Analysis

Concerns over use of hydroxyethyl starch solutions

BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g5981 (Published 10 November 2014) Cite this as: BMJ 2014;349:g5981
  1. Christiane S Hartog, lecturer1,
  2. Charles Natanson, senior investigator2,
  3. Junfeng Sun, staff statistician2,
  4. Harvey G Klein, department chief3,
  5. Konrad Reinhart, department head1
  1. 1Department of Anaesthesiology and Intensive Care Medicine, Centre for Sepsis Care and Control, Jena University Hospital, D-07747 Jena, Germany
  2. 2Critical Care Medicine Department, National Institutes of Health, Bethesda, MD 20892, USA
  3. 3Department of Transfusion Medicine, National Institutes of Health, Bethesda
  1. Correspondence to K Reinhart konrad.reinhart{at}med.uni-jena.de
  • Accepted 4 September 2014

Large trials have shown that hydroxyethyl starch increases the risk of death, kidney injury, and bleeding. However, an EMA review last year permitted continued use in some patients, overturning an earlier decision to withdraw the product completely. Christiane Hartog and colleagues discuss the evidence and call on doctors to avoid using starch formulations

Concerns about serious side effects of hydroxyethyl starch (HES) began to emerge in the 1970s, soon after it was first licensed. The concerns grew after three multicentre randomised trials found that administration of HES in patients who had sepsis or were critically ill was associated with a higher risk of kidney injury and bleeding,1 2 3 and more deaths in patients who had sepsis,1 3 when compared with crystalloids. The trials prompted the German Federal Institute for Drugs and Medical Devices to ask the European Medicines Agency (EMA) to review the use of HES in 2012. The EMA committee (of which KR was a member) recommended suspending all use of HES. However, after manufacturers requested that the decision was reviewed, the UK advised its immediate suspension triggering a second EMA review that decided to permit ongoing HES use under limited circumstances. More than two hundred million units of HES have been administered worldwide during the past 10 years (box). 4 We explain here why we believe that the decision to allow its continued use was not in the best interest of patients.

Use of HES

  • HES is a synthetic carbohydrate polymer marketed as a volume expander in different molecular weights and degrees of substitution

  • More than 20 different HES solutions from several manufacturers are available in the European Union and more than 30 preparations worldwide

  • HES has been used in a variety of clinical settings, including during surgery and to treat hypovolaemia after trauma, burns, and in sepsis, …

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