Recent Safety Concerns
High molecular weight HES has been linked to coagulopathy, pruritus, as well as nephrotoxicity, acute renal failure and mortality. On the other hand, low molecular weight HES seems not to demonstrate such adverse effects. However, some suggest that low molecular weight HES poses significant safety concerns. They posit that studies concluding otherwise are not reliable for a number of reasons including “unsuitable comparators, too short observation periods, low cumulative dose and low-risk patients.” (Hartog & Reinhart, 2009, p 1340). Recent results of 6S trial seem to confirm these concerns (see below).
In June 2012 6S paper was published in the New England Journal of Medicine raising concerns regarding the use of hydroxyethyl starch in sepsis - specifically, resuscitation with hydroxyethyl starch (as opposed to Ringer's acetate) resulted in an increased risk of death or end stage renal failure. This study used Tetraspan (HES 130/0.42) of the pharmaceutical company B.Braun but the original version of the publication contained the product specification HES 130/0.4. The pharmaceutical company, Fresenius Kabi, that makes a similar product but with the specification HES 130/0.4 is threatening to bring legal action against the author, Anders Perner, as they wanted the misleading use of their product specification to be corrected. The academic community has raised concerns regarding this sort of behavior by a corporation although Fresenius Kabi did not doubt the results of the study.
Read more about this topic: Hydroxyethyl Starch
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