From crisis to opportunity: A perspective on the heparin crisis

Thrombosis and Haemostasis

Volumn 102, Issue 5, 2009, Pages 854-858

  Sasisekharan, Ram ^a   Shriver, Zachary ^b  

^a HARVARD MIT DIVISION OF HEALTH SCIENCES AND TECHNOLOGY   (United States)

^b Massachusetts Institute of Technology Cambridge   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HEPARIN;

CONFERENCE PAPER; DRUG CONTAMINATION; DRUG HYPERSENSITIVITY; DRUG IMPURITY; DRUG PURITY; DRUG STRUCTURE; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; ANIMALS; ANTICOAGULANTS; ASIA; CENTERS FOR DISEASE CONTROL AND PREVENTION (U.S.); CHEMISTRY TECHNIQUES, ANALYTICAL; CHILD; CHONDROITIN SULFATES; COMPLEMENT ACTIVATION; DISEASE OUTBREAKS; DRUG CONTAMINATION; DRUG HYPERSENSITIVITY; HEPARIN; HUMANS; KALLIKREINS; MOLECULAR STRUCTURE; PORCINE REPRODUCTIVE AND RESPIRATORY SYNDROME; SWINE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 70449572936     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1160/TH09-02-0083     Document Type: Conference Paper

References (20)

1. Wardrop D, Keeling D. The story of the discovery of heparin and warfarin. Br J Haematol 2008; 141: 757-763.
2. Baxter provides update on investigation. Baxter Investigation Update (14 March 2008). http://www. baxter.com/products/biopharmaceuticals/downloads/ heparin-03-14-08.pdf
3. Communication. Information on heparin sodium injection. US Food and Drug Administration. http://www.fda.gov/cder/drug/infopage/heparin/de fault.htm
4. Guerrini M, Becatti D, Shriver Z, et al. Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events. Nat Biotechnol 2008; 26: 669-675. (Pubitemid 351824692)
5. Hojima Y, Cochrane CG, Wiggins RC, et al. In vitro activation of the contact (Hageman factor) system of plasma by heparin and chondroitin sulfate E. Blood 1984; 63: 1453-1459.
6. Kishimoto TK, Viswanathan K, Ganguly T, al. Contaminated heparin associated with adverse clinical events and activation of the contact system. N Engl J Med 2008; 358: 2457-2467. (Pubitemid 351793019)
7. Schwartz LB. Heparin Comes Clean. N Engl J Med 2008; 358: 2505-2509.
8. Blossom DB, Kallen Aj, Patel PR, et al. Outbreak of adverse reactions associated with contaminated heparin. N Engl J Med 2008; 359: 2674-2684.
9. Greinacher A, Warkentin TE. Contaminated heparin. N Engl J Med 2008; 359: 1291-1292.
10. Wang L, Buchanan S, Meyerhoff ME. Detection of high-charge density polyanion contaminants in biomedical heparin preparations using potentiometric polyanion sensors. Anal Chem 2008; epub.
11. Spencer JA, Kauffman JF, Reepmeyer JC, et al. Screening of heparin API by near infrared reflectance and Raman spectroscopy. J Pharm Sci 2008; epub.
12. Trehy ML, Reepmeyer JC, Kolinski RE, et al. Analysis of heparin sodium by SAX/HPLC for contaminants and impurities. J Pharm Biomed Anal 2008; epub.
13. Tami C, Puig M, Reepmeyer JC, et al. Inhibition of Taq polymerase as a method for screening heparin for oversulfated contaminants. Biomaterials 2008; 29: 4808-4814.
14. Alban S, Lühn S. Prothrombin time for detection of contaminated heparins. N Engl J Med 2008; 359: 2732-2734.
15. Zhang Z, Weïwer M, Li B, et al. Oversulfated chondroitin sulfate: impact of a heparin impurity, associated with adverse clinical events, on low-molecular-weight heparin preparation. J Med Chem 2008; 51: 5498-5501.
16. Laurencin CT and Nair L. The FDA and safety - Beyond the heparin crisis. Nat Biotechnol 2008; 26: 621-623. (Pubitemid 351809581)
17. Avorn J. Coagulation and adulteration - Building on science and policy lessons from 1905. N Engl J Med 2008; 358: 2429-2431.
18. Leiden JM. Canaries and coalmines, and the drug supply. Nat Biotechnol 2008; 26: 624-626.
19. Guerrini M, Raman R, Venkataraman G, et al. A novel computational approach to integrate NMR spectroscopy and capillary electrophoresis for structure assignment of heparin and heparan sulfate oligosaccharides. Glycobiology 2002; 12: 713-719. (Pubitemid 36041475)
20. Conrad HE. Heparin Binding Proteins. (1998) Academic Press, San Diego, CA, USA.