Following the European Medicines Agency’s (EMA) recommendation to suspend of the marketing authorisations of hydroxyethyl starch (HES) solutions across the European Union (EMA, 2018), Roberts et al., have written an open letter addressed to the World Health Organization (WHO) Director General seeking support for the suspension of HES solutions and expanding it to a worldwide ban.
Investigator-initiated clinical trials in kidney donors, patients with sepsis, and critically ill patients revealed that HES solutions are associated with serious adverse events and no patient benefits (Myburgh et al., 2012). Considering a previous restriction put in place in 2013 was not being observed in many countries and HES solutions continued to be used in prohibited populations, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recently recommended the suspension of the marketing authorisation of HES solutions across the European Union (EMA, 2018).
Current WHO guidelines follow a similar recommendation for the prevention and treatment of post-partum haemorrhages; crystalloids are to be used in preference to colloids for the resuscitation of women with post-partum haemorrhage (WHO, 2017). However, during the WOMAN trial, the researchers became aware that many women with post-partum haemorrhage are still being treated with colloids, in particular HES solutions (WOMAN Trial Collaborators, 2017).
With the possible suspension of HES solutions on the horizon in Europe, the authors expressed concerns that intensified marketing efforts will now be made in low- and middle-income countries. With the WHO uniquely positioned to address these global issues, the authors called on them to protect vulnerable patients around the world and ban the use of HES solutions.
Update: In July 2018 the European Commission took the EU-wide, legally binding decision to continue the marketing of HES under new restrictions. Learn more about these restrictions and how the decision was made with our interactive HES timeline.
Catch-up on the debate surrounding hydroxyethyl starch use as we take you on an interactive journey through its changing fortunes. Do you think current restrictions will be enough to change clinical practice?
European Medicines Agency, 2018. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Hydroxyethyl_starch_(HES)_containing_medicinal_products/human_referral_prac_000068.jsp&mid=WC0b01ac05805c516f (accessed April 2018).
Myburgh JA, Finfer S, Bellomo R, Billot L, Cass A, Gattas D, et al. Hydroxyethyl Starch or Saline for Fluid Resuscitation in Intensive Care. N Eng J Med. 2018;367:1901–11.
WHO. WHO recommendation on tranexamic acid for the treatment of postpartum haemorrhage. Geneva: World Health Organization; 2017.
WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017;389:2105–16.
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Following the European Medicines Agency’s (EMA) suspension of the marketing authorisations of hydroxyethyl starch (HES) solutions across the European Union (EMA, 2018), Roberts et al., have written an open letter addressed to the World Health Organization (WHO) Director General seeking support for the suspension of HES solutions and expanding it to a worldwide ban.
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