Hetastarch 6% in saline - HESPAN

Do not use in critically ill adults, including sepsis, because of mortality and renal-replacement-therapy risk. Avoid pre-existing renal dysfunction and stop at the first sign of renal injury. Monitor renal function for at least 90 days after administration in hospitalized patients. Renal disease with anuria or oliguria not related to hypovolemia is contraindicated.

This 2015 source is historical and must be read with the separately stored FDA 2021 safety expansion. It supplies restrictions and monitoring, not a safe reduced-dose regimen for renal impairment.

FDA required expanded boxed warnings for hydroxyethyl starch products in July 2021. The risks include mortality, acute kidney injury including renal-replacement therapy, and excess bleeding in surgical patients, plus mortality and acute kidney injury in blunt-trauma patients. FDA advises against use unless an adequate alternative treatment is unavailable.

This safety action extends beyond an older warning limited to critically ill adults or sepsis. It is a regulatory restriction, not a renal dose-reduction strategy or proof that reduced exposure avoids the risk.