Hydroxyethyl starch (Voluven and Volulyte)

Safety advisory - increased risk of mortality and the need for dialysis in patients with sepsis

4 April 2014

Consumers and health professionals are advised that a recent safety review of hydroxyethyl starch has found an increased risk of mortality and the need for dialysis when this medicine is used to treat patients with sepsis.

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

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

Prior to undertaking the full safety review, the TGA published a monitoring communication for hydroxyethyl starch as part of its Early Warning System.

Since then, the TGA has worked with the Australian sponsor of Voluven and Volulyte, Fresenius Kabi Australia, to update the Product Information (PI) for these medicines. The updated PI, which included new contraindications for 'patients with sepsis' and 'patients with severe liver disease', as well as updated information in the precautions and dosage and administration sections, was approved on 12 July 2013.

The TGA's safety review, which considered information provided by Fresenius Kabi Australia and open literature regarding the safety of hydroxyethyl starch, found that the updates in the PI regarding patients with sepsis were sufficient to mitigate the identified risks.

For non-septic patients, no evidence of increased risk of mortality or the need for dialysis was identified.

The TGA will continue to monitor this issue.

Information for health professionals

Health professionals should ensure that they are familiar with the current PI for hydroxyethyl starch. In particular, note that this medicine is now contraindicated for patients with sepsis and patients with severe liver disease.

Hydroxyethyl starch should be discontinued at the first sign of renal injury or if 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.

If a patient is concerned about this issue, reassure them that the PI update addresses the above risks.

Information for consumers

Hydroxyethyl starch is used in very specific circumstances, most commonly in hospitals during surgery and in other circumstances where there is a sudden drop in blood pressure and intravenous fluid replacement is required.

The PI update, including ruling out use of this medicine for patients with sepsis, addresses the above risks.

If you have any concerns about this issue, talk to 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.