Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2018
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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
Recommendation by PRAC
| Hydroxyethyl starch (HES) containing medicinal products |
|---|
Article 107i referral: Hydroxyethyl starch (HES) containing medicinal products Hydroxyethyl starch Article-107i referral - Summary of PRAC recommendation |
Ongoing referrals
| Procedure | Status | Update |
|---|---|---|
| Article-20 procedure: Esmya | Under evaluation | PRAC continued its assessment |
| Article-31 referral: Flupirtine-containing medicinal products | Under evaluation | PRAC continued its assessment |
| Article-31 referral: Retinoid-containing medicinal products | Under evaluation | PRAC continued its assessment |
| Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal products | Under evaluation | PRAC continued its assessment |
| Article-31 referral: Valproate and related substances | Under evaluation | PRAC continued its assessment |
| Article-20 procedure: Xofigo | Under evaluation | PRAC continued its assessment |