Open letter to the Executive Director of the European Medicines Agency concerning the licensing of hydroxyethyl starch solutions for fluid resuscitation

摘要

Editor-We have sent this letter to the Executive Director of the European Medicines Agency: we are concerned that the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee's (PRAC) recent conclusions on the use of hydroxyethyl starch (HES) will result in harm to patients. In June, the PRAC recommended the suspension of marketing authorization for HES, as the available evidence demonstrated that any possible benefits from HES no longer outweigh its risk. On October 11, 2013, the PRAC revised its conclusions, announcing that 'HES must no longer be used to treat patients with sepsis or burns injuries or in critically ill patients because of an increased risk of kidney injury and mortality. HES solutions may, however, continue to be used in patients to treat hypovolaemia caused by acute blood loss, provided that appropriate measures are taken to reduce potential risks and that additional studies are carried out'.