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.
Resumen
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.
Por qué esto importa para la hirudoterapia
Este artículo revisa la crisis de contaminación de heparina de 2007-2008, describiendo cómo un consorcio dirigido por la FDA y Baxter Healthcare aislaron e identificaron el sulfato de condroitina sobresulfatado como la causa principal de eventos adversos de tipo alérgico, incluyendo hipotensión aguda, náuseas y disnea. Se demostró que el contaminante produce hipotensión aguda en modelos animales, lo que respalda su papel como agente causal. El trabajo subraya la importancia de la seguridad y la pureza en los productos terapéuticos biológicos. Sin embargo, el resumen no menciona sanguijuelas, hirudoterapia, hirudina ni secreciones de sanguijuela, por lo que no existe relevancia directa con el dominio de ASH. Cualquier conexión con la hirudoterapia sería puramente conceptual, relacionada con las preocupaciones generales de seguridad para las terapias biológicas o de origen animal.
Citación
Case study: contamination of heparin with oversulfated chondroitin sulfate
Chess EK et al. · Handbook of experimental pharmacology, 2012
Contexto clínico relacionado
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026