Europe recommends ban on common plasma substituteBMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3942 (Published 17 June 2013) Cite this as: BMJ 2013;346:f3942
The European Medicine Agency has suspended the marketing authorisation for infusion solutions containing hydroxyethyl starch, saying that their benefits no longer outweigh their risks. In the United Kingdom the Medicines Healthcare Products Regulatory Agency is reviewing the evidence and will make a decision next week.
Starch drips are mainly used to replace lost blood volume in hypovolaemia and hypovolaemic shock. They are used in critically ill patients such as those with sepsis, burn, or trauma injuries and patients undergoing surgery.
The move comes after three recent studies showing that patients with severe sepsis who were treated with hydroxyethyl starch were at greater risk of kidney injury requiring dialysis than patients who were treated with crystalloids.1 2 3
Two of the studies also showed that patients treated with hydroxyethyl starch were at greater risk of mortality.
In February this year a meta-analysis published in JAMA concluded that hydroxyethyl starch was associated with an increased risk of death and acute kidney injury in critically ill patients. The meta-analysis had excluded trials conducted by Joachim Boldt, whose research had been retracted because of scientific misconduct.4
Boldt, a prominent German anaesthetist, was an advocate of the use of colloids, particularly hydroxyethyl starch. After a lengthy investigation 88 of his research papers were withdrawn from the medical literature after he was found guilty of research misconduct, including failure to acquire ethical approval and fabrication of study data.5
The European Medicines Agency’s Pharmacovigilence Risk Assessment Committee carried out the review at the request of Germany’s drugs agency. The committee concluded that the suspension should remain in place unless the marketing authorisation holder could provide convincing data to identify a group of patients in whom the benefits of starch solutions outweighed the risks.
Hydroxyethyl starch is available in all European countries under various trade names.
Sarah Branch, deputy director of the MHRA’s Vigilance and Risk Management of Medicines Division, said that the NHS’s use of starch drips had fallen after publication of studies indicating safety concerns. She said, “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.”
Cite this as: BMJ 2013;346:f3942