Hydroxyethyl Starch Solutions Get Boxed Warning.

Hydroxyethyl starch solutions should not be used in critically ill patients, including those with sepsis and those admitted to the ICU, because they pose an increased risk for mortality and severe renal injury, the FDA has announced. A boxed warning will be added to the solutions’ labels to emphasize these risks.

Providers are also advised to avoid using HES solutions in patients with preexisting renal dysfunction. Treatment should be stopped at the first sign of renal injury; renal function should be monitored in all patients for 90 days after treatment.

In addition, the FDA says, HES solutions should be avoided in patients undergoing open heart surgery in association with cardiopulmonary bypass, given an increased risk for excessive bleeding. A separate warning about this risk will be added to the Warnings and Precautions section of the label.

Source: FDA


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