Studies show low adherence to restrictions aimed at reducing risks of kidney injury and death

The European Medicines Agency (EMA) has started a new review of medicines containing hydroxyethyl-starch (HES). These products are used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss, where treatment with alternative infusion solutions known as ‘crystalloids’ alone is not considered to be sufficient. HES medicines are given by infusion (drip) into a vein and are used as blood volume expanders to prevent shock following acute bleeding.

The review is triggered by results from two drug utilisation studies indicating that HES-containing medicines were being used outside their authorised uses, including in critically ill patients and those with sepsis and kidney injury despite restrictions introduced in 2013 to reduce the risks of kidney problems and deaths.

The drug utilisation studies had been requested by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in 2013 as a condition to the marketing authorisationsof these products, in order to verify adherence to the new restrictions.

The PRAC will review the results of these studies, and all other available data, and their impact on the benefit-risk balance of HES-containing medicines for infusion and issue a recommendation on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.

Posted on the EMA website on 27 October 2017