European Medicines Agency’s Pharmacovigilance Risk Assessment Committee Recommends Suspending Marketing Authorizations for Infusion Solutions Containing Hydroxyethyl Starch

On June 14, 2013, following a review of the available evidence, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of infusion solutions containing hydroxyethyl starch (HES) no longer outweigh their risks and therefore recommended that the marketing authorizations for these medicines be suspended.

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 studies [1-3] that compared HES with 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 studies [1, 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 hypovolemia and hypovolemic 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 hypovolemia, which did not justify its use considering the known risks. The PRAC therefore concluded that the marketing authorizations for these medicines be suspended.

The PRAC recommendation will be considered by the European Medicines Agency’s Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). The European commission will then take the final decision.

Source: European Medicines Agency [Link]

References

1. Perner A, Haase N, Guttormsen AB, et al. Hydroxyethyl starch 130/0.42 versus Ringer’s acetate in severe sepsis. N Engl J Med 2012;367:124-34.

2. Brunkhorst FM, Engel C, Bloos F, et al. Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med 2008;358:125-39.

3. Myburgh JA, Finfer S, Bellomo R, et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med 2012;367:1901-11.