Three haemorrhage drugs to be banned in Spain

The Spanish Agency for Medicines and Health Products (AEMPS) has announced that three drugs containing hydroxyethyl starch will be banned from Thursday 15 December. The medicines are used to treat hypovolaemia caused by acute haemorrhage when crystalloid solutions cannot be used. The ban effects Isohes, Volulyte and Voluven. Stocks available in healthcare facilities must be returned.

AEMPS had already announced at the end of June that it would take such a measure in Spain. The European Pharmacovigilance Risk Assessment Committee (PRAC) has on several occasions reviewed the benefit/risk balance of hydroxyethyl-starch products and concluded that the risks associated with their use was high and called for the suspension of their marketing authorisation in all EU countries.

The PRAC's recommendation was endorsed by the European Commission, which published its decision on 24 May.