EMA’s safety committee, PRAC, has recommended that the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union. These products were authorised as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss.
Hydroxyethyl starch: List of nationally authorised medicinal products
As the EMA’s recommendation to suspend HES solutions from the market heads to the European Commission for a final decision, scientists who were asked to provide independent advice say that they were completely ignored. Peter Doshi reports
Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation
has endorsed the recommendation to suspend the marketing authorisations of 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.