The EMA Pharmacovigilance Risk Assessment Committee (PRAC) recommends against hydroxyethyl-starch (HES) solutions for infusion

  • European Medicines Agency

A recent PRAC review has recommended suspension of marketing authorisations for HES solutions for infusion across the EU. Results from drug utilisation studies were reviewed, along with benefit and risk data from clinical trials and observational studies as well as feedback from stakeholders and experts.

Intravenous fluids used for resuscitation of acutely ill patients replace plasma volume and prevent shock following acute blood loss. Intravenous fluids comprise colloid and crystalloid solutions. Colloid solutions increase the relative oncotic pressure of the intravascular space by including molecules that are too large to extravasate, such as starches. Crystalloid solutions are aqueous solutions of salts and other water-soluble molecules, such as saline or Ringer’s solutions. Colloid solutions, including those containing HES, are currently used when treatment with crystalloid solutions alone is not sufficient. Restrictions on the use of HES solutions in critically ill patients and those with sepsis and kidney injury were introduced in 2013 to reduce risk of kidney injury and mortality in these patient populations. These restrictions stated that HES solutions should not be used for more than 24 hours and that patients’ kidney function should be monitored after HES administration.

The PRAC review concluded that the 2013 restrictions have not been sufficiently effective. In view of the serious risks to certain patient populations, the PRAC has recommended suspension of the marketing authorisations for HES solutions and this was considered by the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) 22–25 January, 2018. A position from the CMDh will be adopted and announced in due course.

This press release offers an important update to current fluid management best practice. There are alternative colloids that can be used to replace plasma volume which contain albumin, gelatin or dextran. Visit the Intravenous Fluids section of the Fluid Management Knowledge Centre for more information.

Update: In July 2018 the European Commission took the EU-wide, legally binding decision to continue the marketing of HES under new restrictions. Learn more about these restrictions and how the decision was made with our interactive HES timeline.

Explore the Fluid Management Knowledge Centre to discover more about the role of fluid therapy in cardiac surgery, critically ill patients, liver cirrhosis, and more.

Catch-up on the debate surrounding hydroxyethyl starch use as we take you on an interactive journey through its changing fortunes. Do you think current restrictions will be enough to change clinical practice?

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Publications (27)
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    Following the European Medicines Agency’s (EMA) suspension of the marketing authorisations of hydroxyethyl starch (HES) solutions across the European Union (EMA, 2018), Roberts et al., have written an open letter addressed to the World Health Organization (WHO) Director General seeking support for the suspension of HES solutions and expanding it to a worldwide ban.

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    In 1896 Ernest Starling published his hypothesis for fluid exchange, whereby fluid exchange exists mainly in the capillaries through a process of plasma ultrafiltration across semipermeable membranes (Starling, 1896). But is this 19th century theory something of the past?

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