Hydroxyethyl starch (Voluven and Volulyte) - Update

Increased risk of death and kidney injury in critically ill patients

A subsequent review of the safety issue relating to hydroxyethyl starch-containing medicines has resulted in an updated safety advisory.

In addition to the potential risks for patients with sepsis (see link below), the updated review found that the increased risk of death and kidney injury that may need kidney replacement therapy (such as dialysis) applies to all critically ill patients, such as those typically admitted to the intensive care unit of a hospital.

In response to the new information, the TGA has been working closely with Fresenius Kabi Australia, the sponsor of the two hydroxyethyl starch products, Voluven and Volulyte, to update the Product Information (PI) for these medicines.

The TGA will continue to monitor this issue. For more information see here.
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