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PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY October 2013 | Archived Issues

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Hydroxyethyl Starch Solutions Removed From Formulary

Pharmacy Focus

Due to the risks associated with the use of hydroxyethyl starch (HES) solutions, and the availability of safer and equally efficacious alternatives, the Pharmacy and Therapeutics Committee has approved the removal of Hespan from the formulary. All Hespan products have been removed from the units and ORs, and will no longer be available to order in CS-Link™.

The decision to remove Hespan from the formulary was based on a recent black box warning from the U.S. Food and Drug Administration for increased mortality and severe renal injury, as well as an additional warning for bleeding risk in certain settings for hydroxyethyl starch solutions.

Recommendations from the FDA include the following:

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

Learn more at this FDA Web page.

Contact the Cedars-Sinai Drug Use Policy Center at 310-423-3784 with any questions.