Hydroxyethyl starch solutions and patient harm.

On Jan 26, 2018, the European Medicines Agency (EMA) suspended the marketing authorisations of hydroxyethyl starch (HES) solutions across the European Union.1 These intravenous solutions are often used for plasma volume replacement following acute blood loss. Evidence from highquality, investigator-initiated clinical trials in kidney donors, patients with sepsis, and in critically ill patients has shown that HES use is associated with serious adverse effects with no patient benefits.2 Results from experimental and clinical studies strongly suggest that the toxicity of HES is attributed to tissue storage and coagulopathy.3 HES-induced coagulopathy increases the risk of bleeding and the need for blood products in patients with sepsis, intensive care patients, and those undergoing major surgery.4 The EMA based the decision not only on evidence of harm, but also on the fact that the 2013 decision to restrict the use of HES to non-septic patients with haemorrhagic shock was not being observed in many countries. HES solutions continued to be used in prohibited populations. We know that WHO guidelines for the prevention and treatment of postpartum haemorrhage5 recommend that crystalloids are used in preference to colloids for the resuscitation of women with post-partum haemorrhage. Nevertheless, during the WOMAN trial6 we became aware that many women with post-partum haemorrhage receive colloids and, most often, HES. We are concerned that the suspension of HES use in Europe will lead to intensification of efforts to market HES in low-income and middle-income countries, and that this will mean vulnerable patients, particularly women with obstetric bleeding, will bear the highest burden as a consequence. This is a major global health issue, which the WHO is uniquely positioned to address. We seek the support of WHO to protect patients by banning the use of HES solutions worldwide.