Suspension due to serious risks of kidney injury and death in certain patient populations

The CMDh has endorsed the recommendation to suspend the marketing authorisations of hydroxyethyl-starch (HES) solutions for infusion across the European Union. These products are used as plasma volume replacement following acute (sudden) blood loss, where treatment with alternative products known as ‘crystalloids’ alone is not considered to be sufficient.

The suspension is due to the fact that these medicines have continued to be used in critically ill patients and patients with sepsis despite restrictions on use in these patient populations introduced in 2013 to reduce the risk of kidney injury and death.

The review of HES solutions for infusion has been carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) which reviewed results of drug utilisation studies, together with the currently available data on benefits and risks from clinical trials and observational studies and feedback received from stakeholders and experts. Based on this review, the PRAC concluded that the restrictions introduced in 2013 have not been sufficiently effective.

The PRAC also explored the possibility of introducing additional measures to protect patients at risk but concluded that such measures would be ineffective or insufficient.

The CMDh has now agreed with the PRAC recommendation that, in view of the serious risks that certain patients are exposed to, HES solutions for infusion should be suspended. Alternative treatment options are available.

As the CMDh position was adopted by majority vote, the CMDh position will now be sent to the European Commission, which will take an EU-wide legally binding decision.

Posted on the EMA website on 26 January 2018