For over 60 years the safety of hydroxyethyl starch (HES) and its use have been debated, with many physicians arguing that the fluid has serious adverse events and is often misused. The European Medicines Agency (EMA) took the decision to increase restrictions on the use of HES in June 2018, however, some have called for a total ban and feel patient safety is at risk. Controversies around coagulation impairment and tissue storage effects were reported shortly after HES introduction into a clinical setting. Two recent letters to editor by Jon Henrik Laake and Frederico Bilotta, have highlighted the evidence to date and explored the events that have occurred in the build-up to the recent EMA decision (Bilotta et al., 2018; Laake & Møller, 2018). You can see how these events and studies have shaped current views and practices of HES therapy by clicking on the years in the interactive timeline below.
Increasing reports of von Willebrand disease, disseminated intravascular clotting, and histological lesions in patients treated with hydroxyethyl starch (HES) emerged between 1975–2003.
Growing research over the concerns of hydroxyethyl starch (HES) as a volume expander highlighted their unsuitability in 2012 in sub-group patient populations, particularly those with severe sepsis.
The year 2013 began with a large systematic review and meta-analysis reporting no adverse effects or increased mortality in surgical patients receiving tetrastarches, but ended with a contrasting decision made by the European Medicines Agency (EMA) to implement restrictions of hydroxyethyl starch (HES) solutions in patients with sepsis, burns, or who were critically ill.
The Europeans Medicines Agency (EMA) was met with a backlash of criticism following the restrictions made in 2013, with a number of experts and academics backing the criticism.
By now those that had criticised the European Medicines Agency’s (EMA’s) decision had gathered support from societies and petitions called for action.
Possibly the most significant criticism of the decision was also published in 2017 when two studies revealed the staggeringly high percentage of non-adherence to the 2013 restrictions of hydroxyethyl starch (HES) in critically ill patients.
Mixed responses came from the European Medicines Agency’s (EMAs) reconsideration of banning hydroxyethyl starch (HES) solutions from the European market, with critics claiming the decision would be based on politics rather than scientific evidence.
Despite support from a number of international societies and experts, and the EMAs PRAC recommending the proposed ban, the EMA made the decision to continue the marketing of HES under new restrictions, adding to the ongoing debate.
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