SSAI statement supports the suspension of HES solutions by the EMA
March 8, 2018
The European Medicine Agency has decided to suspend Hydroxyethyl-Starch (HES) because of serious side-effects in specific patient groups:
This decision has obviously led to some discussion, especially among those who have continued to use HES despite concerns about safety.
This discussion has resulted in a formal letter from the German Society of Anaesthesiology and Intensive Care Medicine (DGAI) urging all European Anaesthesia Societies to argue to the European comission against suspension of HES solutions. This letter was sent to the majority European national societies of anaesthesiologists, to the European Society of Anaesthesia Council members and to the WFSA.
The position of the SSAI and all National member societies is opposite to the German proposition and on March 8th 2018 the SSAI has issued a collective statement:
“The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI) fully supports the recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) to suspend the marketing authorisation of hydroxyethyl-starch (HES).”
The SSAI has established a task force working group who will argue for the position of the SSAI on a scientific basis. The concise statement will be published in Acta Anaesthesiologica Scandinavica within a short time.