin preparations, severe adverse events and the contact system. Clin. Appl. hromb. Hemost. 14, 489-491.
20. Samuel, M., Pixley, R. A., Villanueva, M. A., Colman, R. W., and Villanueva, G. B. (1992). Human factor XII (Hageman factor) autoactivation by dextran ulfate. J. Biol. Chem. 267, 19691-19697.
21. Schwartz, L. B. (2008). Heparin comes clean. N. Engl. J. Med. 358, 2505-2509.
22. 2 kinin receptors. J. Appl. Physiol. 77, 2675-2680.
23. Warkentin, T. E., and Greinacher, A. (2009). Heparin-induced anaphylactic and anaphylactoid reactions: two distinct but overlapping syndromes. Expert pin. Drug Saf. 8, 129-144.
24. World Health Organization (WHO). (2008). 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. Available at: http://www.who.int/medicines/publications/drugalerts/Alert_118_Heparin.pdf. Accessed April 13, 2011.