Hydroxyethyl Starch Solutions: FDA Safety Communication - Boxed Warning on Increased Mortality and Severe Renal Injury and Risk of Bleeding

The US FDA has issued a safety communication warning about the increased risk of mortality, severe renal injury, and risk of bleeding in patients receiving hydroxyethyl starch solutions.

The FDA makes the following recommendations for health professionals (taken directly from source):

• Do not use HES solutions in critically ill adult patients including those with sepsis, and those admitted to the ICU.

• Avoid use in patients with pre-existing renal dysfunction.

• Discontinue use of HES at the first sign of renal injury.

• Need for renal replacement therapy has been reported up to 90 days after HES administration. Continue to monitor renal function for at least 90 days in all patients.

• Avoid use in patients undergoing open heart surgery in association with cardiopulmonary bypass due to excess bleeding.

• Discontinue use of HES at the first sign of coagulopathy.

 

Separately, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded following a review of the available evidence that the benefits of infusion solutions containing hydroxyethyl-starch (HES) no longer outweigh their risks and therefore recommended that the marketing authorisations for these medicines be suspended.