Hydroxyethyl starch (Voluven and Volulyte) and increased risk of mortality

Updated monitoring communication

4 April 2014

The TGA has completed its safety review of hydroxyethyl starch. A safety advisory regarding the increased risk of mortality and the need for dialysis, which is based on the findings of this review, has been published on the TGA website.

Hydroxyethyl starch is a medicine used in clinical situations, including during surgery, to treat and prevent a condition known as hypovolaemia.

In Australia, two products are registered on the Australian Register of Therapeutic Goods (ARTG) which contain hydroxyethyl starch - Voluven and Volulyte.

Recent publications have indicated the use of hydroxyethyl starch is associated with an increased risk of mortality as well as an increased risk of requiring dialysis when used in certain patient populations, in particular, in patients with sepsis.

In addition, the United States Food and Drug Administration, Health Canada, and the United Kingdom's Medicines and Healthcare products Regulatory Agency have released public statements regarding the use of hydroxyethyl starch.

TGA response

The TGA has commenced a full risk benefit review of products containing hydroxyethyl starch.

In the meantime, the TGA is working with Fresenius Kabi, the sponsor of the products, to update the Product Information documents for Voluven and Volulyte to add contraindications for use in sepsis and in patients with severe liver disease. Furthermore, the wording in the Precautions section regarding the increased risk of severe renal impairment and bleeding disorders will be strengthened.

Information for health professionals

At this time, health professionals are advised not to use hydroxyethyl starch in patients with sepsis, renal failure including those requiring dialysis, severe liver failure, fluid overload, severe hyperchloraemia or hypernatraemia, patients with intracranial bleeding, and in patients with a known hypersensitivity to hydroxyethyl starch.

Health professionals should also be aware of the following:

  • Use of hydroxyethyl starch should be discontinued at the first sign of renal impairment. The need for dialysis has been reported up to 90 days after the use of hydroxyethyl starch.
  • Bleeding disorders, greater than those explained by dilutional effects of volume replacement, have been noted with the use of these products. Hydroxyethyl starch should be discontinued if a coagulopathy is detected.
  • Use in critically ill patients should only be considered if other therapies have failed, the lowest possible dose is chosen, and the benefits outweigh the risk.

Health professionals are asked to report any serious adverse events including cases of renal impairment or bleeding disorders associated with the use of hydroxyethyl starch to the TGA. Information on how to report can be found below.

Information for consumers

Consumers are advised that hydroxyethyl starch is used in operating theatres and in other circumstances where there is a sudden drop in blood pressure and intravenous fluid replacement is required.

If you have any concerns about intravenous fluids that you or someone you know have been given, please talk to your doctor.

This monitoring communication highlights both known and potential safety concerns. If you have any questions or concerns about a therapeutic product you are using, please contact your health professional.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.

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