PRAC confirms that hydroxyethil-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients
11.10.2013
The European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has completed the review of hydroxyethil-starch-containing (HES) solutions following an assessment of new information and commitments for additional studies and risk minimisation activities. The PRAC confirmed 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. HES solutions may, however, continue to be used in patients to treat hypovolaemia (low blood volume) cause 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 on 29 November 2012, 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 about what HALMED reported on its web pages (in Croatian).
Since than, the PRAC has analysed and considered new evidence that was not available at the time of the initial recommendation, including new studies. The PRAC has also looked at new proposals for additional risk minimisation measures, including restrictions on use and a commitment 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 PRAC 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. 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. 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 recommendations will now be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedure - Human (CMDh), for consideration at its meeting on 21-23 October 2013.
Here you may find the EMA’s press release
Information about the medicines
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 sodium chloride solution or Ringer’s solution, 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.
