FDA Requires Expanded Black Box Warning for Hydroxyethyl Starch Products Used to Treat and Prevent Hypovolemia

FDA Requires Expanded Black Box Warning for Hydroxyethyl Starch Products Used to Treat and Prevent Hypovolemia

July 12, 2021 – The U.S. FDA is requiring an expanded black box warning for hydroxyethyl starch (HES) products, which are used in intravenous solutions to treat and prevent hypovolemia (low blood volume).

The expanded black box warning cautions that there is a risk of renal injury, excess bleeding, and death associated with HES products. In addition, the FDA recommends against the use of HES products unless there are no adequate alternative treatment options available. Previously, the black box warning only advised against the use of HES in critically ill patients due to a risk of increased mortality and renal replacement therapy.

Four HES products are currently FDA approved for use in the United States: BioTime’s Hextend^® (hetastarch), Fresenius Kabi’s Voluven^® (hydroxyethyl starch), B. Braun Medical’s Hespan^® (hetastarch), and a Hespan generic from Hospira.