EU authority blood substitution severely restricted

blood substitute „Hes“ may only be used in exceptional cases

11/10/2013

The controversial blood substitute Hes may be used in the future only very limited in exceptional cases in patients. This has been decided by the European Medicines Agency today. Studies had shown that Hes can cause kidney damage. Advocates of the blood substitute, however, criticized methodical errors in the studies. In addition, they fear that no adequate replacement for the funds could be found in the short term.

Blood substitute Hes is said to promote kidney damage
For months, doctors and other medical experts argued over the blood substitute Hes. The substance is administered to the patient in the form of an infusion solution in order to have a circulatory stabilizing effect. As the Pharmacovigilance Risk Assessment Committee (Prac) of the European Medicines Agency Ema announced today, Hes may be used in the future only in exceptional cases.

The agency evaluated the existing studies on the blood substitute and came to the conclusion that the drug may only be used under strict conditions. Patients with sepsis, burns or critically ill patients at increased risk for renal dysfunction should no longer be treated with Hes. An exception is made by patients who, due to an acute blood loss, are suffering from insufficient blood volume (hypovolemia). In such cases, the remedy may also be used in the future.

„The review of the Hes infusions was originally initiated by the German Medicines Agency, the German Federal Institute for Drugs and Medical Devices (BfArM), because studies showed an increased risk of death in patients with sepsis and an increased risk of renal damage in dialysis patients who were critically ill and treated with Hes infusions“, it says in a press release by Prac. The BfArM had already issued a recommendation for Hes since July, according to which the funds should not be used until the matter has been clarified.

To the medical background of Hes solutions
Hes (hydroxyethyl starch) has hitherto been used as a colloidal volume replacement that can compensate for intravascular blood volume deficiency and thus stabilize the patient's circulation in an emergency. Hydroxyethyl starch is made from potato starch or waxy maize starch and belongs to the large molecular weight substances. The advantage of Hes over purely crystalloid infusions is that the agent can maintain the colloid osmotic pressure in the bloodstream so that fluid loss is compensated to a point and the given fluid is held longer in the bloodstream. (Ag)

Picture: Andrea Damm