The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that hydroxyethyl-starch (HES) solutions for infusion be taken off the market across Europe because previously announced measures that were put in place to protect patients have not been effective.
Infusion solutions containing HES are frequently used for volume replacement in various clinical settings. Crystalloids and colloids are the two main types of medicines used for volume replacement. Colloids contain large molecules, such as starch, whereas crystalloids, such as saline solutions or Ringer acetate, contain smaller molecules.
In 2013, as reported by Medscape Medical News, the PRAC recommended restrictions on the use of HES solutions ― namely, that they no longer be used to treat patients with sepsis or burn injuries or critically ill patients because of an increased risk for kidney injury and death. At the time, the PRAC requested that further studies be carried out to verify adherence to these restrictions.
A subsequent PRAC review of available data, including drug utilization studies of HES solutions for infusion, showed that “restrictions introduced in 2013 have not been sufficiently effective,” the EMA said in a statement issued January 12.
“The review was triggered by results from two studies indicating that HES-containing medicines were still being used in critically ill patients and those with sepsis and kidney injury despite restrictions introduced in 2013 to reduce the risks of kidney problems and deaths,” the EMA said.
The PRAC explored the possibility of introducing additional measures but concluded that such measures would be ineffective or insufficient.
“In view of the serious risks that certain patient populations are exposed to, the PRAC has recommended the suspension of the marketing authorizations for HES solutions. Alternative treatment options are available,” the EMA said.
The PRAC recommendations will be sent to the Coordination Group for Mutual Recognition and Decentralized Procedures–Human for consideration at its upcoming meeting on January 22 to 25, 2018.
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