Use of Hydroxyethyl-Starch Solutions to Be Discontinued in Most Patients

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA; London, UK) has completed its review of HES solutions following an assessment of new information and commitments from companies for additional studies and risk minimization activities. The Committee confirmed that HES solutions must no longer be used to treat patients with sepsis or burn injuries or critically ill patients, because of an unacceptable increased risk of kidney injury and mortality. The review 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.

On the basis of all data available to date, the PRAC considered whether a group of patients could be identified for whom HES treatment remains beneficial. PRAC agreed that HES could continue to be used in patients with hypovolaemia (low blood volume) caused by acute blood loss where treatment with alternative infusions solutions (crystalloids) alone are not considered to be sufficient, and provided that appropriate measures be taken to minimize potential risks. PRAC recommended that HES solutions should not be used for more than 24 hours and that kidney function should be monitored for at least 90 days. In addition, the PRAC requested that further studies be carried out, also for use in elective surgery and trauma patients. The PRAC has also looked at new proposals for additional risk minimization measures.

As HES-containing solutions for infusion are all authorized nationally, the PRAC recommendation will now be forwarded to the European Union’s Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh), which will adopt a final position.

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European Medicines Agency