The European Medicines Agency has confirmed that hydroxyethyl-starch solutions should no longer be used to treat patients with sepsis, burn injuries or critically ill patients.
The agency’s Pharmacovigilance Risk Assessment Committee has conducted a full review of the evidence on use of the solutions in response to studies suggesting a link with an increased risk of kidney injury and mortality.
A temporary ban on the use of the products was announced in June. However, following the review the committee has concluded the solutions, which are a form of colloid, can be used 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.
It recommended the solutions should not be used for more than 24 hours and that patients’ kidney function should be monitored for at least 90 days.