Hydroxyethyl starch (HES) solutions are used to treat hypovolemia (low blood volume) that may result from trauma, sepsis, burns, or anaphylaxis. The solutions are administered intravenously to patients in order to maintain or expand plasma volume. HES products are used prior to hospitalization, as well as during it, in both military and civilian settings. Recent data has linked the use of these products with an increased risk of severe adverse events for some patient populations.
According to the U.S. Food and Drug Administration (FDA), HES solutions can cause an increased risk of mortality and renal injury among critically ill adult patients, including those with sepsis (a serious complication that can develop from infection) and those admitted to the intensive care unit; they can also cause patients undergoing open heart surgery in conjunction with a cardiopulmonary bypass to bleed extensively. The regulator said additional caution is needed regarding the use of these products.
Health Canada along with the manufacturers of the blood volume expanders containing (HES) reiterated the risks in a June 24, 2012 communication. Stating, specifically, HES solutions should not be used:
- in patients with sepsis
- in patients with severe liver disease
- in certain types of patients with severe liver disease
Some recent studies have compared HES with other blood volume expanders in critically ill patients with sepsis. These studies suggest that patients treated with HES are at a higher risk of kidney failure or death.
The FDA Decided HES Solutions Need Warnings on Labels
In September 2012, the FDA discussed the risks and benefits of HES solutions at a public workshop; also in attendance were the National Heart, Lung, and Blood Institute of the National Institutes of Health; the U.S. Army Materiel Command, Department of Defense; and the Office of the Assistant Secretary of Health, Health and Human Services.
Panelists from the various agencies and departments presented data from randomized controlled trials and other types of studies that indicated HES brought an increased risk of mortality and/or renal injury requiring renal replacement therapy (RRT) when it was used on critically ill adult patients.
The FDA, therefore, concluded that HES solutions should not be used on patients in these populations – and that a boxed warning showcasing these risks was called for. In addition, the FDA reviewed an analysis of studies conducted on patients undergoing open heart surgery combined with cardiopulmonary bypass, and determined an additional warning of excessive bleeding was needed in the package insert.
Recommendations, Symptoms for Patients
Patients should be aware of the risks associated with the use of HES solutions and discuss them with their healthcare provider. Further, they should:
- Understand that severe kidney damage has been associated with the use of HES solutions.
- See their healthcare provider as required and follow their instructions.
- Report unusual symptoms immediately.
Symptoms of kidney damage, such as what can be caused by the use of HES solutions, include:
- change in the frequency, amount, or color of one’s urine
- bloody urine
- difficulty urinating
- swelling of legs, ankles, feet, face, or hands
- unusual weakness or fatigue
- nausea and vomiting
- shortness of breath
FDA has Approved Four HES Products
- HESPAN (6% HES 450/0.7a in Sodium Chloride Injection; B. Braun Medical Inc.)
- Hetastarch (6%) in 0.9% Sodium Chloride Injection (generic equivalent to HESPAN; Teva Pharmaceuticals USA)
- HEXTEND (6% HES 450/0.7 in physiological solution; BioTime Inc)
- Voluven (6% HES 130/0.4 in normal saline; Fresenius Kabi USA, LLC)
If you or a loved one has suffered kidney damage, severe bleeding or other side effects resulting from being treated with HES solutions, you may have valuable legal rights. To find out more, please fill out our online form or call us at 1(800)-YOURLAWYER.