A new Danish study published in the New England Journal of Medicine has investigated HES used as a plasma substitute in patients with severe sepsis.
The study followed 800 patients from intensive care units in Denmark, Iceland, Norway and Finland over a two-year period.
The conclusions of the study suggest that HES has a less favourable safety profile than Ringer's acetate used as plasma substitutes in patients with severe sepsis.
The Danish Health and Medicines Authority (DHMA) is aware of and has forwarded the new data to the German authorities, which coordinate the safety assessments for this medicine.
In cooperation with the other EU authorities, the DHMA will thus assess the new study together with the other available data to decide if the new data should lead to changes to the product information, including the recommendations for use of HES in the studied population.
The new study: Hydroxyethyl Starch 130/0.4 versus Ringer's Acetate in Severe Sepsis (New England Journal of Medicine)