|Date:||27 June 2013|
|Subject:||MHRA suspends use of hydroxyethyl starch (HES) drips|
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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 MHRA’s 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 MHRA’s 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.
Notes to Editor
- Starch drips are used in critically ill patients including patients with sepsis (bacterial infection of the blood) or burn or trauma injuries, or patients who are undergoing surgery.
- The MHRA have issued a Class 2 Drug Alert to healthcare professionals: Class 2 Drug Alert (Action Within 48 Hours): Hydroxyethyl Starch (HES) products - B Braun Melsungen AG and Fresenius Kabi Limited (EL (13)A/18)
- Faculty of Intensive Care Medicine (external link)
- The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.