Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm.

Summary:

• In 2013 the use of HES solutions for infusion was restricted because of an increased risk of kidney injury and mortality in certain patient populations.
• Despite extensive measures in place to protect vulnerable patient populations, final results of a drug utilisation study have shown continued high non-adherence to the product information including non-adherence to contraindications.
• No further measures have been identified to further improve adherence and mitigate these risks which exposes patients to potential serious harm, including increased mortality.
• As a consequence, HES solutions for infusion have now been suspended from the EU market. 
• Healthcare professionals should no longer use HES solutions for infusion and consider other appropriate treatment alternatives according to relevant clinical guidelines.
• Recall information, if applicable, including level (pharmacy) and date of recall

Published on: 31 May 2022