Recommendation to Suspend Marketing Authorisations for HES Solutions to be Re-examined

On 13 June 2013, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded following a review of the available evidence that the benefits of infusion solutions containing hydroxyethyl-starch (HES) no longer outweigh their risks and therefore recommended that the marketing authorisations for these medicines be suspended.

Following the PRAC recommendation, some of the marketing authorisation holders requested a re-examination. Upon receipt and validation of the grounds, the PRAC will re-examine its recommendation and issue a final recommendation.

Infusion solutions containing HES are medicines mainly used to replace lost blood volume in hypovolaemia (low blood volume caused by dehydration or blood loss) and hypovolaemic shock (a steep fall in blood pressure caused by drop in blood volume). They are used in critically ill patients including patients with sepsis (bacterial infection of the blood) or burn or trauma injuries, or patients who are undergoing surgery.

The review of infusion solutions containing HES was triggered by the German medicines agency, the Federal Institute for Drugs and Medical Devices ( BfArM ), following three recent studies1 , 2 , 3 that compared HES with other products used for volume replacement called crystalloids in critically ill patients. The studies showed that patients with severe sepsis treated with HES were at a greater risk of kidney injury requiring dialysis. Two of the studies1,2 also showed that in patients treated with HES there was a greater risk of mortality. The PRAC was therefore requested to assess the available evidence and how it impacts on the risk - benefit balance of HES infusion solutions in the management of hypovolaemia and hypovolaemic shock.

The PRAC assessed data from the scientific literature and the data submitted by the companies, and took advice from a group of external experts. The PRAC was of the opinion that, when compared with crystalloids, patients treated with HES were at a greater risk of kidney injury requiring dialysis and had a greater risk of mortality. The PRAC also considered that the available data only showed a limited benefit of HES in hypovolaemia, which did not justify its use considering the known risks. The PRAC therefore concluded that the marketing authorisations for these medicines be suspended. The Committee considered that the suspension should remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.

The PRAC recommendation will now be re-examined and the outcome will be made public on the EMA website.

Source: European Medicines Agency (EMA)

References:

  1. Perner, A. et al. Hydroxyethyl Starch 130/0.42 versus Ringer’s acetate in severe sepsis. N Engl J Med 20 12; 367(2):124 - 134.
  2. Brunkhorst, F.M. et al. Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med, 2008; 358(2):125 - 39.
  3. Myburgh, J.A. et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care; N Eng l J Med 2012; 367(20):1901 - 11.

Published on : Mon, 22 Jul 2013


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On 13 June 2013, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded following a review of the available evidence that the benefits of i

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