FDA Issues Safety Alert Regarding Use of Hydroxyethyl Starch Products

The Food and Drug Administration (FDA) is requiring that the Boxed Warning for hydroxyethyl starch products be amended to include language about the risk of renal injury, excess bleeding, and death associated with these products. 

There are currently 4 FDA-approved hydroxyethyl starch (HES) products on the market: Hespan (6% hetastarch in 0.9% sodium chloride injection; B. Braun Medical Inc.) and its generic (6% hetastarch in 0.9% sodium chloride injection; Hospira, Inc), Hextend (6% hetastarch in lactated electrolyte injection; BioTime, Inc.), and Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection; Fresenius Kabi).

Hespan and Hextend are indicated for the treatment of hypovolemia when plasma volume expansion is desired. Voluven is indicated for the treatment and prophylaxis of hypovolemia in adults and children.

Following a review of data from randomized clinical trials, meta-analyses, and observational studies, the FDA has concluded the use of HES products is associated with serious risks that require updates to the prescribing information. Among surgical patients treated with HES products, safety signals for acute kidney injury (including a need for renal replacement therapy), coagulopathy, and mortality were observed. Additionally, studies involving blunt trauma patients found that treatment with HES products increased the risk of acute kidney injury and death. 

Based on these findings, the FDA is recommending that HES products not be used unless adequate alternative treatment is unavailable.

Reference

Labeling changes on mortality, kidney injury, and excess bleeding with hydroxyethyl starch products. [press release]. Silver Spring, MD: US Food and Drug Administration; July 7, 2021.