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MHRA Statement on Hydroxyethyl Starch (HES) Containing Solutions

PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch

 

Dr. Sarah Branch, Deputy Director of the MHRAs Vigilance and Risk Management of Medicines Division said:

We are aware of the recommendations of the European Medicines Agency to suspend the use of starch drips starch drips used in a range of clinical settings for treatment and prevention of hypovolaemia (low blood volume) and hypovolaemic shock (a steep drop in blood pressure due to loss of circulating blood volume), as well as for maintenance of adequate circulation during surgical procedure. The use of these products as declined in the NHS following publication of studies suggesting safety concerns.

We will be carefully reviewing the implications of this recommendation for use of these products, in the UK taking into account the availability of alternative treatments. We will seek advice from our Commission on Human Medicines next week and will communicate any new advice to clinicians following the meeting.

EMA press release

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The Operating Theatre Journal, OTJ, is published monthly and distributed to every hospital operating theatre department in the UK. The distribution includes both the National Health Service and the Private Sector.

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