The use of starch drips
to treat critically ill patients and those undergoing surgery is to be suspended
in the UK because their benefits no longer outweigh the risk of using them, the
Medicines and Healthcare products Regulatory Agency (MHRA) announced
today.
The drips are currently
used in a range of clinical settings for treatment and prevention of low blood
volume (hypovolaemia) and a steep drop in blood pressure (hypovolaemic shock),
as well as for maintenance of adequate circulation during surgical procedures,
should no longer be used.
Dr Sarah Branch, Deputy
Director of the MHRAs Vigilance and Risk
Management of Medicines Division said:
The use of these types of drips has
fallen in the last year because of published evidence which shows that there is
an increased risk associated with the use of hydroxyethyl starch products
compared with simple salt solutions (crystalloids).
Having considered the available
evidence, and taken advice from the Commission on Human Medicines, we have
decided to suspend their use in the UK.
Professor Julian Bion,
Dean of the Faculty of Intensive Care Medicine said:
'The decision to suspend the use of HES
products, and the recommendation to use crystalloid solutions for fluid
resuscitation, are supported by the Faculty of Intensive Care Medicine, the
Intensive Care Society, and the Royal College of Anaesthetists. We have issued a
position statement and guidance for our members on our respective
websites.
The risks and benefits
of starch drips are the subject of an EU wide review following the publication
of studies which suggested an increased risk of renal injury and death in
patients treated with these products compared with crystalloids (simple salt
solutions).
The decision follows a
recommendation by European Medicines Agency (EMA) and a review of the evidence
by the MHRAs independent expert group the Commission on Human Medicines (CHM) - which
found that the benefits of their use no longer outweighed the risks.
The MHRA will issue
information to healthcare professionals to inform them of the decision and plans
for the recall of the product from the supply chain.
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