FDA Piles on New Warnings for Blood Volume Expanders

Hydroxyethyl starch (HES) products should not be used to treat hypovolemia unless these synthetic colloids are absolutely necessary, warned FDA in a safety communication.

The agency is requiring the black box warning on these blood volume expanders to be updated with new language regarding increased risk of mortality, acute kidney injury, and excess bleeding when used in surgical patients. Safety labels must also highlight the excess risks of mortality and acute kidney injury associated with HES use in blunt trauma patients.

Overall, there need to be new warnings added to the indications and usage, contraindications, warnings and precautions, and adverse reactions sections of the prescribing information of any HES product, FDA said.

"Do not use HES products unless adequate alternative treatment is unavailable," FDA ultimately recommended in their communication.

HES solutions contain a synthetic starch that doesn't dissolve in water. Alternative blood volume expanders (e.g., IV albumin, dextran, gelatin, and hypertonic saline) offer other ways to restore volume lost during surgery.

There are three HES products on the market, all derived from corn: Hespan (6% hetastarch in 0.9% sodium chloride injection), Hextend (6% hetastarch in lactated electrolyte injection), and Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection).

Hespan and Hextend are FDA approved for the treatment of hypovolemia, whereas Voluven is indicated for both treatment and prophylaxis.

FDA's warning comes after a multitude of observational and randomized studies suggested harm from HES solutions to patients undergoing cardiac surgery, kidney transplant, cystectomy, blunt trauma treatment, and other operations.

The agency first required a boxed warning about kidney injury and death risks associated with HES use starting in 2013.

That same year, Europe also started a safety review of these products. Although the European Medicines Agency's Pharmacovigilance Risk Assessment Committee recommended in 2018 that HES solutions be pulled from the market, regulators there have opted to keep these products available under restrictions.

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