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PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market

Review finds measures to protect patients have not been sufficiently effective

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion across the European Union. These products are used as plasma volume replacement following acute (sudden) blood loss, where treatment with alternative products known as ‘crystalloids’ alone is not considered to be sufficient.

The review was triggered by results from two drug utilisation studies indicating that HES solutions are being used in critically ill patients and those with sepsis and kidney injury despite restrictions introduced in 2013 to reduce the risks of kidney problems and deaths in these patient populations.

In 2013, the PRAC had recommended restrictions on the use of HES solutions, including that they must no longer be used to treat critically ill patients or patients with sepsis, because of an increased risk of kidney injury and mortality seen in clinical trials. The Committee requested that further studies be carried out to verify adherence to these restrictions.

The PRAC has reviewed the results from the drug utilisation studies of HES solutions for infusion together with the currently available data on benefits and risks from clinical trials and observational studies and feedback received from stakeholders and experts. Based on this review, the PRAC has concluded that the restrictions introduced in 2013 have not been sufficiently effective. The Committee explored the possibility of introducing additional measures but concluded that such measures would be ineffective or insufficient.

In view of the serious risks that certain patient populations are exposed to, the PRAC has recommended the suspension of the marketing authorisations for HES solutions. Alternative treatment options are available.

The PRAC recommendation will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)1 for consideration at its meeting on 22-25 January 2018.

For more information:

Hydroxyethyl starch (HES) containing medicinal products


1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.

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