European and US medical regulators restrict marketing and use of resuscitation fluid

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee has recommended the suspension of marketing of intravenous resuscitation fluids containing hydroxyethyl starch (HES).

On 24 June, the US Food and Drug Administration (FDA) issued a warning in the packaging on the use of HES for resuscitation in critically ill patients and in patients undergoing cardiac surgery.

Resuscitation fluids are used in critically ill patients including those with sepsis, burn or trauma, and in patients who are undergoing major surgery.

Of these resuscitation fluids, HES solutions are the most widely used, particularly in Europe and its use in Australia commenced in the late 2000s.

The rulings by the EMA and FDA were made following the publication of recent studies, including the Crystalloid vs. Hydroxyethyl Starch Trial (CHEST) that was conducted in Australia and New Zealand by the Australian and New Zealand Intensive Care Society Clinical Trials Group and The George Institute for Global Health. This large-scale study demonstrated that the use of HES  for resuscitation in intensive care patients was associated with no clinical benefit – in particular an increase in the use of kidney dialysis and increased risk of death.

Professor John Myburgh AO of The George Institute and the University of New South Wales commented that the move by the EMA and the FDA was an important step in ensuring that the results of high-quality research conducted by investigators are translated into clinical practice across the world.

“The selection of resuscitation fluid in critically ill patients requires careful consideration of its safety, its potential impact on patient-centred outcomes and its cost,” he said.

According to the EMA, the suspension should remain in place unless the marketing-authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks

For more about the suspension by the European Medicine’s Agency click here

For more about the packaging warning by the Food and Drug Administration click here