FDA Warns of Higher Mortality Risk With Hydroxyethyl Starch Solution

Disclosures

June 24, 2013

Clinicians should not use hydroxyethyl starch (HES) solution in critically ill patients, including those with sepsis and those admitted to the intensive care unit, the US Food and Drug Administration (FDA) announced today.

These instructions, which will appear in a boxed warning on the drug's label, spring from an FDA study indicating a higher risk for renal injury and mortality in these critically ill patients. In addition, the study revealed an increased risk for excess bleeding in patients undergoing open heart surgery in association with cardiopulmonary bypass. The label's Warnings and Precautions section will advise clinicians to avoid using HES solutions in such cardiac patients.

Clinicians rely on HES solutions to expand plasma volume in patients with hypovolemia. There are 4 FDA-approved HES solutions on the market for this condition: 6% HES 450/0.7 in sodium chloride injection (Hespan, B. Braun Medical), 6% HES 450/0.7 in physiological solution (Hextend, BioTime), 6% HES 130/0.4 in normal saline (Voluven, Fresenius Kabi), and a generic equivalent to Hespan (Hetastarch, Teva Pharmaceuticals).

The FDA action comes a week after European Union drug regulators recommended pulling HES solutions from various national markets because new evidence shows that their benefits no longer outweigh their risks. The recommendation, made by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), goes to another EU body called the Coordination Group for Mutual Recognition and Decentralised Procedures–Human for a final decision.

Instead of withdrawing HES solutions from the US market, the FDA is attempting to limit their use. The FDA also recommends that clinicians:

  • Avoid using HES solutions in patients with preexisting renal dysfunction

  • Stop HES therapy at the first sign of renal injury

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

  • Stop the therapy at the first sign of coagulopathy

More information on today's announcement is available on the FDA Web site.

To report problems with HES solutions, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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