Case study: contamination of heparin with oversulfated chondroitin sulfate
Review published in Handbook of experimental pharmacology (2012)
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.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Резюме
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.
Почему это важно для гирудотерапии
This article reviews the 2007-2008 heparin contamination crisis, describing how an FDA-led consortium and Baxter Healthcare isolated and identified oversulfated chondroitin sulfate as the root cause of allergic-type adverse events including acute hypotension, nausea, and shortness of breath. The contaminant was shown to produce acute hypotension in animal models, supporting it as the causative agent. The work underscores the importance of safety and purity in biological therapeutics. However, the abstract makes no mention of leeches, hirudotherapy, hirudin, or leech secretions, so there is no direct relevance to the ASH domain. Any connection to hirudotherapy would be purely conceptual, relating to general safety concerns for biological or animal-derived therapies.
Цитирование
Case study: contamination of heparin with oversulfated chondroitin sulfate
Chess EK et al. · Handbook of experimental pharmacology, 2012
Связанный клинический контекст
Узнайте, как это исследование связано с клинической практикой
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