HES Solutions Receive Black Box Warning for Kidney Injury, Death Risk

The FDA is warning some patients against the use of hydroxyethyl starch (HES) solutions, which have caused severe side effects, including death, in some patients.

In a safety communication issued June 24, the FDA indicates that HES solutions should not be used for critically ill adult patients with sepsis and those admitted to an ICU, as it may increase the risk of death or renal injury resulting in the need for a kidney transplant.

Many patients using HES to treat hypovolemia use the medication for plasma expansion, an outcome which can become lethal for some patients. The FDA indicates that a “black box” warning for HES solutions will be added to warn patients of the risks.

Hydroxyethyl starch is a nonionic starch that is one of the most frequently used volume expanders. It is often administered intravenously as fluid replacement or given following severe trauma or surgery to help prevent shock or to aid with severe blood loss. It is sold under various brand names including, Hespan and Voluven.

The FDA convened a special Public Workshop collaboration to discuss the risks, which brought together representatives of the National Heart, Lung, and Blood Institute, the U.S. Army Materiel Command, Department of Defense, and the Office of the Assistant Secretary of Health. The panel presented data from randomized controlled trials, meta-analyses and observational studies concerning HES and its use in certain at risk populations.

The FDA reviewed the data from these studies and found HES solutions increased a patients risk of rapid loss of kidney function and death in critically ill adult patients, especially patients who have experienced sepsis or have been admitted to the ICU. Because of these findings the FDA is warning patients not to use HES if they have any of these conditions.

The research also showed that patients taking HES also face an increased risk of excess bleeding. Specifically patients who are undergoing open heart surgery because of cardio pulmonary bypass face a greater risk. This prompted the FDA to also add new information regarding the risk of excess bleeding problems to the Warnings and Precautions Section of the package insert.

The FDA recommends patients who may be at risk of these side effects discuss their concerns with their doctor before discontinuing use. Officials also recommend health care professionals advise patients to discontinue use of HES at the first signs of injury to the kidneys and warns doctors to monitor kidney function for at least 90 days after a patient has taken HES.