EU Gives Update on Hydroxyethyl-Starch Solution Suspensions

The EU provided an update on the European Commission’s decision in May to suspend marketing authorization for hydroxyethyl-starch (HES) solutions for infusion.

If necessary for public health reasons, EU member states may delay the suspension for up to 18 months and keep the solutions on the markets — as long as they take certain steps to minimize the risks, which include kidney injury and mortality. HES solutions for infusion are contraindicated in patients with sepsis or in critically ill patients.

The risk reduction measures include training, controlled access and warnings on the packaging.

The solutions are normally authorized in the EU as an addition to other treatments for plasma replacement following acute or sudden blood loss. The solutions are used when treatment with alternative products are not sufficient.