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FDA: Hydroxyethyl Starch Solutions Increase Risk of Severe Renal Injury, Bleeding

ROCKVILLE, Md -- June 25, 2013 -- The US Food and Drug Administration has analysed recent data that indicate that hydroxyethyl starch solutions (HES) is associated with an increased risk of mortality and renal injury requiring renal replacement therapy in critically ill adult patients, including patients with sepsis and those admitted to the intensive care unit (ICU); and excess bleeding particularly in patients undergoing open heart surgery in association with cardiopulmonary bypass.

The FDA has concluded that HES solutions should not be used in critically ill adult patients, including patients with sepsis and those admitted to the ICU, and a Boxed Warning to include the risk of mortality and severe renal injury is warranted.

In addition, the FDA has reviewed a meta-analysis of studies conducted in patients undergoing open heart surgery in association with cardiopulmonary bypass and has determined that an additional warning about excessive bleeding is needed in the Warnings and Precautions Section of the package insert.

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