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Benefits no longer outweigh risks from starch IV drips, says EMA

The benefits of infusion solutions containing hydroxyethyl-starch (HES) no longer outweigh their risks, according to European regulators.

The European Medicines Agency has carried out a review of new research and recommended that marketing authorisations for starch drips be suspended as a result of its findings.

They have previously been 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 EMA review, carried out by a committee responsible for evaluating safety issues for medicines, looked at infusion solutions containing HES was triggered by three recent studies that compared HES with other products used for volume replacement called crystalloids in critically ill patients.

The studies showed that patients with severe sepsis treated with HES were at a greater risk of kidney injury requiring dialysis. Two of the studies also showed that in patients treated with HES there was a greater risk of mortality.

The review’s recommendations will now be assessed by a further EMA drugs regulatory committee, which will adopt a final position that could lead to a ban across EU member states.

Dr Sarah Branch, deputy director of the Medicines and Healthcare products Regulatory Agency’s vigilance and risk management of medicines division, said: “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.”

Last month the National Institute for Health and Care Excellence published draft guidance on IV, which advised against the use of tetrastarches. It is open for consultation until 3 July.

 

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