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The EMA's Safety Committee, PRAC, recommended on 11 February 2022 the suspension of marketing authorisations for hydroxyethyl starch (HES) infusion solutions in the European Union, a statement said.
These products, it notes, were licensed as an add-on therapy for plasma volume replacement following acute (sudden) blood loss.
As noted, the safety of HES infusion solutions was evaluated in two separate procedures in 2013, and a number of restrictions and measures were implemented to minimise the risk of kidney injury and death in certain patients (those in critical condition, with burns or with sepsis, a bacterial infection in the blood).
(CNA)
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