FDA Issues Safety Communication Over Hydroxyethyl Starch (HES) Solutions

Hydroxethyl_Starch_RisksThe U.S. Food and Drug Administration (FDA) just issued a Safety Communication and called for a boxed warning that discusses the increased risks for mortality and severe renal injury, as well as additional warnings on bleeding risks, associated with hydroxyethyl starch (HES) solutions under some conditions.

HES solutions are used to treat hypovolemia—low blood volume—when plasma volume expansion is called for; however, recent data have made an association between the use of HES solutions with increased risks of severe adverse events when use in certain patients.

The data the agency reviewed indicates 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 ICU. The data also revealed a risk of excess bleeding, particularly in patients undergoing open heart surgery in association with cardiopulmonary bypass. Additional caution regarding the use of these products is also warranted, according to the FDA.

On September 6 and 7, 2012, the agency convened a Public Workshop with the National Heart, Lung, and Blood Institute at the National Institutes of Health; the U.S. Army Materiel Command, Department of Defense; and the Office of the Assistant Secretary of Health, Health ,and Human Services to discuss the risks and benefits associated with use of HES solutions.

Panelists presented data from randomized controlled trials, meta-analyses, and observational studies. This research revealed increased risks of death and/or renal injury that required renal replacement therapy, for instance, in cases of severe renal injury, when HES was used in critically ill adult patients, including patients diagnosed with sepsis and patients who were admitted to intensive care unit.

The FDA completed its analysis of the various studies, indicating increased mortality and renal injury requiring renal replacement therapy in critically ill adult patients—including those with sepsis and those admitted to the intensive care unit—who are treated with HES solutions.

FDA has concluded that HES solutions should not be used in these patient populations, and that a Boxed Warning to include the risk of mortality and severe renal injury is warranted.

The FDA also 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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