The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), has endorsed by majority the recommendations of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that hydroxyethyl-starch solutions (HES) 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 CMDh also agreed with the PRAC recommendation that HES solutions may continue to be used in patients to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss, where treatment with alternative infusions solutions known as ‘crystalloids’ alone are not considered to be sufficient. In order to minimise potential risks in these patients, HES solutions should not be used for more than 24 hours and patients’ kidney function should be monitored after HES administration. In addition to updating the product information, further studies should be carried out on the use of these medicines in elective surgery and trauma patients.

The review of HES solutions was carried out by the PRAC following the publication of 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.

As the CMDh position has been adopted by majority vote, it will now be sent to the European Commission, which will take a final legally binding decision that will be valid throughout the European Union (EU).

Information for patients; Because of the risk of kidney injury and mortality, HES solutions must no longer be used in patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients; HES solutions may continue to be used to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss. However, the doctor should monitor the patient’s kidney function after HES administration; Patients who have any questions or concerns should speak to the treating doctor, pharmacist or nurse.

Information for healthcare professionals:  Because of the risk of kidney injury and mortality, HES solutions must no longer be used in patients with sepsis, burn injuries or critically ill patients;  HES solutions should only be used for the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient; There is a lack of robust long-term safety data in patients undergoing surgical procedures and in patients with trauma. The expected benefit of treatment should be carefully weighed against the uncertainties with regard to long-term safety, and other available treatment options should be considered. Additional studies will be performed with HES solutions in patients with trauma and in elective surgery; HES solutions should be used at the lowest effective dose for the shortest period of time. Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as appropriate haemodynamic goals have been achieved; HES solutions are now contraindicated in patients with renal impairment or renal replacement therapy. The use of HES must be discontinued at the first sign of renal injury. An increased need for renal replacement therapy has been reported up to 90 days after HES administration. Patients’ kidney function should be monitored after HES administration;   HES solutions are contraindicated in severe coagulopathy. HES solutions should be discontinued at the first sign of coagulopathy. Blood coagulation parameters should be monitored carefully in case of repeated administration.

These recommendations are based on a review of all available safety and efficacy data, including recent data, from clinical studies, meta-analyses and post-marketing experience.

Healthcare professionals will be informed in writing of the outcome of the review and the changes to the use of HES solutions.

Infusion solutions containing HES are frequently used for volume replacement and belong to the class known as colloids. There are two main types of medicines used for volume replacement: crystalloids and colloids. Colloids contain large molecules such as starch, whereas crystalloids, such as saline (salt) solutions or Ringer’s acetate, contain smaller molecules.

In the EU, HES-containing solutions for infusion have been approved via national procedures and are available in all Member States under various trade names.