Contaminant in the recalled unfractionated heparin preparations: Where is the problem?

Clinical and Applied Thrombosis/Hemostasis

Volumn 14, Issue 3, 2008, Pages 261-266

  Hoppensteadt, Debra A ^a   Wahi, Rakesh ^a   Adiguzel, Cafer ^a   Iqbal, Omer ^a   Ramacciotti, Eduardo ^a   Bick, Rodger L ^a   Messmore, Harry L ^a   Bansal, Vinod ^a   Fareed, Jawed ^a  

^a LOYOLA UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALLERGEN; BRADYKININ; CHITOSAN; CHONDROITIN SULFATE; DERMATAN SULFATE; GLUCOSAMINE SULFATE; HEPARAN SULFATE; HEPARIN; HEPARIN DERIVATIVE; HEPARINOID; KALLIKREIN; LOW MOLECULAR WEIGHT HEPARIN;

ABDOMINAL PAIN; ALLERGY; APHERESIS; BLEEDING; BURN; CHEMICAL MODIFICATION; CONSCIOUSNESS DISORDER; DEPOLYMERIZATION; DIARRHEA; DIZZINESS; DRUG CONTAMINATION; DRUG FATALITY; DRUG INDICATION; DRUG ISOLATION; DRUG MANUFACTURE; DRUG MARKETING; DYSPEPSIA; DYSPNEA; EDITORIAL; FLUSHING; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HEADACHE; HEART ARRHYTHMIA; HEART PALPITATION; HEMODIALYSIS; HEPARIN INDUCED THROMBOCYTOPENIA; HUMAN; HYPERTHYROIDISM; HYPESTHESIA; HYPOTENSION; LACRIMATION; MALAISE; NAUSEA; NUCLEAR MAGNETIC RESONANCE; PALLOR; PARESTHESIA; PHARYNX DISEASE; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; RESTLESSNESS; SHELLFISH; SIDE EFFECT; STANDARDIZATION; STOMACH DISCOMFORT; TACHYCARDIA; THIRST; THORAX PAIN; TRISMUS; VOMITING; WORLD HEALTH ORGANIZATION;

ANIMALS; ANTICOAGULANTS; DRUG AND NARCOTIC CONTROL; DRUG CONTAMINATION; HEPARIN; HUMANS; QUALITY CONTROL; SUS SCROFA; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 45749095434     PISSN: 10760296     EISSN: None     Source Type: Journal    
DOI: 10.1177/1076029608317932     Document Type: Editorial

References (9)

1. 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
2. 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
3. 2008 Heparin Recall Information. Baxter Investigation Updates (5, 14, 19 March 2008). http://www.baxter.com/products/biopharmaceuticals/heparin.html
4. Baxter provides update on investigation. Baxter Investigation Update (14 March 2008). http://www.baxter.com/products/biopharmaceuticals/downloads/ heparin_03-14-08/pdf
5. Communication. Information on heparin sodium injection. US Food and Drug Administration. http://www.fda.gov/cder/drug/infopage/heparin/default.htm
6. 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.
7. Guerrini M., Beccati D., Shriver Z., et al. Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events. Nature Biotechnology. 10 :p 1-7 ; 208, 2008.
8. 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.
9. 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.