EU authority: blood replacement severely restricted



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Blood substitute "hes" may only be used in exceptional cases

The controversial blood substitute Hes may only be used to a very limited extent in exceptional cases in the future. The European Medicines Agency decided that today. Studies had shown that hes can cause kidney damage. Proponents of blood replacement, however, criticized methodological errors in the studies. In addition, you fear that an appropriate substitute for the drug could not be found in the short term.

Hes blood replacement is said to favor kidney damage For months, doctors and other medical experts fought over the blood replacement Hes. The substance is administered to the patient in the form of an infusion solution in order to stabilize the circulation. As the Pharmacovigilance Risk Assessment Committee (Prac) of the European Medicines Agency Ema announced today, Hes may only be used in future in exceptional cases.

The agency evaluated the available studies on blood replacement and came to the conclusion that the drug can only be used under strict conditions. Patients with septicemia, burns, or critically ill patients at increased risk of renal dysfunction should no longer be treated with Hes. An exception are patients who suffer from insufficient blood volume (hypovolaemia) in the circulatory system due to acute blood loss. In such cases, the product may also be used in the future.

"The verification of the Hes infusions was originally initiated by the German drug authorities, 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 kidney damage to dialysis patients who were critically ill and were treated with hes infusions, ”says a Prac press release. The BfArM had already issued a recommendation for Hes since July, according to which the funds should no longer be used until the matter has been clarified.

For the medical background of Hes solutions Hes (hydroxyethyl starch) has so far been used as a colloidal volume replacement that can compensate for an intravascular lack of blood volume and thus stabilize the patient's circulation in an emergency. Hydroxyethyl starch is obtained from potato starch or waxy maize starch and is one of the large molecular 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 for up to a certain point and the given fluid is kept in the bloodstream longer. (ag)

Image: Andrea Damm / pixelio.de

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