Case study: contamination of heparin with oversulfated chondroitin sulfate

Handbook of Experimental Pharmacology
Edward K ChessTodd Wielgos

Abstract

In late 2007 and early 2008, a cluster of adverse events in patients receiving Heparin Sodium Injection occurred in the United States and in some countries in Europe. The adverse events were reported as being "allergic type" reactions, chiefly characterized by acute hypotension, nausea, and shortness of breath. The root cause of the cluster of adverse events was determined to be a contamination of the heparin by oversulfated chondroitin sulfate. The isolation and structure determination of this contaminant was accomplished by an FDA-led consortium of academic and government laboratories and independently by Baxter Healthcare, whose vial products were first identified in the USA as being associated with the adverse events. Oversulfated chondroitin sulfate was shown to produce acute hypotension in animal models, demonstrating that it was most likely the causative agent responsible for certain of the reported adverse events in patients receiving the contaminated heparin products.

Citations

Oct 5, 2017·Pharmaceuticals·Shifaza Mohamed, Deirdre R Coombe
Dec 17, 2015·Pharmacological Reviews·Barbara MulloyClive P Page
Nov 20, 2016·International Forum of Allergy & Rhinology·Abigail PulsipherJeremiah A Alt
Aug 4, 2019·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Vitor H PominBarbara Mulloy
Jun 13, 2020·Frontiers in Medicine·Elaine GrayTimothy R Rudd
Aug 17, 2021·Therapeutic Advances in Drug Safety·Marco SardellaHervé Le Louet

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