Hydroxyethyl-starch solutions should no longer be used in patients with sepsis or burn injuries

31-Oct-2013 - United Kingdom

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 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 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 sepsis1,2 and an increased risk of kidney injury requiring dialysis in critically ill patients1,2,3 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).

https://www.bionity.com/en/news/145621/hydroxyethyl-starch-solutions-should-no-longer-be-used-in-patients-with-sepsis-or-burn-injuries.html