Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation

  • European Medicines Agency

The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) endorse the suspension of hydroxyethyl-starch (HES) solutions, due to serious risks of kidney injury and death in certain patient populations.

Following the recent Pharmacovigilance Risk Assessment Committee (PRAC) review, the CMDh has endorsed the suspension of HES solutions use for plasma volume replacement in cases of acute blood loss where treatment with crystalloids alone is not considered to be sufficient.

Consisting of results from drug utilisation studies, clinical trials and observational studies, in addition to feedback from stakeholders and experts, the PRAC review concluded that 2013 restrictions had not been sufficiently effective. As a result, these medications continued to be used in critically ill and sepsis patients. The result of this practice, can lead to a serious risk of kidney injury and death in certain patient populations. With these findings, PRAC recommended suspending the marketing authorisations of HES solutions for infusion across the European Union.

Due to the serious risk certain patients are being exposed to, the CMDh agreed to suspend HES solutions for infusion. Alternative treatment options are available (such as albumin, gelatins and dextrans) and more information can be found in the Intravenous fluids section of the Fluid Management Knowledge Centre.

The suspension reflects the difficulties faced in clinical practice in clearly distinguishing which patients should or should not be administered HES solutions for infusion. What’s more, some patients may become critically ill or septic whilst receiving the treatment. However, while these products are being suspended across the EU, the use of HES solutions in clinical trials where patient selection is tightly controlled will not be affected.

The CMDh position will now be sent to the European Commission, which will make the final EU-wide legally binding decision.

Update: In July 2018 the European Commission took the EU-wide, legally binding decision to continue the marketing of HES under new restrictions. Learn more about these restrictions and how the decision was made with our interactive HES timeline.

Explore the Fluid Management Knowledge Centre to discover more about the role of fluid therapy in cardiac surgery, critically ill patients, liver cirrhosis, and more.

Catch-up on the debate surrounding hydroxyethyl starch use as we take you on an interactive journey through its changing fortunes. Do you think current restrictions will be enough to change clinical practice?

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