The tainted heparin story: an update.
Recently, certain batches of heparin have been associated with an acute, rapid onset of serious side-effects indicative of allergic-type reactions. These reports generated significant concern regarding the possible presence of a dangerous contaminant within heparin and highlighted the need to re-assess the purity criteria of heparin preparations for clinical use. Given the nature of the array of all possible contaminants, traditional screening tests cannot safely differentiate between contaminated and uncontaminated heparin preparations. Mono- and bi-dimensional NMR spectroscopy are powerful techniques that are able to detect and quantify a wide variety of potential sulfated polysaccharide contaminants. As such, these techniques are powerful tools for the analysis and assessment of heparin preparations.
Guerrini
Marco
M
Institute for Chemical and Biochemical Research, NMR centre, Milan 20133, Italy. guerrini@ronzoni.it
Shriver
Zachary
Z
Bisio
Antonella
A
Naggi
Annamaria
A
Casu
Benito
B
Sasisekharan
Ram
R
Torri
Giangiacomo
G
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000818:Animals; D000925:Anticoagulants / Q000009:adverse effects* / Q000032:analysis / Q000737:chemistry / Q000592:standards; D002648:Child; D002809:Chondroitin Sulfates / Q000009:adverse effects / Q000032:analysis* / Q000138:chemical synthesis / Q000737:chemistry / Q000494:pharmacology; D003167:Complement Activation / Q000187:drug effects; D004196:Disease Outbreaks / Q000662:veterinary; D004340:Drug Contamination; D004342:Drug Hypersensitivity / Q000453:epidemiology / Q000209:etiology*; D006493:Heparin / Q000009:adverse effects* / Q000032:analysis / Q000737:chemistry / Q000592:standards; D006801:Humans; D007610:Kallikreins / Q000378:metabolism; D015394:Molecular Structure; D019906:Nuclear Magnetic Resonance, Biomolecular / Q000379:methods*; D019318:Porcine Reproductive and Respiratory Syndrome / Q000453:epidemiology; D013431:Sulfates / Q000032:analysis; D013552:Swine; D014481:United States; D014486:United States Food and Drug Administration
D000925:Anticoagulants; D013431:Sulfates; D006493:Heparin; D002809:Chondroitin Sulfates; D007610:Kallikreins