Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2018
PRAC concludes one safety review
PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended the suspension of the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion across the European Union. These products are used as plasma volume replacement following acute blood loss, where treatment with alternative products known as ‘crystalloids’ alone is not considered to be sufficient.
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.
More information is provided in the public health communication below.