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EMA Recommends Suspending Hydroxyethyl-starch Infusion Solutions

The European Medicines Agency (EMA) has recommended the suspension of marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion across the European Union.

 

EMA Recommends Suspending Hydroxyethyl-starch Infusion Solutions

The decision follows a review by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) which was triggered by the results of two studies which indicated 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.

The PRAC reviewed the results of drug utilisation studies, available data on benefits and risks from clinical trials and observational studies, and feedback from stakeholders and experts. Based on the findings of the review, the PRAC has concluded that the restrictions introduced in 2013 have not been sufficiently effective. The committee explored the possibility of introducing additional measures but concluded that such measures would be ineffective or insufficient. In view of the serious risks that certain patient populations are exposed to, the PRAC has recommended the suspension of marketing authorisations for HES solutions.

The recommendation will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) for consideration at its meeting on 22-25 January 2018.

 

Source: univadis

 

EMA Recommends Suspending Hydroxyethyl-starch Infusion Solutions

 
 
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