Das Pharmacovigilance Risk Assessment Committee (PRAC) der EMA hat in seiner Sitzung vom 7-10 Oktober 2013 folgende differenzierende Empfehlung zum weiteren Umgang mit Hydroxyethylstärke (Hes) beschlossen:...
Das Pharmacovigilance Risk Assessment Committee (PRAC) der EMA hat in seiner Sitzung vom 7-10 Oktober 2013 folgende differenzierende Empfehlung zum weiteren Umgang mit Hydroxyethylstärke (Hes) beschlossen:(siehe www.ema.europa.eu/ema)
"PRAC confirms that hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically-ill patients
The PRAC has completed its review of hydroxyethyl-starch (HES) solutions following an assessment of new information and commitments from companies for additional studies and risk minimisation activities. The Committee confirmed that HES solutions must no longer be used to treat patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients, because of an increased risk of kidney injury and mortality. HES solutions may, however, continue to be used in patients to treat hypovolaemia (low blood volume) caused by acute blood loss, provided that appropriate measures are taken to reduce potential risks and that additional studies are carried out...
A link to more information on the reviews of CHCs and HES is available in the table below.
The PRAC recommendation will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), for consideration at its meeting on 21-23 October 2013."