The U.S. Food and Drug Administration (FDA) has found data that indicate an increased risk of mortality and renal injury requiring renal replacement therapy in critically ill adult patients treated with hydroxyethyl starch (HES) solutions. HES solutions are used for the treatment of hypovolemia when plasma volume expansion is indicated. After a public workshop, the FDA concluded that HES solutions should not be used in this patient population, and a Boxed Warning to include the risk of mortality and severe renal injury is warranted. In addition, the FDA reviewed a meta-analysis of studies conducted in patients undergoing open heart surgery in association with cardiopulmonary bypass and determined that an additional warning about excessive bleeding was needed in the Warnings and Precautions Section of the package insert. The FDA has created a list of recommendations for patients and healthcare providers to consider before use of HES solutions.
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