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South African critical care experts have appealed to the Medicine Control Council to reconsider its ban on life saving new generation ICU starch drip fluids.
Speaking on the sidelines of the 11th Congress of the World Federation of Societies of Critical Care Medicine in Durban today Dr Ivan Joubert head of critical care at the University of Cape Town said experts had appealed via letters in medical journals for the MCC to remove the ban. The MCC had also issued a product recall in August.
Joubert, speaking on behalf of several local experts from across the country said the MCC had over-reacted to an EU Medicine’s Agency's, Pharmacovigilance Risk Assessment Committee (PRAC) recommendation to suspend market authorisation of the widely used hydroxyethl starches. It said the starch drips were more likely to cause death or kidney damage than saline solution alternatives.
The doctors, all associated with the SA Society of Aneasthesiologists and the SA Society of Critical Care raised their concern in letters published in the SA Medical Journal and the SA Journal of Anaesthesia and Analgesia recently.
Hydroxyethyl starch drips are a new generation of colloid drugs used to improve blood volume in dehydrated patients, those who have lost a lot of blood, or who have experienced a sharp drop in blood pressure. The drugs are also used in ICU to treat patients with bacterial blood infections, those who are undergoing surgery and for trauma and burn victims.
The benefits of colloids
Joubert said the benefit of colloids was that they were more like blood than the alternative, crystalloid solutions, and had the ability to remain in the intravascular space (the space inside the blood vessels) to provide a better and more lasting expansion of blood volumes.
Joubert said the meta-analysis that the EU regulator had used to inform its recommendation was “flawed” because it had drawn data from studies on the older forms of the drugs and cases where it was not indicated. He said research on the use of hydroxyethyl starches spanned 40 years.
“They are removing them based on pools of data from studies which includes a wealth of information from the old starches which is crazy. Unfortunately, they have used different starches and different indications for therapy,” Joubert said.
“The MCC made the decision and they haven’t listened to the expertise in the country. As clinicians we have really grave concerns in that the most recent advanced available therapy has been taken away from us and the alternatives that we have are all older drugs. We have evidence that those older fluids are not better,” Joubert said.
“There are a number of experts in the field in the country from all centres who have appealed that the MCC reconsider the decision,” Joubert said.
Greater risk of complications
Joubert said consequences for patients were that doctors now had to use less effective resuscitation solutions in ICUs, which could lead to a greater risk of complications.
He said hydroxyethyl colloids resulted in the more rapid resuscitation, or stabilization of patients, which reduced complications and saved lives.
“There has been no response from the MCC, our hands are tied,” Joubert said.
Immediate past professor and head of the Department of Anaesthesia at UCT, Michael James, said his SA study called Fluids in Resuscitation of Severe Trauma (The First Study) had shown the distinct advantage of hydroxyethyl colloids over crystalloids in penetrating trauma – gun shot and stab wounds – which are the greatest trauma injuries in the country.
“The incidence of kidney injury in the starch group in my study was zero compared to 17 percent in the saline group but that was because the patients needed volume resuscitation.”
“In peri-operative and trauma use there is absolutely zero evidence that these products are harmful. Those of us that wish to retain them realise that it is being badly used in intensive care and that these studies have certainly shown us that we should not be using colloids after the initial resuscitation. They have shown us a limited window on practice,” James said.
James added that three countries had banned the use of colloids – Poland, Italy and the UK – but that Poland had yesterday announced it would continue to use the drugs. James is among several local experts who have written to the EU’s PRAC objecting to its recommendation.
(Picture: IV drip from Shutterstock)
Speaking on the sidelines of the 11th Congress of the World Federation of Societies of Critical Care Medicine in Durban today Dr Ivan Joubert head of critical care at the University of Cape Town said experts had appealed via letters in medical journals for the MCC to remove the ban. The MCC had also issued a product recall in August.
Joubert, speaking on behalf of several local experts from across the country said the MCC had over-reacted to an EU Medicine’s Agency's, Pharmacovigilance Risk Assessment Committee (PRAC) recommendation to suspend market authorisation of the widely used hydroxyethl starches. It said the starch drips were more likely to cause death or kidney damage than saline solution alternatives.
The doctors, all associated with the SA Society of Aneasthesiologists and the SA Society of Critical Care raised their concern in letters published in the SA Medical Journal and the SA Journal of Anaesthesia and Analgesia recently.
Hydroxyethyl starch drips are a new generation of colloid drugs used to improve blood volume in dehydrated patients, those who have lost a lot of blood, or who have experienced a sharp drop in blood pressure. The drugs are also used in ICU to treat patients with bacterial blood infections, those who are undergoing surgery and for trauma and burn victims.
The benefits of colloids
Joubert said the benefit of colloids was that they were more like blood than the alternative, crystalloid solutions, and had the ability to remain in the intravascular space (the space inside the blood vessels) to provide a better and more lasting expansion of blood volumes.
Joubert said the meta-analysis that the EU regulator had used to inform its recommendation was “flawed” because it had drawn data from studies on the older forms of the drugs and cases where it was not indicated. He said research on the use of hydroxyethyl starches spanned 40 years.
“They are removing them based on pools of data from studies which includes a wealth of information from the old starches which is crazy. Unfortunately, they have used different starches and different indications for therapy,” Joubert said.
“The MCC made the decision and they haven’t listened to the expertise in the country. As clinicians we have really grave concerns in that the most recent advanced available therapy has been taken away from us and the alternatives that we have are all older drugs. We have evidence that those older fluids are not better,” Joubert said.
“There are a number of experts in the field in the country from all centres who have appealed that the MCC reconsider the decision,” Joubert said.
Greater risk of complications
Joubert said consequences for patients were that doctors now had to use less effective resuscitation solutions in ICUs, which could lead to a greater risk of complications.
He said hydroxyethyl colloids resulted in the more rapid resuscitation, or stabilization of patients, which reduced complications and saved lives.
“There has been no response from the MCC, our hands are tied,” Joubert said.
Immediate past professor and head of the Department of Anaesthesia at UCT, Michael James, said his SA study called Fluids in Resuscitation of Severe Trauma (The First Study) had shown the distinct advantage of hydroxyethyl colloids over crystalloids in penetrating trauma – gun shot and stab wounds – which are the greatest trauma injuries in the country.
“The incidence of kidney injury in the starch group in my study was zero compared to 17 percent in the saline group but that was because the patients needed volume resuscitation.”
“In peri-operative and trauma use there is absolutely zero evidence that these products are harmful. Those of us that wish to retain them realise that it is being badly used in intensive care and that these studies have certainly shown us that we should not be using colloids after the initial resuscitation. They have shown us a limited window on practice,” James said.
James added that three countries had banned the use of colloids – Poland, Italy and the UK – but that Poland had yesterday announced it would continue to use the drugs. James is among several local experts who have written to the EU’s PRAC objecting to its recommendation.
(Picture: IV drip from Shutterstock)
