Notice of temporary suspension of the marketing authorisation for medicinal products containing hydroxyethyl starch (HES)
The European Commission has published a Decision concerning the suspension of marketing authorisation of medicinal products which contain the active substance hydroxyethyl starch (HES), following an assessment of the safety of their use. This Decision relates to medicinal products with the active substance hydroxyethyl starch (HES) approved in the Republic of Croatia.
In accordance with Article 3 of the EC Decision, a Member State may exceptionally defer the application of Article 1 for a period not exceeding 18 months from the date of adoption of the Decision. Following consultations with various stakeholders in the health system, it was concluded that the immediate suspension of marketing authorisations could have a negative impact on public health considerations in the Republic of Croatia, therefore the implementation of the EC Decision in Croatia will be postponed for a period of 18 months, in accordance with the conditions stated in Article 3 of the Decision.
The European Commission Decision concerning the marketing authorisations of medicinal products which contain the active substance hydroxyethyl starch (HES) is available here.
The decision was reached following an assessment in which EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded in February 2022 that the risks associated with the use of HES solutions for infusion outweigh their benefits and therefore the benefit-risk ratio. PRAC therefore recommended that the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union. The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) then adopted this recommendation.
These medicinal products were authorised as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss. The safety of HES solutions for infusion was reviewed earlier in several separate procedures, and a number of restrictions and measures to minimise the risk of kidney injury and death in certain patients (those critically ill, with burn injuries or with sepsis, a bacterial infection in the blood) were put in place at the time. However, the assessment found no adherence to the stated measures; therefore, the decision in question was made. More information is available here.
More about the medicinal products
HES solutions for infusion were authorised for the management of hypovolaemia (low blood volume) caused by acute blood loss where treatment with alternative infusion solutions known as ‘crystalloids’ alone is not considered to be sufficient.
HES solutions belong to a class of medicines known as colloids. Besides blood products, there are two types of medicines used for plasma volume replacement: crystalloids and colloids. Colloids contain large molecules such as starch, whereas crystalloids are solutions of low molecular weight substances and include saline and Ringer’s solutions.
In the Republic of Croatia, the following medicinal products containing hydroxyethyl starch have been approved through national procedure:
- Volulyte 6% otopina za infuziju
- Voluven 6% otopina za infuziju.