Summary Safety Review - Hydroxyethyl starch (VOLUVEN and VOLULYTE) - Assessing the Potential Risk of Acute Kidney Injury in Non-Critically Ill Patients

June 30, 2017

Product

Hydroxyethyl starch (Voluven and Volulyte)

Potential Safety Issue

Acute Kidney Injury (AKI) in non-critically ill patients

Key Messages

  • Hydroxyethyl starch is a drug authorized for sale in Canada to treat low blood volume (not enough fluid in the blood).
  • Health Canada first carried out a safety review in 2013 that found a higher risk of AKI and death when hydroxyethyl starch products are used in critically ill patients. This current review evaluated all available safety information on the risk of AKI in non-critically ill patients with the use of these products to see if this risk was present in this population of patients.
  • Health Canada’s review concluded that there was not enough information to establish a link between the use of hydroxyethyl starch products in non-critically ill patients and the risk of AKI. Health Canada has requested additional safety information from the manufacturer and will continue to monitor safety information of hydroxyethyl starch products as it becomes available.

Overview

In 2013, Health Canada reviewed the risk of kidney injury and death associated with hydroxyethyl starch products when used in critically ill patients and found an increased risk in these patients. This finding led to updates to the hydroxyethyl starch product information to include warnings about the risk of kidney injury and death in patients with low blood volume needing intensive or emergency care. At the time of that review, it was unclear if the risk of kidney injury and death also applied to non-critically ill patients, such as those with non-life threatening injuries or having a planned surgery. Health Canada had asked the manufacturer of hydroxyethyl starch products to provide all available safety information of these products when used in non-critically ill patients. This review is a follow-up assessment of all the available data on this risk.

Use in Canada

  • Hydroxyethyl starch is a drug authorized for sale in Canada to treat low blood volume.
  • Hydroxyethyl starch has been marketed in Canada since 2006 under the brand name Voluven and since 2011 under the brand name Volulyte. It is available as an intravenous solution.
  • Approximately 500,000 patients have been treated with Voluven or Volulyte in Canada since they were first marketed.

Safety Review Findings

  • At the time of the review, Health Canada had not received any Canadian reports of AKI associated with the use of hydroxyethyl starch products in non-critically ill patients.
  • This safety review looked at information from 7 international reports of AKI where hydroxyethyl starch products have been used in non-critically ill patients. In these reports, there was not enough information to establish a link between hydroxyethyl starch products and AKI, although a link could not be ruled out. Other risk factors, such as low blood volume, could have caused the condition.
  • Health Canada reviewed 13 published articles related to AKI with the use of hydroxyethyl starch products in non-critically ill patients. These articles included the results of studies and clinical trials. In 10 of the 13 studies and trials looked at, the methods used were not suitable to test for a link between Voluven or Volulyte and AKI in non-critically ill patients. The remaining 3 studies did not suggest hydroxyethyl starches were associated with an increased risk of AKI in non-critically ill patients.

Conclusions and Actions

  • Health Canada’s review concluded that there was not enough information to establish a link between the use of hydroxyethyl starch products in non-critically ill patients and the risk of AKI. Health Canada has requested additional safety information from the manufacturer as it becomes available.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of these health products.
  • Health Canada will continue to monitor safety information involving hydroxyethyl starch products, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, international adverse reaction reports and what is known about the use of these drugs both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

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