HES solutions must no longer be used to treat patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients, because of an increased risk of kidney injury and mortality.
The decision was taken by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) after completing its review of hydroxyethyl-starch solutions (HES) solutions following an assessment of new information and commitments from companies for additional studies and risk minimisation activities.
But HES solutions may continue to be used in patients to treat hypovolaemia (low blood volume) caused by acute blood loss, provided that appropriate measures are taken to reduce potential risks and that additional studies are carried out.
The review of HES solutions was initially triggered by the German medicines agency, the Federal Institute for Drugs and Medical Devices (BfArM), following studies showing an increased risk of mortality in patients with sepsis and an increased risk of kidney injury requiring dialysis in critically ill patients following treatment with HES solutions.
The PRAC had initially concluded on 13 June 2013 that HES solutions should be suspended in all patient populations. Since then, the PRAC has analysed and considered new evidence that was not available at the time of the initial recommendation, including new studies. The Committee has also looked at new proposals for additional risk minimisation measures, including restrictions on use and a commitment from the companies to conduct additional studies.
The PRAC, on the basis of all data available to date, considered whether a group of patients could be identified for whom HES treatment remains beneficial. The Committee concluded that there was clear evidence for an increased risk of kidney injury and mortality in critically ill and septic patients, and that therefore HES should no longer be used in these patients.
However, the PRAC agreed that HES could continue to be used in patients with hypovolaemia caused by acute blood loss where treatment with alternative infusions solutions known as ‘crystalloids’ alone are not considered to be sufficient.
Moreover, the PRAC acknowledged the need for measures to minimise potential risks in these patients and recommended that HES solutions should not be used for more than 24 hours and that patients’ kidney function should be monitored for at least 90 days.
In addition, the PRAC requested that further studies be carried out on the use of these medicines in elective surgery and trauma patients.
The PRAC recommendation will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), for consideration at its meeting on 21-23 October 2013.