[2][3] HES is a general term and can be sub-classified according to average molecular weight, molar substitution, concentration, C2/C6 ratio and Maximum Daily Dose.

An intravenous solution of hydroxyethyl starch is used to prevent shock following severe blood loss caused by trauma, surgery, or other problem.

HES derivatives have been demonstrated to have increased rates of acute kidney failure and need for renal replacement therapy and to decrease long-term survival when used alone in cases of severe sepsis compared with Ringer lactate solution.

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).

Specifically, the authors showed that resuscitation with hydroxyethyl starch (as opposed to Ringer's acetate) resulted in an increased risk of death or end stage renal failure.

[17] 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.

[18] As a consequence, in November 2012 the European Regulatory Agency (EMA) started an Official Procedure to Assess the Safety of all HES Products.

[19] On June 14, 2013, PRAC, which is the safety committee of EMA, the European regulatory agency, published on their official website the recommendation to suspend the marketing authorisation of all HES products in Europe.

A clinical benefit could not be demonstrated in any patient population, and there was ample evidence of harm, especially kidney failure due to long-term storage of the product in vital organs severely restricting its potential indications.

MHRA recalled the HES products on June 27 as the risks outweigh potential benefits and safer and cheaper alternatives are available.

Due to side effects also in the patients in the operating room the product should only be used, when no other fluid for volume replacement therapy is available.

[24] In April 2018, the European Commission requested that the PRAC and the CMDh further consider any possible unmet medical need that could result from a suspension, as well as the feasibility and likely effectiveness of additional risk minimisation measures.

The CMDh concluded that HES solutions for infusion should remain on the market provided that a combination of additional measures to protect patients is implemented.