Abstract
After a safety review of hydroxyethyl starch (HES) solutions in 2013, restrictions on the use of HES were introduced in the European Union (EU) to reduce the risk of kidney injury and death in certain patient populations. Similar restrictions were introduced by the Food and Drug Administration in the United States and other countries. In October 2017, a second safety review of HES solutions was triggered by the European pharmacovigilance authorities based on a request by the Swedish Medical Products Agency to completely suspend HES. After several meetings and repeated evaluations, the recommendation to ban HES was ultimately not endorsed by the responsible committee; however, there was a vote for more restricted access to the drug and rigorous monitoring of policy adherence. This review delineates developments in the European pharmacovigilance risk assessment of HES solutions between 2013 and 2018. In addition, the divergent experts' opinions and the controversy surrounding this official assessment are described. As the new decisions might influence the availability of HES products for veterinary patients, potential alternatives to HES solutions, such as albumin solutions and gelatin, are briefly discussed.
Highlights
After a safety review of hydroxyethyl starch (HES) solutions in 2013, restrictions on the use of HES were introduced in the European Union (EU) to reduce the risk of kidney injury and death in certain patient populations
First introduced in the 1960s, hydroxyethyl starch (HES) rapidly became the most commonly used synthetic colloid in human intensive care units (ICUs) throughout the world, with over 60 products registered in Europe and four in the United States (US) by the year 2010 [1,2,3]
A recent abstract presented a controlled hemorrhagic shock model in anesthetized dogs treated with a bolus of either 6% tetrastarch, 4% succinylated gelatine, fresh whole blood, or an isotonic crystalloid, HES did not lead to a greater incidence of acute kidney injury (AKI) compared to the other resuscitations fluids [107]
Summary
EMA, European Medicines Agency; FDA, United States Food and Drug Administration. trauma patients receiving HES [54]. The new PRAC recommendation and CMDh position were referred back to the EMA by the European Commission in April 2018, as the concern regarding unmet medical needs (e.g., no safe alternative to HES solutions) and the feasibility and effectiveness of risk minimization measures (e.g., changes to the product information, direct health care professional communication) had not been adequately addressed [38] (Table 1). The PRAC stated that the benefits of HES solutions did not outweigh the risks, its continued use raised important public health concerns, and current risk minimization measures (e.g., information on the package insert) were inadequate [40] This time, the CMDh disagreed with the conclusions of the PRAC and decided that HES products should not be withdrawn from the market in June 2018 [41] (Table 1). At the time of writing this review and to the authors’ knowledge, no new regulations beyond the 2013/2014 restrictions have been published from non-EU countries, such as Canada, US, Australia, New Zealand, and Switzerland
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