Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2018

News 12/01/2018

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.

Agenda

PDF iconAgenda - PRAC draft agenda of meeting 8-11 January 2018

Recommendation by PRAC

Hydroxyethyl starch (HES) containing medicinal products

Article 107i referral: Hydroxyethyl starch (HES) containing medicinal products

PDF iconSummary of recommendation

Ongoing referrals

ProcedureStatusUpdate
Article-20 procedure: EsmyaUnder evaluationPRAC continued its assessment
Article-31 referral: Flupirtine-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Retinoid-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Valproate and related substancesUnder evaluationPRAC continued its assessment
Article-20 procedure: XofigoUnder evaluationPRAC continued its assessment

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